A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 µg or 15 µg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China
- Conditions
- Infertility, Female
- Registration Number
- NCT06173869
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 300
Inclusion Criteria:<br><br> - Signed and dated Informed Consent Form for participation in the trial, obtained<br> before any trial-related procedures.<br><br> - In good physical and mental health in the judgement of the investigator.<br><br> - Chinese pre-menopausal female between the ages of 20 and 40 years; at least 20 years<br> (including the 20th birthday) when signing the informed consent and no more than 40<br> years (up to the day before the 41st birthday) at the time of randomisation.<br><br> - Eligible for ovarian stimulation with a dose equivalent to 150 IU GONAL-F or 225 IU<br> GONAL-F, as judged by the investigator.<br><br> - Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.<br><br> - Infertile women diagnosed with tubal infertility, unexplained infertility,<br> endometriosis stage I/II or with partners diagnosed with male factor infertility,<br> eligible for in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI)<br> using fresh or frozen ejaculated sperm from male partner or sperm donor<br><br> - Infertility for at least one year before randomisation for subjects <35 years or for<br> at least 6 months for subjects =35 years (criteria not applicable in case of tubal<br> or severe male factor infertility).<br><br> - Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.<br><br> - Transvaginal ultrasound documenting presence and adequate visualisation of both<br> ovaries, without evidence of significant abnormality. Both ovaries must be<br> accessible for oocyte retrieval.<br><br> - Early follicular phase (cycle day 2-4) serum levels of follicle-stimulating hormone<br> (FSH) between 1 and 15 IU/L (results obtained within 3 months prior to<br> randomisation).<br><br> - Serum anti-Müllerian hormone (AMH) concentration of =35 pmol/L at screening.<br><br>Exclusion Criteria:<br><br> - Primary ovarian failure.<br><br> - More than three previous controlled ovarian stimulation cycles initiated, regardless<br> of outcome.<br><br> - History of previous episode of OHSS, exuberant ovarian response to gonadotropins, or<br> polycystic ovarian syndrome.<br><br> - Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or<br> kidney) which can compromise participation in the trial with the exception of<br> controlled thyroid function disease.<br><br> - Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus<br> which would contraindicate the use of gonadotropins.<br><br> - Fibroid tumours of the uterus incompatible with pregnancy.<br><br> - Currently breast-feeding.<br><br> - Known inherited or acquired thrombophilia disease.<br><br> - Active arterial or venous thromboembolism or severe thrombophlebitis, or a history<br> of these events.<br><br> - Known porphyria.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of oocytes retrieved
- Secondary Outcome Measures
Name Time Method