Long Protocol and Growth Hormone in Poor Responders

Sponsor

Woman's Health University Hospital, Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT02338206

Collaborator

Cairo University (Other)

240

Enrollment

Location

Arms

32.5

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Growth hormone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Growth Hormone Adjuvant Therapy With Long Down Regulation Protocol in Poor Responders Undergoing In Vitro Fertilization Cycles: a Randomized Control Trial

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Nov 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Long + Growth hormone Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously along with Growth hormone (Norditropin, Novo nordisk) co-treatment daily in a dose of 2.5 mg S.C. till the day of hCG administration.. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG and growth hormone, were continued till the day of hCG administration.	Drug: Growth hormone Other Names: Norditropin, Novo nordisk
No Intervention: Long protocol only Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG, were continued till the day of hCG administration.

Arm

Intervention/Treatment

Active Comparator: Long + Growth hormone

Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously along with Growth hormone (Norditropin, Novo nordisk) co-treatment daily in a dose of 2.5 mg S.C. till the day of hCG administration.. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG and growth hormone, were continued till the day of hCG administration.

Drug: Growth hormone

Other Names:

Norditropin, Novo nordisk

No Intervention: Long protocol only

Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG, were continued till the day of hCG administration.

Outcome Measures

Primary Outcome Measures

Live birth rate [12 months]
Fresh, Frozen, Cumulative

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Poor responder females are those who posses two out of these three criteria:
Female age ≥40 years
Females who have at least one previous cancelled IVF cycle
POR according to AFC ≤ 5 or low AMH value.

Exclusion Criteria:

Females over 45 years
Females with FSH more than 20 IU/l
Females with previous ovarian surgery
Females suffering from causes of infertility other than poor ovarian response
Females refusing to be enrolled in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr el aini hospital	Cairo		Egypt	12211

Sponsors and Collaborators

Woman's Health University Hospital, Egypt
Cairo University

Investigators

Principal Investigator: Dina M Dakhly, MD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dina Mohamed Refaat Dakhly, lecturer of obstetrics and gynecology, Woman's Health University Hospital, Egypt

ClinicalTrials.gov Identifier:

NCT02338206

Other Study ID Numbers:

LP112015

First Posted:

Jan 14, 2015

Last Update Posted:

Nov 29, 2017

Last Verified:

Nov 1, 2017

Keywords provided by Dina Mohamed Refaat Dakhly, lecturer of obstetrics and gynecology, Woman's Health University Hospital, Egypt

infertility

Additional relevant MeSH terms:

Infertility

Hormones

Study Results

No Results Posted as of Nov 29, 2017