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?

Phase

N/A

Condition

In Vitro Fertilization

Telomeres

Treatment

N/A

Clinical Study ID

NCT06732843

2212-ABU-012-DN

Ages 18-38
Female
Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion Criteria:

Uterine abnormalities as diagnosed by ultrasound 2. Any hormonal or oralcontraceptive pretreatment of 3 months preceding the treatment 3. Endometriosisaccording to American Fertility Society (AFS) ≥3 4. ≥ 2 miscarriages 5. Bolognacriteria poor responders (14)

Study Design

July 23, 2025

July 31, 2027

Study Description

Gonal-F® (follitropin alfa) is a recombinant human follicle-stimulating hormone (rFSH), without LH activity. Urine-derived, human-menopausal-gonadotropin contains LH and hCG. A highly purified hMG, HP-HMG, Menopur® has been compared with Gonal-F® in terms of ongoing pregnancy rate in the so called MEGASET trial ("Menopur in GnRH Antagonist Cycles with Single Embryo Transfer") and both showed to be effective in GnRH antagonist cycles with SET. Another non-inferiority study was initiated in high responders - MEGASET-HR-, comparing Menopur with Gonal-F. After fresh transfer, the ongoing pregnancy rate was similar between groups: 35.5% for Menopur versus 30.7% for Gonal-F, and non-inferiority was established. However, cumulative early pregnancy loss from fresh embryo transfer cycles (ET) and frozen embryo transfer cycles (FETs) in patients treated with HP-hMG was significantly lower as compared to rFSH (14.5% vs 25.5%).

Telomere length (TL) has been long proposed as oocyte quality marker and, recently, has been correlated with pregnancy outcomes. During folliculogenesis, granulosa cells undergo successive cell divisions which can result in telomeric shortening. Telomerase is the enzyme complex that binds the chromosome ends (telomeres) and maintains telomere length and integrity. An association has been shown between telomere length in cumulus cells (CC), oocyte competence and embryo quality. Hence, with the present study, the investigators aim to explore whether the stimulation treatment type (hMG versus Gonal-F) affects the telomere length of oocytes cumulus cells reflecting on subsequent blastocyst development, to help understanding the underlying differences between both gonadotropins.

To the investigators best knowledge, there are no studies evaluating TL in CC from the same patient exposed to two different stimulations. With the present, we intend to perform a randomized, open-label, cross-over study in a selected normo-responders patient population. Patients will be submitted to hormonal analysis, to analysis of telomere length of their oocyte cumulus cells and to analysis of quality markers of its respective embryos/blastocysts. This includes morphokinetics development, euploidy and mitochondria status evaluation of cultured blastocysts.

Connect with a study center

ART Fertility Clinics
Abu Dhabi,
United Arab Emirates
Active - Recruiting

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