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 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT03457233
Eligibility Criteria:
Inclusion Criteria:
* 4- Poor responder according to ESHRE consensus; in which at least 2 of the following should be present: Advanced maternal age (≥ 40 years old) or any other risk factor A previous poor ovarian response (cycles cancelled or ≤ 3 oocytes with a conventional protocol)An abnormal ovarian reserve test (ORT); antral follicle count (AFC) \< 5-7 follicles or anti-mullerian hormone (AMH) ≤0.5- 1.1 ng/ml In the absence of advanced maternal age or abnormal ORT, two previous episodes of poor ovarian response after maximal stimulation patients are also considered poor responders according to ESHRE consensus.
Presence and Adequate visualization of both ovaries Uterine cavity within normal anatomy assessed with HSG, hysteroscopy and TVUS
Exclusion Criteria:
Any factor which may affect reproductive outcome other than that the patient is a poor responder will be excluded from the study, like:
1. Severe male factor .
2. Uterine factor (eg: fibroid, polyp, Ashermann, .. etc)
3. Immunological disorder (eg: SLE, APS, … etc)
4. Thyroid or adrenal dysfunction
5. Neoplasia (especially: hypothalamic, pit, ovarian)
6. Women diagnosed with PCOS according to Rotterdam criteria
7. Hydrosalpinx that hasn't been surgically removed or ligated.
8. Untreated hyperprolactinemia
9. Abnormal bleeding disorder
10. Hepatic or renal dysfunction
11. Hypersenstivity to study medication ( GNRH antagonist)
12. Need to take medication that can influence ovarian stimulation
13. Endometriosis grade 3 or 4
14. Ovarian cyst\> 10 cm.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
44 Years
Study:
NCT03457233
Study Brief:
Protocol Section:
NCT03457233