An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin … (NCT06511791) | Clinical Trial Compass
TerminatedPhase 1
An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation.
Stopped: This is a company decision made not related to safety concerns. Rather, it reflects a broader portfolio assessment and the desire to focus on programs that can bring timely and meaningful benefit to patients.
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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. Subject informed consent form signed before any trial-related activities.
✓. In good physical and mental health as judged by the investigator.
✓. Serum anti-Müllerian hormone (AMH) levels of \>35.0 pmol/L at screening (measured at central laboratory).
✓. 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).
✓. 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.
✓. 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).
Exclusion criteria
✕. Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
✕. Early follicular phase (cycle day 2-5) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (measured at central laboratory).
✕0. Body mass index (BMI) between 18.0 and 32.0 kg/m2 (both inclusive) at screening.
✕. Known polycystic ovary syndrome (PCOS) or known endometriosis stage III-IV (American Society for Reproductive Medicine, 2012).
✕. 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.
✕. Severe ovarian hyperstimulation syndrome (OHSS; grade 4 or 5) in a previous controlled ovarian stimulation cycle, as judged by the investigator.
✕. 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).
✕. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).