A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Fol… (NCT06173869) | Clinical Trial Compass
CompletedPhase 3
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
China301 participantsStarted 2024-03-29
Plain-language summary
This is a phase 3b clinical trial with follitropin delta (FE 999049) and Gonal-F. The trial is a randomised, controlled, assessor-blind, parallel groups, multicentre trial comparing the ovarian response of a starting dose of either 10mg or 15 mg follitropin delta to a starting dose of either 150 IU or 225 IU Gonal-F in a long GnRH agonist protocol in women undergoing an assisted reproductive technology programme in China.
Who can participate
Age range20 Years – 40 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed and dated Informed Consent Form for participation in the trial, obtained before any trial-related procedures.
* In good physical and mental health in the judgement of the investigator.
* Chinese pre-menopausal female between the ages of 20 and 40 years; at least 20 years (including the 20th birthday) when signing the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomisation.
* Eligible for ovarian stimulation with a dose equivalent to 150 IU GONAL-F or 225 IU GONAL-F, as judged by the investigator.
* Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.
* 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) or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor
* Infertility for at least one year before randomisation for subjects \<35 years or for at least 6 months for subjects ≥35 years (criteria not applicable in case of tubal or severe male factor infertility).
* Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
* Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality. Both ovaries must be accessible for oocyte retrieval.
* Early follicular phase (cycl…
What they're measuring
1
Number of Oocytes Retrieved
Timeframe: On day of oocyte retrieval (up to 22 days after start of stimulation)