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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT00713869
Eligibility Criteria:
Inclusion Criteria:
To be eligible for inclusion into this study, each subject must satisfy the following criteria:
1. Infertile woman wishing to conceive and whose physician has recommended that she undergo IVF.
2. Participants must be aged 21 to 35 years
3. Body mass index (BMI) \< 38.
4. Serum results for cycle day 3 FSH \<10 mIU/ml.
5. Must have male partner whose semen analysis meets the clinic criteria for ICSI. Use of donor sperm is also acceptable.
6. Be willing and able to comply with the protocol for the duration of the study.
7. Have voluntarily provided written informed consent under WIRB, prior to any study-related procedure that is not part of normal medical care, with the understanding that the subjects may withdraw consent before they start Lupron without prejudice to their future medical care.
Exclusion Criteria:
A patient may NOT be entered into the study if she presents with ANY of the following criteria:
1. Clinically significant systemic disease.
2. Known endometriosis Grade III - IV (ASRM classification).
3. Any previous cycle indicating a low response to gonadotropin stimulation (defined as retrieval of \< 10 eggs at retrieval)
4. Three or more previous ART cycles without a clinical pregnancy
5. Abnormal, undiagnosed, gynecological bleeding.
6. Previous ovarian surgery
7. Known allergy or hypersensitivity to recombinant gonadotropin preparations or any other study-related medications.
8. Known current substance abuse.
9. Simultaneous participation in another clinical trial.
10. Current smoker.
11. An extrauterine pregnancy within the last 3 months before OCP treatment commences.
12. Previous participation in similar study at different centers.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT00713869
Study Brief:
Protocol Section:
NCT00713869