Infertility
Conditions
Brief 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.
Interventions
DRUGFE 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
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
DRUGPlacebo FE 999302
No active ingredient, subcutaneous injection.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double-blind
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Subject informed consent form signed before any trial-related activities. 2. In good physical and mental health as judged by the investigator. 3. Serum anti-Müllerian hormone (AMH) levels of \>35.0 pmol/L at screening (measured at central laboratory). 4. Pre-menopausal women between the ages of 18 and 40 years. The subjects must be at least 18 years (including the 18th birthday) and no more than 40 years (up to the day before the 41st birthday) when they sign the informed consent(s). 5. Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor. 6. Infertility for at least 1 year before screening for subjects \<35 years or for at least 6 months for subjects ≥35 years (not applicable in case of tubal or severe male factor infertility). 7. No more than two controlled ovarian stimulation cycles initiated, regardless of outcome (taking
Exclusion criteria
2 and 3 into account) and the subject must be suitable for treatment with 10 or 15 µg/day follitropin delta (corresponding to 150 or 225 IU). 8. Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory. 9. Early follicular phase (cycle day 2-5) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (measured at central laboratory). 10. Body mass index (BMI) between 18.0 and 32.0 kg/m2 (both inclusive) at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of good-quality blastocysts | Day 5 | Number of good-quality blastocysts on day 5 after oocyte retrieval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Size of Follicles | Day 5 and up to 20 days | Number of follicles by size category on stimulation day 5 and at end-of-stimulation |
| Serum hormone concentrations | Day 5, up to 20 days, and up to 22 days | Serum hormone concentrations of progesterone, androstenedione, estradiol, inhibin B, and luteinising hormone (LH). |
| Number of Stimulation Days | Up to 20 days | Number of stimulation days |
| Number of Oocytes | Up to 22 days | Number of oocytes retrieved |
| Number of metaphase II oocytes | Up to 22 days | Number of metaphase II (MII) oocytes |
| Number of fertilised oocytes | Up to 22 days | Number of fertilised (2 pronuclei \[2PN\]) oocytes |
| Number of blastocysts | Up to 27 days | Number of blastocysts |
| Number of cryopreserved blastocysts | Up to 28 days | Number of cryopreserved blastocysts |
| Endometrial thickness | Up to 20 days and up to 27 days | Endometrial thickness |
| Positive βhCG | 13-15 days after fresh transfer | Positive βhCG |
| Clinical pregnancy | 5-6 weeks after fresh transfer | Clinical pregnancy measured by at least one gestational sac 5-6 weeks after fresh transfer |
| Vital pregnancy | 5-6 weeks after fresh transfer | Vital pregnancy measured by at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after fresh transfer |
| Ongoing pregnancy | 10-11 weeks after fresh transfer | Ongoing pregnancy measured by at least one intrauterine viable fetus 10-11 weeks after fresh transfer |
Countries
Belgium, Czechia, Denmark, Norway, Spain
Contacts
STUDY_DIRECTORFerring Pharmaceuticals
Ferring Pharmaceuticals
Outcome results
None listed