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:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT06778304
Eligibility Criteria:
Inclusion Criteria:
1. Healthy female participants aged 18-45 years (inclusive).
2. Body weight ≥45 kg, and body mass index (BMI) between 18-28 kg/m² (inclusive), where BMI = weight (kg) / height (m)².
3. Non-pregnant or non-lactating females.
4. Menstrual cycle length between 25-34 days (inclusive).
5. Females with a history of sexual activity but no plans for pregnancy.
6. Liquid-based/thin-layer cytology examination shows no clinically significant abnormalities.
7. Normal sex hormone levels, or abnormalities deemed clinically insignificant by the investigator.
8. Negative test results for HIV, HBV, HCV, or Treponema pallidum (T-trust).
9. Normal or clinically insignificant findings in medical history, physical examination, laboratory tests, and gynecological examinations (e.g., uterus and bilateral ovaries), as judged by the study physician.
10. Willing to participate in this clinical trial, understanding the study procedures, and able to provide written informed consent.
Subjects who do not meet any of the above criteria will not be eligible for participation as volunteers.
Exclusion Criteria:
1. Patients with polycystic ovary syndrome (PCOS).
2. Individuals with a history of FSH allergy, including those who have experienced ovarian hyperstimulation syndrome (OHSS) or are known to be allergic to gonadotropin-releasing hormone agonists (GnRH-a) or their analogs.
3. Individuals with special dietary requirements during hospitalization who cannot adhere to a standardized diet.
4. Individuals with a medical history of ovarian, breast, uterine, hypothalamic, or pituitary diseases deemed clinically significant by the investigator, or a history of thrombosis or current thrombotic disorders.
5. Individuals with diminished ovarian reserve.
6. Individuals engaged in intense physical activities, such as professional athletes.
7. Individuals who have used any prescription drugs or therapeutic medications within 1 week prior to dosing.
8. Individuals using hormonal contraceptives (short-term contraceptives within 3 months before screening or long-term contraceptives within 6 months before screening).
9. Individuals with alcohol abuse (defined as consuming more than 21 standard units of alcohol per week, where 1 standard unit contains 14 g of alcohol, e.g., 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine) or frequent alcohol consumption within 6 months before screening (defined as consuming more than 14 standard units per week, e.g., 240 mL of beer, 30 mL of 40% spirits, or 100 mL of wine) or alcohol consumption within 24 hours before dosing.
10. Individuals who are heavy smokers (smoking more than 5 cigarettes per day within 3 months before the trial) or cannot comply with the smoking ban during the trial.
11. Individuals with a history of drug abuse (e.g., morphine, methamphetamine, ketamine, MDMA, THC, etc.).
12. Individuals who consume strong coffee or tea daily.
13. Individuals who have donated blood or experienced blood loss ≥400 mL within 3 months.
14. Individuals who have participated in any drug clinical trial as a subject within 3 months before this trial.
15. Individuals deemed unsuitable for participation by the investigator.
Exclusion:
Subjects who meet any of the above criteria will not be eligible for participation.
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Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06778304
Study Brief:
Protocol Section:
NCT06778304