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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00335894
Eligibility Criteria:
Inclusion Criteria:
* Women undergoing ovarian stimulation for IVF with or without ICSI (intracytoplasmic sperm injection) and with the following characteristics:
* Voluntary given informed consent to study participation in writing encompassing consent to data recording and verification procedures;
* \> 18/= and \< 37 years old;
* BMI between 18 and 28 kg/m2;
* Less than 3 previous completed IVF cycles;
* Basal FSH level less than 10 IU/L once within 6 months prior to the study;
* Within 12 month of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, or sonohysterogram, or hysteroscopic examination or TVUS;
* Normal or clinically insignificant haematology and blood chemistry values.
Exclusion Criteria:
* Primary ovarian failure or women known as poor responders;
* Signs of PCO, according to the Rotterdam Criteria;
* At least one ovary inaccessible for oocyte retrieval;
* One or more ovarian cysts \> 10 mm;
* Hydrosalpinx that have not been surgically removed or ligated;
* Stage III or IV endometriosis;
* Patients affected by pathologies associated with any contraindication of being pregnant;
* Hypersensitivity to the study medication;
* Abnormal bleeding of undetermined origin;
* Uncontrolled thyroid or adrenal dysfunction;
* Neoplasias;
* PAP smear III within the last 2 years;
* Severe impairment of the renal and/or hepatic functions;
* Lactation;
* Hyperprolactinaemia;
* Participation in a concurrent clinical trial or in another trial within the past four weeks;
* Use of concomitant medication that might interfere with study evaluations.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
36 Years
Study:
NCT00335894
Study Brief:
Protocol Section:
NCT00335894