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:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT00702806
Eligibility Criteria:
Inclusion Criteria:
* Females of couples with an indication for COH and IVF or IVF/ICSI;
* Body mass index (BMI) \>=18 and \<=29 kg/m\^2;
* Normal menstrual cycle length: 24-35 days;
* Ejaculatory sperm;
Exclusion Criteria:
* History of/or current endocrine abnormality such as polycystic ovary syndrome (PCOS), or polycystic ovaries according to ultrasound scan (USS), (treated) hyperprolactinemia or evidence of ovarian dysfunction;
* More than three unsuccessful COH cycles for IVF since the last established ongoing pregnancy (if applicable);
* History of non- or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment;
* Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual Cycle Day 2-7) as measured by the local laboratory (FSH, luteinizing hormone \[LH\], estradiol \[E2\], progesterone \[P\], total testosterone \[T\], thyroid stimulating hormone \[TSH\], and prolactin);
* Any clinically relevant abnormal laboratory value;
* Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
* Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
* Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease;
* History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
* Hypersensitivity to Orgalutran® or any of its components;
* Administration of investigational drugs within three months prior to screening.
* Use of hormonal preparations within one month prior to the start of Org 36286 with the exception of thyroid medication.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT00702806
Study Brief:
Protocol Section:
NCT00702806