Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.

Launched by FUNDACIÓN SANTIAGO DEXEUS FONT · Nov 10, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to help women preserve their fertility. The study compares a method using two doses of a hormone called Corifollitropin alpha (CFA) to another method that starts with CFA and then adds a different hormone called recombinant Follicle-Stimulating Hormone (rFSH). The goal is to see which method produces more mature eggs, which are important for fertility. This trial is important for women who might want to preserve their ability to have children in the future.

To be eligible for this study, women need to be between 18 and 40 years old, have a specific number of small follicles in their ovaries (20 or fewer), and meet certain hormone level requirements. Participants should also be healthy enough to come to the center for regular appointments and blood tests. If you join the trial, you'll receive the assigned treatment and be closely monitored throughout the process. It's essential to know that this study is focused on women who are not facing fertility issues for medical reasons, meaning it's for those seeking to preserve their fertility for personal choices.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • AFC ≤20
• • Anti-Mullerian hormone (AMH) ≤3ng/ml (AMH result of up to one year will be valid)
• • Between 18 and 40 years old
• • BMI \>18 and \<30 kg/m2
• • Body weight \> 50 kg for \> 36 years
• • Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation.
• Exclusion Criteria:
• • Medically indicated fertility preservation
• • AFC \> 20
• • Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria
• • FSH ≥ 20
• • History of untreated autoimmune, endocrine or metabolic disorders
• • Contraindication for hormonal treatment
• • Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).