The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles
Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT)
1 other identifier
interventional
600
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2017
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedStudy Start
First participant enrolled
July 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2024
CompletedMarch 19, 2026
March 1, 2026
7 years
July 4, 2017
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Clinical pregnancy rate
This outcome will be calculated 2 years after enrollment of the first patient in the study
Implantation rate
This outcome will be calculated 2 years after enrollment of the first patient in the study
Miscarriage rate
This outcome will be calculated 2 years after enrollment of the first patient in the study
Study Arms (2)
Human menopausal gonadotropin (HMG)
EXPERIMENTALThis 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
Routine care
NO INTERVENTIONThis group will receive the routine care for luteal phase support
Interventions
Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles
Eligibility Criteria
You may qualify if:
- Females undergoing Intra-Cytoplasmic Sperm Injection (ICSI) cycles
- Age between 20 and 40 years
You may not qualify if:
- Females who have high response (estradiol at time of ovulation trigger is \> 5000 pg/ml or more than 15 oocytes are retrieved)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
Cairo, Greater Cairo, 11956, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abdelmaguid Ramzy, M.D.
Cairo University
- STUDY DIRECTOR
Eman Omran, M.D.
Cairo University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 4, 2017
First Posted
July 6, 2017
Study Start
July 6, 2017
Primary Completion
July 15, 2024
Study Completion
August 15, 2024
Last Updated
March 19, 2026
Record last verified: 2026-03