rFSH versus hMG effects on cumulus cell telomere length and blastocyst development
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?
Run by ART Fertility Clinics LLC · NCT06732843 · Data updated 2026-11-12
This trial will test whether using recombinant FSH (Gonal‑F) versus human menopausal gonadotropin (Menopur) during ovarian stimulation changes cumulus cell telomere length and later blastocyst outcomes in women 18–38 undergoing IVF with PGT‑A.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 38 Years |
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | ART Fertility Clinics LLC Academic / other |
| Locations | 1 site (Abu Dhabi, Abu Dhabi Emirate) |
| Status | Recruiting |
| Started | July 23, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | July 31, 2027 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT06732843 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–38 with BMI 18–30, expected normo‑responders (AFC 5–10 per ovary), requesting PGT‑A, with normal karyotypes and willing to undergo two stimulations and clinic visits in Abu Dhabi.
✕Probably not a fit
Patients who are poor responders, have severe endometriosis, recent hormonal pretreatment, recurrent miscarriages, abnormal karyotypes, or who do not want two stimulation cycles or PGT‑A are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, open‑label, cross‑over study in expected normo‑responders comparing stimulation with rFSH (Gonal‑F) and HP‑hMG (Menopur). Each participant will undergo two stimulation cycles with a washout period, and cumulus cells will be collected to measure telomere length alongside standard embryo quality and hormonal markers. The trial builds on prior MEGASET findings showing comparable ongoing pregnancy rates but differing early pregnancy loss between the products. Outcomes will include telomere length in cumulus cells, blastocyst development metrics, and associated hormonal profiles.
Why it matters
Potential benefit: If successful, the findings could help clinicians choose the gonadotropin that better preserves oocyte/embryo quality and potentially reduce early pregnancy loss.
How similar studies have gone: Previous MEGASET and MEGASET‑HR trials showed similar ongoing pregnancy rates between Menopur and Gonal‑F and lower early pregnancy loss with HP‑hMG, while telomere length has been linked to oocyte quality, but direct head‑to‑head telomere comparisons are novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
ART Fertility Clinics
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates Recruiting
Study contacts
- Study coordinator: Daniela Nogueira
- Email: daniela.nogueira@artfertilityclinics.com
- Phone: 971504374961
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.