Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07340827
Eligibility Criteria:
Inclusion Criteria:
* Participants who are premenopausal wishing to conceive
* Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy
* Japanese Participants
* Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency congenital or acquired
* Participants have a vaginal ultrasound scan showing both ovaries and no clinically significant uterine abnormality and a normal antral follicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) in diameter per ovary
* A semen analysis of the male partner been performed within 3 months prior to signature of informed consent and suitable for assisted reproductive technology
* Participants have a normal cervical ThinPrep® cytologic test, (TCT) or Pap smear within 12 months of Screening. If not available, a cervical smear will be performed as part of screening
* Other protocol defined criteria may apply
Exclusion Criteria:
* Participants with history of severe OHSS in any previous ovarian stimulation cycle
* Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modified definition
* Participants with contraindication to treatment with gonadotropins, hypersensitivity to gonadotropins or to any of the excipients
* Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, or mammary carcinoma)
* Participants with ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 millimeters before Day 1
* other protocol defined exclusion criteria may apply
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
42 Years
Study:
NCT07340827
Study Brief:
Protocol Section:
NCT07340827