NCT06511791

An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation.

A Randomised, Double-blind, Placebo-controlled, Parallel-group Exploratory Trial to Investigate the Effect of FE 999302 When Administered During Different Time Intervals in Women Undergoing Controlled Ovarian Stimulation With a Fixed Dose of Follitropin Delta in a Gonadotropin-releasing Hormone Antagonist Protocol.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b clinical trial with Choriogonadotropin beta (FE999302) and Follitropin delta (Rekovelle). The trial is a randomised, double blind, placebo controlled, parallel group, exploratory trial, investigating the effect of FE 999302 when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a antagonist protocol.

Detailed description

The trial is multicentre, randomized, partially double-blind, placebo-controlled, parallel-group investigating the effect of FE999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin. The primary endpoint is the number of good-quality blastocysts on day 5 after oocyte retrieval. Secondary endpoints are number of follicles by size category and serum concentration of different hormones on stimulation day 6 and end-of stimulation, the number of stimulation days and oocytes retrieved, the number of metaphase II oocytes and fertilised oocytes, number of blastocysts on day 5, number of cryopreserved blastocysts, endometrial thickness at eos, positive bhcg rate, clinical pregnancy, vital pregnancy and ongoing pregnancy.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	FE 999302	Effect on parameters influencing pregnancy rates when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
DRUG	Follitropin delta	The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
DRUG	Placebo FE 999302	No active ingredient, subcutaneous injection.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-10-16
• Completion: 2025-10-16
• First posted: 2024-07-22
• Last updated: 2026-03-30

Locations

15 sites across 5 countries: Belgium, Czechia, Denmark, Norway, Spain