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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT04878705
Eligibility Criteria:
Inclusion Criteria:
* Body weight ≥ 45 kg, 19 ≤ body mass index (BMI) ≤ 28 kg /m2;
* Women with sexual experience, potential fertility and regular menstrual cycle (25-34 days) (including boundary value);
* The levels of sex hormones were normal or abnormal without clinical significance at the time of screening;
* The physiological structure of uterus and bilateral ovaries was normal or abnormal by ultrasound examination, without clinical significance;
Exclusion Criteria:
* Known the history of stage III / IV endometriosis, submucosal myoma and endocrine abnormality within 6 months before enrollment;
* Known the history of ovarian hyperstimulation syndrome (OHSS);
* Premature ovarian failure, decreased ovarian reserve function (Antral Follicle Counting \< 3), high ovarian response, polycystic ovary syndrome, unexplained vaginal bleeding or endometrial hyperplasia;
* Any FSH or HMG preparations were used within 3 months before the first study;
* Pregnancy or lactating women.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
42 Years
Study:
NCT04878705
Study Brief:
Protocol Section:
NCT04878705