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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
106
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
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
No active ingredient, subcutaneous injection.
Ferring Investigational Site
Brussels, Belgium
Ferring Investigational Site
Edegem, Belgium
Ferring Investigational Site
Prague, Czechia
Number of good-quality blastocysts
Number of good-quality blastocysts on day 5 after oocyte retrieval
Time frame: Day 5
Number and Size of Follicles
Number of follicles by size category on stimulation day 5 and at end-of-stimulation
Time frame: Day 5 and up to 20 days
Serum hormone concentrations
Serum hormone concentrations of progesterone, androstenedione, estradiol, inhibin B, and luteinising hormone (LH).
Time frame: Day 5, up to 20 days, and up to 22 days
Number of Stimulation Days
Number of stimulation days
Time frame: Up to 20 days
Number of Oocytes
Number of oocytes retrieved
Time frame: Up to 22 days
Number of metaphase II oocytes
Number of metaphase II (MII) oocytes
Time frame: Up to 22 days
Number of fertilised oocytes
Number of fertilised (2 pronuclei \[2PN\]) oocytes
Time frame: Up to 22 days
Number of blastocysts
Number of blastocysts
Time frame: Up to 27 days
Number of cryopreserved blastocysts
Number of cryopreserved blastocysts
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Ferring Investigational Site
Prague, Czechia
Ferring Investigational Site
Prague, Czechia
Ferring Investigational Site
Copenhagen, Denmark
Ferring Investigational Site
Hvidovre, Denmark
Ferring Investigational Site
Bergen, Norway
Ferring Investigational Site
Porsgrunn, Norway
Ferring Investigational Site
Trondheim, Norway
...and 5 more locations
Time frame: Up to 28 days
Endometrial thickness
Endometrial thickness
Time frame: Up to 20 days and up to 27 days
Positive βhCG
Positive βhCG
Time frame: 13-15 days after fresh transfer
Clinical pregnancy
Clinical pregnancy measured by at least one gestational sac 5-6 weeks after fresh transfer
Time frame: 5-6 weeks after fresh transfer
Vital pregnancy
Vital pregnancy measured by at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after fresh transfer
Time frame: 5-6 weeks after fresh transfer
Ongoing pregnancy
Ongoing pregnancy measured by at least one intrauterine viable fetus 10-11 weeks after fresh transfer
Time frame: 10-11 weeks after fresh transfer