Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

Sponsor

Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Terminated

CT.gov ID

NCT03858049

Collaborator

Merck Serono Co., Ltd. (Other)

172

Enrollment

Location

Arms

28.9

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study to compare to the efficacy and safety of Crinone versus combination medication in infertile women receive frozen-thawed embryo transfer (FET) in artificial cycles (AC).

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Crinone Drug: Duphaston	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Crinone ® Versus Combination Medication for Luteal Phase Support on the Ongoing Pregnancy Rate of Frozen-thawed Cycle in Chinese Population a Randomized, Interventional, Open-label, Phase IV, Single Center, Pilot Study (ACCESS)

Actual Study Start Date :

May 31, 2019

Actual Primary Completion Date :

Oct 27, 2021

Actual Study Completion Date :

Oct 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crinone	Drug: Crinone Participants will receive 90 milligram (mg) of intravaginal Crinone gel daily in the morning in the treatment period for approximately 75 days.
Experimental: Crinone plus Duphaston	Drug: Crinone Participants will receive 90 milligram (mg) of intravaginal Crinone gel daily in the morning in the treatment period for approximately 75 days. Drug: Duphaston Participants will receive 10 mg of Duphaston orally twice a day in the treatment period for approximately 70 days.

Arm

Intervention/Treatment

Experimental: Crinone

Drug: Crinone

Participants will receive 90 milligram (mg) of intravaginal Crinone gel daily in the morning in the treatment period for approximately 75 days.

Experimental: Crinone plus Duphaston

Drug: Crinone

Participants will receive 90 milligram (mg) of intravaginal Crinone gel daily in the morning in the treatment period for approximately 75 days.

Drug: Duphaston

Participants will receive 10 mg of Duphaston orally twice a day in the treatment period for approximately 70 days.

Outcome Measures

Primary Outcome Measures

Ongoing Pregnancy Rate [8 to 10 weeks after embryo transfer]
Ongoing pregnancy will be assessed by the presence of viable intra uterine fetus detected by ultrasound examination in 10-12 weeks of pregnancy. Ongoing pregnancy rate is defined as the number of ongoing pregnancies expressed per 100 embryo transfer cycles.

Secondary Outcome Measures

Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate [Day 14]
Beta-hCG positive rate defined as the number of Beta-hCG positive participants expressed per 100 embryo transfer cycles.
Implantation Rate [Day 35]
The number of gestational sacs observed in ultrasound scan divided by the number of embryos transferred.
Clinical Pregnancy rate [Day 35]
A pregnancy diagnosed by ultrasound of one or more gestational sacs or definitive clinical signs of pregnancy. Clinical Pregnancy rate defined as the number of clinical pregnancies expressed per 100 embryo transfer cycles.
Number of Participants With Early Abortion [Up to 12 Weeks]
Early abortion defined as the spontaneous loss of an intra-uterine pregnancy prior to 12 completed weeks of gestational age.
Luteal Phase Bleeding Rate [Up to Day 14]
Luteal Phase Bleeding defined as the onset of any bleeding after embryo transfer and prior to the pregnancy test. Luteal Phase Bleeding Rate defined as the number of the participants with luteal phase bleeding expressed per 100 embryos transferred cycles.
Vaginal Bleeding Rate [Day 14 to Day 63]
Vaginal bleeding is defined as any bleeding recorded after a pregnancy test via serum Beta-Human Chorionic Gonadotrophin. Vaginal bleeding rate defined as the number of the participants with vaginal bleeding expressed per 100 embryos transferred cycles.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

Participants who will receive artificial frozen-thawed embryo transfer (FET) cycle study interventions
Participants who have no more than two Day 5 embryos are planned to be transferred (follow the clinical practice of the study site)
Participants have received estradiol valerate for no more than 20 days
Participants have a transitional-endometrium of greater than or equal to 8 millimeter
Participants have normal uterine cavity
Participants can give signed informed consent
Participants are willing to follow the study protocol and able to complete the study

Exclusion Criteria:

Participants are willing to follow the study protocol and able to complete the study
Participants with greater than or equal to three previously failed cycles of ET
Participants with diseases that cannot tolerate pregnancy
Hydrosalpinx
Severe endometriosis (Endometriosis American Society for Reproductive Medicine (ASRM) criteria from 1996)
Known hypersensitivity to progesterone, the excipients of Crinone and Duphaston Vaginal bleeding of unknown origin
History of recurrent miscarriages
Vaginitis
Thromboembolic diseases (thrombophlebitis, thromboembolic disorder, or cerebral apoplexy) or participants with a history of these conditions
Known or suspected progestogen-dependent neoplasm
Participation in another clinical trial within the past 30 days
Contraindications of both Crinone and Duphaston