Actively Recruiting
Does Recombinant FSH (rFSH, i.g. Gonal F®) as Compared to Human Menopausal Gonadotrophin (hMG) Affect Telomere Length of Cumulus Cells During Antral Follicle Growth and Impact Blastocyst Status?
Led by ART Fertility Clinics LLC · Updated on 2025-07-25
10
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
A
ART Fertility Clinics LLC
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gonal-F® (follitropin alfa) is a recombinant FSH without LH activity, while Menopur® contains both LH and hCG. The MEGASET trial compared Menopur® and Gonal-F® in GnRH antagonist cycles with SET, showing similar efficacy. A subsequent study (MEGASET-HR) in high responders found ongoing pregnancy rates of 35.5% for Menopur® and 30.7% for Gonal-F®, with a lower early pregnancy loss for Menopur® (14.5% vs 25.5%). Telomere length (TL) in oocyte cumulus cells (CC) correlates with oocyte quality and embryo outcomes. This study aims to assess whether stimulation type (hMG vs. Gonal-F) affects TL in CC and subsequent blastocyst development. A randomized, open-label, cross-over study in normo-responders will analyze telomere length, embryo quality, and hormonal markers.
CONDITIONS
Official Title
Does Recombinant FSH (rFSH, i.g. Gonal F®) as Compared to Human Menopausal Gonadotrophin (hMG) Affect Telomere Length of Cumulus Cells During Antral Follicle Growth and Impact Blastocyst Status?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal age 18 - 38 years
- Patients requested PGT-A
- BMI 18- 30kg/m2
- Expected normoresponders
- Fresh autologous ejaculate (65 mill/ml)
- Sperm abstinence: 2-3 days
- Normal female/male karyotype
- Regular menstrual cycle length: 25-32 days
- AFC of 5-10 in each ovary at the beginning of the stimulation
- Trigger: dual trigger: 2.500 IU urinary hCG + 0.3 mg Decapeptyl
- A wash-out period between 1 to 3 months; an inter-cycle variation of 10% in AFC, measured by the same physician, is accepted
- Couple agrees to perform two stimulations before continuing with embryo transfer
You will not qualify if you...
- Uterine abnormalities as diagnosed by ultrasound
- Any hormonal or oral contraceptive pretreatment within 3 months before treatment
- Endometriosis classified as stage 3 or higher according to American Fertility Society
- History of 2 or more miscarriages
- Poor ovarian response based on Bologna criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ART Fertility Clinics
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Actively Recruiting
Research Team
D
Daniela Nogueira
CONTACT
J
Jonalyn DV Edades
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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