Actively Recruiting

Age: 18Years - 38Years
FEMALE
Healthy Volunteers
ID06732843

Does Recombinant FSH (Gonal-F) Compared to Human Menopausal Gonadotropin (hMG) Affect Telomere Length of Cumulus Cells During Follicle Growth and Impact Blastocyst Quality?

Led by ART Fertility Clinics LLC · Updated on 2025-07-25

10

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

A

ART Fertility Clinics LLC

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying whether two different fertility medications, recombinant follicle-stimulating hormone (rFSH, Gonal-F4) and human menopausal gonadotropin (hMG, Menopur4), affect the length of telomeres in cumulus cells during egg development and how this might impact embryo quality. This observational, randomized, open-label, cross-over study focuses on women who respond normally to ovarian stimulation and aims to understand differences in embryo development related to these medications. Participants will undergo two ovarian stimulation cycles, each using either Gonal-F or hMG, with initial doses based on ovarian reserve and identical starting dosages for both cycles. Dose adjustments may begin on day 6, with a fixed antagonist from day 5, and final egg maturation triggered by a dual trigger of 2,500 IU urinary hCG and 0.3 mg Decapeptyl. The study compares effects within the same patient across both stimulation types. During the study, hormonal analysis and telomere length measurement in cumulus cells will be performed, along with assessments of embryo quality markers such as morphokinetics development, euploidy, and mitochondrial status of blastocysts. The primary outcome is the telomere length difference between the two stimulation cycles within the same woman, measured over approximately 12 weeks. Participants will be closely monitored throughout the process to evaluate these biological markers and embryo development outcomes.

CONDITIONS

Brief 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?

Who Can Participate

Age: 18Years - 38Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Maternal age 18 to 38 years
  • Patients requesting PGT-A
  • Body mass index (BMI) between 18 and 30 kg/m2
  • Expected normal ovarian responders
  • Fresh autologous ejaculate with sperm count 65 million/ml
  • Sperm abstinence of 2 to 3 days before collection
  • Normal female and male karyotype
  • Regular menstrual cycles lasting 25 to 32 days
  • Antral follicle count (AFC) of 5 to 10 in each ovary at stimulation start
  • Use of a dual trigger for final oocyte maturation: 2,500 IU urinary hCG plus 0.3 mg Decapeptyl
  • Wash-out period between 1 to 3 months between stimulation cycles
  • Agreement to complete two stimulation cycles before embryo transfer
Not Eligible

You will not qualify if you...

  • Uterine abnormalities diagnosed by ultrasound
  • Hormonal or oral contraceptive pretreatment within 3 months before treatment
  • Endometriosis classified as stage 3 or higher by American Fertility Society
  • History of two or more miscarriages
  • Poor ovarian response defined by Bologna criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 3 months between cycles plus time for two stimulation cycles

Participants undergo two ovarian stimulation cycles using different medications (rFSH and hMG) with hormonal analysis and telomere length assessment of oocyte cumulus cells during follicle growth.

Multiple visits during two stimulation cycles with dose adjustments starting from day 6 and antagonist suppression fixed from day 5 onwards

Monitoring

Duration - Up to 12 weeks post stimulation

Participants have embryo/blastocyst quality assessments including morphokinetics, euploidy, and mitochondria status evaluation following stimulation cycles.

Follow-up visits for embryo analysis after stimulation cycles

Trial Site Locations

Total: 1 location

1

ART Fertility Clinics

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Actively Recruiting

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Research Team

D

Daniela Nogueira

J

Jonalyn DV Edades

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Assessment of Telomere Length and Mitochondrial DNA Copy Number in Granulosa Cells as Predictors of Aneuploidy Rate in Young Patients.

Tzu-Ning Yu, En-Hui Cheng, Han-Ni Tsai...

https://pubmed.ncbi.nlm.nih.gov/35407431

GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study.

J Haas, R Bassil, N Samara...

https://pubmed.ncbi.nlm.nih.gov/32563188