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?
NCT06732843 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10
Last updated 2025-07-25
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.
Conditions
- OVARIAN STIMULATION
- Telomere Length
- Telomere Length, Mean Leukocyte
Sponsors & Collaborators
- collaborator INDUSTRY
-
ART Fertility Clinics LLC
lead OTHER
Principal Investigators
-
Barbara Lawrenz, PhD · ART Fertility Clinics LLC
Eligibility
- Min Age
- 18 Years
- Max Age
- 38 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-23
- Primary Completion
- 2026-12-31
- Completion
- 2027-07-31
Countries
- United Arab Emirates
Study Locations
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