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:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT06864793
Eligibility Criteria:
Inclusion Criteria:
* Female, Age between 18 to 45 years (inclusive).
* Body mass index (BMI) of ≥18 and ≤28 kg/m2, body weight ≥45 kg.
* With a history of sexual activity
* Regular menstruation cycle (25 to 35 days, inclusive).
* Normal sex hormone levels, or abnormalities deemed clinically insignificant by the investigator.
* Reached the standard within the time window after receiving the down-regulated drug.
* Agreed to take effective contraceptive measures during and 6 months after the end of the study period.
* Willing to participate in this clinical trial, understanding the study procedures, and able to provide written informed consent.
Exclusion Criteria:
* History of ovarian hyperstimulation syndrome, or polycystic ovary syndrome, or ovarian enlargement or cysts not caused by polycystic ovary syndrome, or primary ovarian failure; history of hypothalamic or pituitary tumors; history of malignancy; History of thrombosis; or other diseases that considered to influence the study by the investigator.
* Unexplained reproductive tract bleeding.
* Thin-layer cytology examination deemed clinically significant by the investigator.
* Vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator with.
* Pregnancy or lactation period, or positive human chorionic gonadotropin (HCG) examination.
* Known to be allergic to follicle-stimulating hormone (FSH), or gonadotropin-releasing hormone agonists (GnRH-a) or their analogs
* Consume strong coffee or tea daily
* Historic abuse of alcoholic beverages
* Smoke ≥5 cigarettes per day within 3 months prior to the study
* History of drug abuse
* Unsuitable for participation by the investigator.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06864793
Study Brief:
Protocol Section:
NCT06864793