Care: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)
Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00702520
Collaborator
(none)
15
21.5
Study Details
Study Description
Brief Summary
The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, Org 36286) treatment for the induction of multifollicular growth in women undergoing Controlled Ovarian Stimulation (COS) prior to in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) is safe for pregnant participants and their offspring.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of all women who were treated with corifollitropin alfa and became pregnant during the base Trial 38833. For this follow-up trial (38834), no investigational products will be administered and no study specific assessments are required, but information will be obtained as per standard clinical practice.
Study Design
Study Type:
Observational
Actual Enrollment
:
15 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38833 for Org 36286 (Corifollitropin Alfa)
Actual Study Start Date
:
Apr 1, 2006
Actual Primary Completion Date
:
Nov 7, 2007
Actual Study Completion Date
:
Jan 15, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Corifollitropin alpha 100 ug In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily subcutaneous (SC) injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous luteinizing hormone (LH) and follicle stimulating hormone (FSH) was confirmed by estradiol (E2) and progesterone (P) measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recombinant follicle stimulating hormone (recFSH) injections (maximally 200 IU) up to and including the day of administration of human chorionic gonadotprophin (hCG). No study medications were administered in the present P05783 study (38834, NCT00702520). |
Drug: Corifollitropin alpha (MK-8962, Org 36286) 100 ug
Subcutaneous administration of corifollitropin alpha at a dose of 100 ug
Drug: Triptorelin
Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase).
Biological: Recombinant follicle stimulating hormone (recFSH)
From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG.
Biological: Human chorionic gonadotprophin (hCG).
HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.
|
| Corifollitropin alpha 150 ug In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG. No study medications were administered in the present P05783 study (38834, NCT00702520). |
Drug: Corifollitropin alpha (MK-8962, Org 36286) 150 ug
Subcutaneous administration of corifollitropin alpha at a dose of 150 ug
Drug: Triptorelin
Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase).
Biological: Recombinant follicle stimulating hormone (recFSH)
From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG.
Biological: Human chorionic gonadotprophin (hCG).
HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.
|
Outcome Measures
Primary Outcome Measures
- Number of Expectant Mothers Experiencing Adverse Events (AEs) [Up to 1 Year]
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
- Number of Expectant Mothers Experiencing Serious AEs (SAEs) [Up to 1 Year]
An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
- Number of Infants Experiencing AEs [Up to 1 Year]
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
- Number of Infants Experiencing SAEs [Up to 1 Year]
An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
- Take-Home Baby Rate [Birth of a one or more live babies (Up to 1 year)]
The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 39 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants who received one dose of corifollitropin alfa in Trial 38833;
-
Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38833;
-
Able and willing to give written informed consent.
Exclusion Criteria:
- None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Organon and Co
ClinicalTrials.gov Identifier:
NCT00702520
Other Study ID Numbers:
- P05783
- 38834
- MK-8962-010
- 2005-000062-40
First Posted:
Jun 20, 2008
Last Update Posted:
Feb 3, 2022
Last Verified:
Feb 1, 2022
Keywords provided by Organon and Co
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Expectant Mothers Administered Corifollitropin Alpha 100 ug | Expectant Mothers Administered Corifollitropin Alpha 150 ug | Infants From Mothers Administered Corifollitropin Alpha 100 ug | Infants From Mothers Administered Cori. Alpha 150 ug |
|---|---|---|---|---|
| Arm/Group Description | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study. | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study. | Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study. | Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study. |
| Period Title: Base Study P05788 - Assigned Treatment | ||||
| STARTED | 25 | 25 | 0 | 0 |
| Treated With Corifollitropin Alpha | 25 | 24 | 0 | 0 |
| Treated With hCG and Had Oocyte Pick-up | 25 | 24 | 0 | 0 |
| COMPLETED | 25 | 24 | 0 | 0 |
| NOT COMPLETED | 0 | 1 | 0 | 0 |
| Period Title: Base Study P05788 - Assigned Treatment | ||||
| STARTED | 25 | 24 | 0 | 0 |
| Embryo Transfer | 22 | 18 | 0 | 0 |
| COMPLETED | 22 | 18 | 0 | 0 |
| NOT COMPLETED | 3 | 6 | 0 | 0 |
| Period Title: Base Study P05788 - Assigned Treatment | ||||
| STARTED | 22 | 18 | 0 | 0 |
| Ongoing Pregnancy at 10 Weeks | 7 | 8 | 0 | 0 |
| COMPLETED | 7 | 8 | 0 | 0 |
| NOT COMPLETED | 15 | 10 | 0 | 0 |
| Period Title: Base Study P05788 - Assigned Treatment | ||||
| STARTED | 7 | 8 | 8 | 11 |
| COMPLETED | 7 | 8 | 8 | 11 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Expectant Mothers Administered Corifollitropin Alpha 100 ug | Expectant Mothers Administered Corifollitropin Alpha 150 ug | Total |
|---|---|---|---|
| Arm/Group Description | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study. | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study. | Total of all reporting groups |
| Overall Participants | 7 | 8 | 15 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
30.1
(2.0)
|
31.3
(4.2)
|
30.7
(3.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
7
100%
|
8
100%
|
15
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Expectant Mothers Experiencing Adverse Events (AEs) |
|---|---|
| Description | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug. |
| Time Frame | Up to 1 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520). |
| Arm/Group Title | Expectant Mothers Administered Corifollitropin Alpha 100 ug | Expectant Mothers Administered Corifollitropin Alpha 150 ug |
|---|---|---|
| Arm/Group Description | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study. | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study. |
| Measure Participants | 7 | 8 |
| Number [Participants] |
7
100%
|
6
75%
|
| Title | Number of Expectant Mothers Experiencing Serious AEs (SAEs) |
|---|---|
| Description | An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. |
| Time Frame | Up to 1 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520). |
| Arm/Group Title | Expectant Mothers Administered Corifollitropin Alpha 100 ug | Expectant Mothers Administered Corifollitropin Alpha 150 ug |
|---|---|---|
| Arm/Group Description | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study. | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study. |
| Measure Participants | 7 | 8 |
| Number [Participants] |
2
28.6%
|
2
25%
|
| Title | Number of Infants Experiencing AEs |
|---|---|
| Description | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug. |
| Time Frame | Up to 1 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520). |
| Arm/Group Title | Infants From Mothers Administered Corifollitropin Alpha 100 ug | Infants From Mothers Administered Cori. Alpha 150 ug |
|---|---|---|
| Arm/Group Description | Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study. | Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study. |
| Measure Participants | 8 | 11 |
| Number [Participants] |
6
85.7%
|
11
137.5%
|
| Title | Number of Infants Experiencing SAEs |
|---|---|
| Description | An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. |
| Time Frame | Up to 1 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520). |
| Arm/Group Title | Infants From Mothers Administered Corifollitropin Alpha 100 ug | Infants From Mothers Administered Cori. Alpha 150 ug |
|---|---|---|
| Arm/Group Description | Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study. | Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study. |
| Measure Participants | 8 | 11 |
| Number [Participants] |
6
85.7%
|
7
87.5%
|
| Title | Take-Home Baby Rate |
|---|---|
| Description | The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351). |
| Time Frame | Birth of a one or more live babies (Up to 1 year) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants treated with Corifollitropin alpha in the base study (P05788, 38833). |
| Arm/Group Title | Expectant Mothers Administered Corifollitropin Alpha 100 ug | Expectant Mothers Administered Corifollitropin Alpha 150 ug |
|---|---|---|
| Arm/Group Description | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study. | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study. |
| Measure Participants | 25 | 24 |
| Number [Percentage of participants] |
28.0
400%
|
33.3
416.3%
|
Adverse Events
| Time Frame | Up to 1 year | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Expectant Mothers Administered Corifollitropin Alpha 100 ug | Expectant Mothers Administered Corifollitropin Alpha 150 ug | Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug | Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug | ||||
| Arm/Group Description | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the P05783 study (38834, NCT00702520). | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study. | Fetuses/Infants from mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study. | Fetuses/Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study. | ||||
All Cause Mortality |
||||||||
| Expectant Mothers Administered Corifollitropin Alpha 100 ug | Expectant Mothers Administered Corifollitropin Alpha 150 ug | Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug | Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Expectant Mothers Administered Corifollitropin Alpha 100 ug | Expectant Mothers Administered Corifollitropin Alpha 150 ug | Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug | Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/7 (28.6%) | 2/8 (25%) | 6/8 (75%) | 7/11 (63.6%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| Accessory auricle | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Atrial septal defect | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Congenital choroid plexus cyst | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Congenital labia pudendi adhesions | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Congenital laryngeal stridor | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Congenital naevus | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Pilonidal cyst congenital | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 1/11 (9.1%) | 1 |
| Pulmonary valve stenosis congenital | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Scaphocephaly | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Skull malformation | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 2/11 (18.2%) | 2 |
| Patent ductus arteriosus | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Gastrooesophageal reflux disease | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Cholestasis of pregnancy | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Infections and infestations | ||||||||
| Bronchiolitis | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Investigations | ||||||||
| Blood pressure decreased | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Hypocalcaemia | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Torticollis | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Haemangioma | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Nervous system disorders | ||||||||
| Cerebral haemorrhage | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Breech presentation | 1/7 (14.3%) | 1 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Placenta praevia | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Premature baby | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 3/11 (27.3%) | 3 |
| Premature labour | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Small for dates baby | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Threatened labour | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Vaginal haemorrhage | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Apparent life threatening event | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Intercostal retraction | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Neonatal anoxia | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Neonatal respiratory distress syndrome | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Tachypnoea | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Hair growth abnormal | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Vascular disorders | ||||||||
| Hypotension | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| Expectant Mothers Administered Corifollitropin Alpha 100 ug | Expectant Mothers Administered Corifollitropin Alpha 150 ug | Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug | Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/7 (100%) | 6/8 (75%) | 5/8 (62.5%) | 11/11 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Lymphadenopathy | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Congenital, familial and genetic disorders | ||||||||
| Craniotabes | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 0/11 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain lower | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Constipation | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Dyspepsia | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Gastric disorder | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Regurgitation | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 3/8 (37.5%) | 3 | 1/11 (9.1%) | 1 |
| Vomiting | 2/7 (28.6%) | 2 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| General disorders | ||||||||
| Fever neonatal | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Pyrexia | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Suprapubic pain | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Cholestasis | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Immune system disorders | ||||||||
| Drug hypersensitivity | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Infections and infestations | ||||||||
| Acute tonsillitis | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Bronchitis | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 2/11 (18.2%) | 2 |
| Candidiasis | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 3/11 (27.3%) | 4 |
| Ear infection | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 4/11 (36.4%) | 4 |
| Enteritis infectious | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Nasopharyngitis | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 4/11 (36.4%) | 5 |
| Pharyngitis | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Respiratory tract infection | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 2/11 (18.2%) | 2 |
| Rhinitis | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 3/8 (37.5%) | 3 | 1/11 (9.1%) | 1 |
| Urinary tract infection | 0/7 (0%) | 0 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Vaginal infection | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Vaccination complication | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Investigations | ||||||||
| Blood bilirubin increased | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Oxygen saturation decreased | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Streptococcal identification test positive | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Hypocalcaemia | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Muscle spasms | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Nervous system disorders | ||||||||
| Cerebral haemorrhage | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Migraine | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Antepartum haemorrhage | 1/7 (14.3%) | 1 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Breech presentation | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Foetal distress syndrome | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Intrapartum haemorrhage | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Meconium in amniotic fluid | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Perineal laceration | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Placenta praevia haemorrhage | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Postpartum haemorrhage | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Premature rupture of membranes | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Premature separation of placenta | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Uterine contractions during pregnancy | 3/7 (42.9%) | 3 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Pelvic pain | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Infantile apnoeic attack | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 |
| Neonatal respiratory distress syndrome | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Respiratory failure | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Rhinorrhoea | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Erythema | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 |
| Surgical and medical procedures | ||||||||
| Cervix cerclage procedure | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Uterine dilation and curettage | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Vascular disorders | ||||||||
| Hypertension | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
| Varicose vein | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by the sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to the sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
Results Point of Contact
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp. |
| Phone | 1-800-672-6372 |
| ClinicalTrialsDisclosure@merck.com |
Responsible Party:
Organon and Co
ClinicalTrials.gov Identifier:
NCT00702520
Other Study ID Numbers:
- P05783
- 38834
- MK-8962-010
- 2005-000062-40
First Posted:
Jun 20, 2008
Last Update Posted:
Feb 3, 2022
Last Verified:
Feb 1, 2022