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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT00702351
Eligibility Criteria:
Inclusion Criteria:
* Females of couples with an indication for controlled ovarian stimulation (COS) and IVF or ICSI that have had at least one previous COS cycle with proven normal ovarian response;
* \>=18 and \<= 39 years of age at the time of signing informed consent;
* a. First group: Body weight \>= 50 kg and BMI \>= 18 and \<= 29 kg/m\^2; b. Second group: Body weight \<= 60 kg and BMI \<= 29 kg/m\^2;
* Normal menstrual cycle length: 24-35 days;
* Ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
* Normal routine diagnostic hysteroscopy and endometrial biopsy;
* Willing and able to sign informed consent.
Exclusion Criteria:
* History of or any current (treated) endocrine abnormality;
* History of ovarian hyper-response1 or history of ovarian hyperstimulation
syndrome (OHSS);
* History of or current polycystic ovary syndrome (PCOS);
* A basal antral follicle count \> 20 (size \< 11 mm, both ovaries combined) on USS during the early follicular phase (menstrual cycle day 2-5);
* Less than 2 ovaries or any other ovarian abnormality;
* Presence of unilateral or bilateral hydrosalpinx (visible on USS);
* Presence of unilateral or bilateral endometriomas (\>10 mm; visible on USS);
* More than three unsuccessful COS cycles since the last established ongoing
pregnancy (if applicable);
* History of non- or low ovarian response to FSH/hMG treatment;
* FSH or LH \> 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
* Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
* Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH analogues (e.g. hypersensitivity, pregnancy/lactation);
* Recent history of or current epilepsy, diabetes or cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
* History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
* Previous use of Org 36286;
* Use of hormonal preparations within 1 month prior to screening;
* Administration of investigational drugs within three months prior to signing
informed consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT00702351
Study Brief:
Protocol Section:
NCT00702351