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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT04178135
Eligibility Criteria:
Inclusion Criteria:
1.Infertile women, 35≤ Age\< 40 years 2.18\<BMI\<28 Kg/m2 3.5 ≤AFC ≤20 4.Basal serum FSH≤10 IU/L, E2\<70 pg/ml 5.Previous cycle as the first COS cycle,AFC ≥ 5,starting dose of FSH between 150 IU and 300IU with the possibility of adding r-hLH or hMG later in the cycle, number of oocytes retrieved ≤9 (4-9 oocytes retrieval as suboptimal responder and \<4 oocytes retrieval as unexpected poor responder), but not get live birth after all embryos were used.
6.Normal uterus and at least one side of the normal ovary 7.GnRH-a long protocol, using Gonal-F® 300IU and Luveris® 150IU for COS 8.Informed consent form signed 9.Willing to follow the study protocol, and able to complete this study
Exclusion Criteria:
1. Moderate and Severe endometriosis
2. PCOS
3. Previous ovarian surgery history
4. History of recurrent miscarriages (\>2 times of miscarriages)
5. Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
6. With pregnancy contraindications Alcoholism, drug abuse, drug addiction or patients with uncured sexually transmitted disease
7. According to the judgment of the Investigator, any medical condition or any concomitant surgery/medications that would interfere with evaluation of study medications
8. Simultaneous participation in another clinical study
9. Plan to use other Gn other than Gonal-F® or Luveris® during COS treatment Thyroid gland disorders
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Months
Maximum Age:
40 Years
Study:
NCT04178135
Study Brief:
Protocol Section:
NCT04178135