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

Launched by FERRING PHARMACEUTICALS · Jun 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for women trying to get pregnant. Specifically, it’s studying how a medication called FE 999302 works when given alongside another medication, Follitropin delta, during a process called controlled ovarian stimulation. This process helps stimulate the ovaries to produce eggs for in vitro fertilization (IVF). The main goal of the trial is to see how many good-quality embryos, known as blastocysts, can be created five days after retrieving the eggs. Researchers will also look at other factors, such as hormone levels and the number of eggs retrieved.

To participate, women must be between 18 and 40 years old, in good health, and have been trying to conceive for at least a year (or six months if they are over 35). They should be diagnosed with certain types of infertility, like tubal infertility or unexplained infertility, and must have regular menstrual cycles. Participants will receive treatment and be monitored throughout the process, with several tests and evaluations to track their progress. It’s important to note that certain health conditions or a history of poor response in previous fertility treatments may exclude individuals from this trial.

Gender

FEMALE

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 15.0-35.0 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 30.0 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 or higher. Poor response is defined as \<4 oocytes retrieved, or cycle cancellation before oocyte retrieval due to inadequate follicular development.
• • 3. Excessive ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI using a daily FSH/ human menopausal gonadotropin (hMG) dose of ≤225 IU, defined as ≥25 oocytes retrieved or cycle cancellation before oocyte retrieval due to excessive ovarian response, including risk of ovarian hyperstimulation syndrome (OHSS).
• • 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. Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy \[excluding ectopic pregnancy\] and before week 24 of pregnancy).
• • 6. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
• • 7. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver, or kidney) with the exception of controlled thyroid function disease.
• • 8. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary, or hypothalamus which would contraindicate the use of gonadotropins.
• • 9. 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.
• • 10. Currently breast-feeding.
• • 11. Undiagnosed vaginal bleeding.
• • 12. 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.
• • 13. Pregnancy (negative urinary pregnancy tests must be documented at screening and before randomisation) or contraindication to pregnancy.
• • 14. Use of fertility modifiers during the last menstrual cycle before start of stimulation in the trial, including dehydroepiandrosterone (DHEA) and metformin or cycle programming with oral contraceptives, progestogen, or estrogen preparations