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?

Launched by ART FERTILITY CLINICS LLC · Dec 10, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how two different medications used in ovarian stimulation—Gonal-F® (which contains a synthetic hormone called FSH) and Menopur® (which contains both FSH and LH)—affect the length of telomeres in cumulus cells during the growth of eggs. Telomeres are protective caps on the ends of chromosomes, and their length can give us information about egg quality and the potential success of embryos. The study aims to see if the type of medication used impacts telomere length and the quality of embryos formed.

To participate in this trial, women aged 18 to 38 years who are planning to undergo preimplantation genetic testing for an embryo should meet specific health criteria, such as having a healthy body weight and regular menstrual cycles. Participants will receive both types of hormonal treatments in a randomized order and will be monitored for changes in telomere length and embryo quality. It’s important to note that participants will need to agree to undergo two rounds of ovarian stimulation before embryo transfer. This study is still in the planning phase and is not yet recruiting participants.

Gender

FEMALE

Eligibility 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)