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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01081756
Eligibility Criteria:
Inclusion Criteria:
* Infertility regular ovulatory menstrual cycles;
* Early luteal phase serum levels:
* FSH≤ 10IU/l
* LH≤ 10IU/l
* PRL≤ 30ng/ml
* T≤ 50pg/ml
* Haematology, blood chemistry, urinalysis normal
* Both ovaries present
* \< 3 previous ART cycles, no ART cycles for 2 menstrual cycles
Exclusion Criteria:
* With a poor response to gonadotrophin stimulation, such as ≤3 oocytes collected in any previous IVF cycle
* Any medical condition may interfere with the absorption, distribution, metabolism or excretion of the drug.
* Had previous severe ovarian hyperstimulation syndrome(OHSS)
* A body mass index (BMI) \>25 kg/m2
* Any contraindication to being pregnant and/or carrying a pregnancy to term
* Extra-uterine pregnancy within the last 3 months
* A clinically significant systemic disease
* Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus
* Abnormal gynaecological bleeding of undetermined origin
* Known allergy or hypersensitivity to human gonadotrophin preparations
* Simultaneous participation in another clinical trial
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT01081756
Study Brief:
Protocol Section:
NCT01081756