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?
ART Fertility Clinics LLC
10 participants
Jul 23, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria12
- Maternal age 18 - 38 years
- Patients requested PGT-A
- BMI 18- 30kg/m2
- Expected normoresponders
- Fresh autologous ejaculate (≥5 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. (13)
- 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
Exclusion Criteria1
- \. Uterine abnormalities as diagnosed by ultrasound 2. Any hormonal or oral contraceptive pretreatment of 3 months preceding the treatment 3. Endometriosis according to American Fertility Society (AFS) ≥3 4. ≥ 2 miscarriages 5. Bologna criteria poor responders (14)
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06732843