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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?

Recruitingn/aAges 18 Years - 38 YearsFemaleART Fertility Clinics LLC
NCT06732843 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Maternal age 18 - 38 years 2. Patients requested PGT-A 3. BMI 18- 30kg/m2 4. Expected normoresponders 5. Fresh autologous ejaculate (≥5 mill/ml) 6. Sperm abstinence: 2-3 days 7. Normal female/male karyotype 8. Regular menstrual cycle length: 25-32 days 9. AFC of 5-10 in each ovary at the beginning of the stimulation 10. Trigger: dual trigger: 2.500 IU urinary hCG + 0.3 mg Decapeptyl. (13) 11. A wash-out period between 1 to 3 months; an inter-cycle variation of 10% in AFC, measured by the same physician, is accepted. 12. Couple agrees to perform two stimulations before continuing with embryo transfer Exclusion Criteria: * 1\. 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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What it tests

  • Not listed
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Where

1 site
ART Fertility Clinics
Abu Dhabi, United Arab Emirates
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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