An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation
NCT Number: NCT06466486
Acronym: Celestial-1
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Fertility
Interventions: DRUG: Follitropin delta|DRUG: FE999302|DRUG: FE999302 Placebo
Sponsor: Ferring Pharmaceuticals
Sex: FEMALE
Age: ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-14
Completion Date: 2027-09-11
Locations: Ferring Investigational Site, Brussel, 1090, Belgium|Ferring Investigational Site, Prague, 160 00, Czechia|Ferring Investigational Site, Prague, 184 00, Czechia|Ferring Investigational Site, Copenhagen, 2100, Denmark|Ferring Investigational Site, Hvidovre, 2650, Denmark|Ferring Investigational Site, Madrid, Aravaca, 28023, Spain|Ferring Investigational Site, Barcelona, 08028, Spain|Ferring Investigational Site, Sevilla, 41092, Spain|Ferring Investigational Site, Valencia, 46015, Spain

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.

Primary Outcome Measures: Number of good-quality blastocysts, The number of good-quality blastocysts, Day 5 after oocyte retrieval.
Secondary Outcome Measures: Number and size of follicles, Number of follicles by size category, On stimulation day 6 and up to 20 days|Serum hormone concentrations, Serum hormone concentrations of progesterone, 17-OH-progesterone, androstenedione, testosterone, estradiol, inhibin B, and luteinising hormone (LH) on stimulation day 6 and at end of stimulation., On stimulation day 6, and up to 20 days|Serum hormone concentrations, Serum hormone concentrations of progesterone, 17-OH-progesterone, androstenedione, testosterone, and estradiol at oocyte retrieval, Up to 22 days|Number of Stimulation days, Number of stimulation days, Up to 20 days|Number of oocytes, Number of oocytes retrieved, Up to 22 days|Number of metaphase II oocytes, Number of metaphase II (MII) oocytes, Up to 22 days|Number of fertilised oocytes, Number of fertilised (2 pronuclei \[2PN\]) oocytes, Up to 22 days|Number of blastocysts, Number of blastocysts, Up to 27 days|Number of cryopreserved blastocysts, Number of cryopreserved blastocysts, Up to 28 days|Endometrial thickness, Endometrial thickness, Up to 20 days, and up to 27 days|Positive βhCG, Positive βhCG (positive serum βhCG test ), 13 to 15 days after fresh transfer|Clinical pregnancy, Clinical pregnancy (at least one gestational sac), 5-6 weeks after fresh transfer|Vital pregnancy, Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat), 5-6 weeks after fresh transfer|Ongoing pregnancy, Ongoing pregnancy (at least one intrauterine viable fetus), 10-11 weeks after fresh transfer