Real-world Evidence on Follitropin Delta Individual Dosing

Launched by UNIVERSITY OF LUEBECK · Dec 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called Follitropin delta works for women undergoing treatment for infertility. Follitropin delta helps stimulate the ovaries to produce eggs, and in this trial, the goal is to see how effectively it can be tailored to each woman's individual needs based on her weight and hormone levels. Unlike earlier studies, this trial includes a more diverse group of women, including those who are underweight, overweight, or have varying hormone levels, which means it aims to reflect real-world experiences in fertility clinics.

To participate in the trial, women aged between 18 and 44 who are planning to undergo IVF (a process to help with conception) and are willing to use Follitropin delta for their treatment may be eligible. Participants can expect to receive personalized dosing based on their specific body measurements and hormone tests. This study is designed to gather information on how well this individualized approach works and its safety in everyday clinical settings, helping to improve future treatments for infertility.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 to ≤ 44 years at enrolment
• • Planned stimulation in a fixed or flexible GnRH antagonist protocol
• • Planned use of follitropin delta for ovarian stimulation as per SmPC
• • Planned IVF or ICSI treatment with ejaculated or cryopreserved male germ cells, autologous or heterologous, with or without planned genetic testing of the oocytes or embryos
• • Planned preservation of MII oocytes (fertility preservation)
• • Planned triggering of final oocyte maturation with hCG or a GnRH agonist
• • Willingness and consent to participate
• Exclusion Criteria:
• • Serum AMH within 12 months prior to treatment ≤0.3 ng/ml
• • Most recent serum AMH value before start of stimulation older than 12 months
• • Serum AMH value not determined in Roche Elecsys immunoassays
• • Pre-treatment with a combined oral contraceptive "pill" consisting of ethinyl estradiol and a synthetic progestogen