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? (rFSH and hMG)

July 24, 2025 updated by: ART Fertility Clinics LLC

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Normo-ovarian response patients who undergo an IVF treatment.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normo-ovarian response patients who undergo an IVF treatment including PGT-A

Patients will follow the stimulation protocol outlined below:

Initial doses will be based on ovarian reserve parameters, with the starting dosage identical for both stimulation cycles (Gonal-F® or hMG):

Dose adjustments may be made starting from day 6 Antagonist suppression will be fixed from day 5 onwards Final oocyte maturation will be triggered with a dual trigger: 2,500 IU urinary hCG and 0.3 mg Decapeptyl.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In this study the investigators will investigate the telomere length of cumulus cells between two stimulation cycles, using different stimulation medication (rFSH versus hMG) within same patient/woman
Time Frame: 12 weeks
In this study the investigators will investigate the telomere length of cumulus cells between two stimulation cycles, using different stimulation medication (rFSH versus hMG) within same patient/woman
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Barbara Lawrenz, PhD, ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Actual)

December 13, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2212-ABU-012-DN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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