Correlation of telomere length and telomerase activity with occult ovarian insufficiency.
Samantha Butts, Harold Riethman, Sarah Ratcliffe...
https://pubmed.ncbi.nlm.nih.gov/19864453/Actively Recruiting
Led by ART Fertility Clinics LLC · Updated on 2025-07-25
10
Participants Needed
1
Research Sites
30 weeks
Total Duration
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
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?
D
Daniela Nogueira
J
Jonalyn DV Edades
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ART Fertility Clinics LLC
Lead Sponsor
Merck Sharp & Dohme LLC
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/22244781/ART Fertility Clinics LLC
Lead Sponsor
Merck Sharp & Dohme LLC
Collaborating Sponsor