The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles

Phase 4

Recruiting

• Conditions: Infertility
• Interventions: Drug: human menopausal gonadotropin

• Registration Number: NCT03209687
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to test the hypothesis that addition of daily small dose of human menopausal gonadotropin (HMG) drug following oocytes retrieval could improve the fertility outcome in women undergoing in-vitro fertilization

Detailed Description

The study will be conducted in the IVF unit of Cairo University. Females undergoing ICSI cycles in the age between 20 and 40 years will be allocated to one of 2 groups. Long agonist protocol will be used. Allocation to either one of 2 groups will be done on the day of oocytes retrieval. The first group will take (in addition to the routine care) daily human menopausal gonadotropin drug injection for 2 weeks. The second group will receive the routine care.

Study Timeline

• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-04
• Study Start: 2017-07-06
• Study First Posted: 2017-07-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09
• Primary Completion: 2024-07-15
• Study Completion: 2024-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Females undergoing Intra-Cytoplasmic Sperm Injection (ICSI) cycles
• Age between 20 and 40 years

Exclusion Criteria

• Females who have high response (estradiol at time of ovulation trigger is > 5000 pg/ml or more than 15 oocytes are retrieved)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human menopausal gonadotropin (HMG)	human menopausal gonadotropin	This group will take daily subcutaneous 75 IU (international unit) of human menopausal gonadotropin (HMG) in addition to the usual luteal phase support from the day of ovum pickup and will be continued for 2 weeks

Primary Outcome Measures

Name	Time	Method
Live birth rate	This outcome will be calculated 2 years after enrollment of the first patient in the study	The live birth rate will be calculated by a statistician for each group

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	This outcome will be calculated 2 years after enrollment of the first patient in the study	The clinical pregnancy rate will be calculated by a statistician for each group
Implantation rate	This outcome will be calculated 2 years after enrollment of the first patient in the study	The implantation rate will be calculated by a statistician for each group
Miscarriage rate	This outcome will be calculated 2 years after enrollment of the first patient in the study	The miscarriage rate will be calculated by a statistician for each group

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital; 🇪🇬 Cairo, Greater Cairo, Egypt