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

Infertility Clinical Trial

Official title:

Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209687
• Other study ID #: 3778
• Status: Recruiting
• Phase: Phase 4
• Start date: July 6, 2017
• Est. completion date: August 15, 2024

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: Eman Omran, M.D.
• Phone: 00223682030
• Email: eman.omran[@]kasralaini.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• human menopausal gonadotropin
Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles

Locations

Country	Name	City	State
Egypt	Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital	Cairo	Greater Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	The live birth rate will be calculated by a statistician for each group	This outcome will be calculated 2 years after enrollment of the first patient in the study
Secondary	Clinical pregnancy rate	The clinical pregnancy rate will be calculated by a statistician for each group	This outcome will be calculated 2 years after enrollment of the first patient in the study
Secondary	Implantation rate	The implantation rate will be calculated by a statistician for each group	This outcome will be calculated 2 years after enrollment of the first patient in the study
Secondary	Miscarriage rate	The miscarriage rate will be calculated by a statistician for each group	This outcome will be calculated 2 years after enrollment of the first patient in the study