FSH Followed by HMG vs FSH Plus HMG in IVF
Follicle Stimulating Hormone (FSH) Followed by Human Menopausal Gonadotropin (HMG) Versus FSH Plus HMG During Controlled Ovarian Stimulation for in Vitro Fertilization
1 other identifier
interventional
530
1 country
3
Brief Summary
The aim of this study is to compare the clinical outcomes of sequential administration of FSH and HP-hMG FSH alone versus concomitant administration of FSH and HP-hMG during controlled ovarian stimulation in IVF cycles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2020
Typical duration for phase_4
3 active sites
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
January 10, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedStudy Start
First participant enrolled
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedJune 9, 2020
June 1, 2020
1.9 years
January 10, 2020
June 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ongoing pregnancy rate
Number of ongoing pregnancies (defined as pregnancies passed beyond 12 weeks gestational age) divided by the number of women randomized
12 weeks gestational age
Secondary Outcomes (3)
Clinical pregnancy rate
6 weeks after embryo transfer
Implantation rate
6 weeks after embryo transfer
Miscarriage rate
12 weeks gestational age
Study Arms (2)
FSH then HP-hMG
ACTIVE COMPARATORWomen will receive 225 IU FSH alone from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm, the 150 IU HP-hMG will substitute FSH and continued to the day of triggering
FSH + HP-hMG
ACTIVE COMPARATORWomen will receive 150 IU FSH plus 75IU HP-hMG from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm 150 IU HP-HMG till day of triggering
Interventions
Eligibility Criteria
You may qualify if:
- Women who are planned to be subjected to IVF/ICSI through COS by long GnRHa protocol.
- Women with regular menstrual cycle (21-35 days) and normal uterine anatomy (confirmed by transvaginal ultrasound examination and in some cases hysteronsalpingography and hysteroscopy).
You may not qualify if:
- Age \< 20 or \> 37 years.
- Body mass index (BMI) \< 18 or \> 30 kg/m2.
- Low ovarian reserve (AFC \< 7 and/or AMH \< 1.1 ng/ml).
- Presence of polycystic ovarian syndrome (PCOS).
- Endometrioma or hydrosalpinx.
- History of chemotherapy, radiotherapy or ovarian surgery.
- The husband needs testicular biopsy to obtain sperm.
- Previous implantation failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Fertility Care Unit (FCU) in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111, Egypt
Department of Obstetrics and Gynecology
Alexandria, Egypt
RAHEM Fertility Centre
Zagazig, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Gibreel, MD
Mansoura University
- STUDY DIRECTOR
Mohamed S Abdelhafez, MD
Mansoura University
- STUDY DIRECTOR
Hasan El Maghraby, MD
Alexandria University
- STUDY CHAIR
Hamed Yossef, MD
Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2020
First Posted
May 12, 2020
Study Start
June 30, 2020
Primary Completion
May 30, 2022
Study Completion
August 31, 2022
Last Updated
June 9, 2020
Record last verified: 2020-06