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

NCT06466486 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2026-03-30

No results posted yet for this study

Summary

This is a phase 1b clinical trial with Choriogonadotropin beta (FE999302) and Follitropin delta (Rekovelle).

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

Interventions

DRUG

Follitropin delta

The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.

DRUG

FE999302

To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol

DRUG

FE999302 Placebo

To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-14
Primary Completion
2025-12-03
Completion
2025-12-03

Countries

  • Belgium
  • Czechia
  • Denmark
  • Norway
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06466486 on ClinicalTrials.gov