Investigating FE 999302 with Follitropin Delta for Infertility Treatment

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.

This study is testing if giving a new drug called FE 999302 along with Follitropin delta can help women with certain infertility issues have better chances of getting pregnant.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Ferring Pharmaceuticals (industry)
• Locations: 15 sites (Brussel and 14 other locations)
• Trial ID: NCT06511791 on ClinicalTrials.gov

What this trial studies

This phase 1b clinical trial explores the effects of FE 999302 when administered alongside Follitropin delta during controlled ovarian stimulation in women. It is a multicenter, randomized, double-blind, placebo-controlled trial that aims to determine how different timing of FE 999302 administration influences pregnancy rates. The primary endpoint is the number of good-quality blastocysts on day 5 after oocyte retrieval, with secondary endpoints including hormone levels, number of follicles, and pregnancy outcomes. The study involves women aged 18 to 40 with specific infertility diagnoses.

Who should consider this trial

Good fit: Ideal candidates are pre-menopausal women aged 18 to 40 with specific infertility diagnoses eligible for IVF or ICSI.

Not a fit: Patients with infertility not related to the specified conditions or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve pregnancy rates in women undergoing fertility treatments.

How similar studies have performed: Other studies have shown promise in using similar hormonal treatments for infertility, but this specific approach is exploratory.

Eligibility criteria

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.

Exclusion Criteria:

1. Known polycystic ovary syndrome (PCOS) or known endometriosis stage III-IV (American Society for Reproductive Medicine, 2012).
2. Poor response in a previous controlled ovarian stimulation cycle using a gonadotropin starting dose of 150 IU/day (corresponding to 10 µg follitropin delta) or higher. Poor response is defined as \<4 oocytes retrieved, or cycle cancellation before oocyte retrieval due to inadequate follicular development.
3. Severe ovarian hyperstimulation syndrome (OHSS; grade 4 or 5) in a previous controlled ovarian stimulation cycle, as judged by the investigator.
4. One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound before randomisation on stimulation day 1 (puncture of cysts is allowed before randomisation).
5. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
6. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver, or kidney) with the exception of controlled thyroid function disease.
7. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary, or hypothalamus which would contraindicate the use of gonadotropins.
8. Any abnormal finding of clinical chemistry and haematology at screening or vital signs at randomisation, which is judged clinically relevant by the investigator and/or requires intervention.
9. Currently breast-feeding.
10. Undiagnosed vaginal bleeding.
11. Findings at the gynaecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device.
12. Pregnancy (negative urinary pregnancy tests must be documented at screening and before randomisation) or contraindication to pregnancy.
13. Use of fertility modifiers during the last menstrual cycle before screening, including dehydroepiandrosterone (DHEA) and metformin or cycle programming with oral contraceptives, progestogen, or estrogen preparations.

Where this trial is running

Brussel and 14 other locations

• Ferring Investigational Site — Brussel, Belgium (RECRUITING)
• Ferring Investigational Site — Edegem, Belgium (RECRUITING)
• Ferring Investigational Site — Prague, Czechia (RECRUITING)
• Ferring Investigational Site — Prague, Czechia (RECRUITING)
• Ferring Investigational Site — Prague, Czechia (RECRUITING)
• Ferring Investigational Site — Copenhagen, Denmark (RECRUITING)
• Ferring Investigational Site — Hvidovre, Denmark (RECRUITING)
• Ferring Investigational Site — Bergen, Norway (RECRUITING)
• Ferring Investigational Site — Porsgrunn, Norway (RECRUITING)
• Ferring Investigational Site — Trondheim, Norway (RECRUITING)
• Ferring Investigational Site — Barcelona, Spain (RECRUITING)
• Ferring Investigational Site — Madrid, Spain (RECRUITING)
• Ferring Investigational Site — Madrid, Spain (RECRUITING)
• Ferring Investigational Site — Sevilla, Spain (RECRUITING)
• Ferring Investigational Site — Valencia, Spain (RECRUITING)

Study contacts

• Study coordinator: Global Clinical Compliance

Conditions: Infertility