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 @ 4:22 PM
Ignite Modification Date:
2025-12-24 @ 4:22 PM
NCT ID:
NCT01312766
Eligibility Criteria:
Inclusion Criteria:
* Women undergoing ovarian stimulation for IVF with the following characteristics:
* Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule
* \>18 and \<40 years old
* BMI between 18 and 30 kg/m2
* less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery)
* basal FSH \<10 IU/L and E2 \<80 pg/ml (\~290 pmol/l)
* Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination
* Successful down-regulation performed with a standard GnRH-Agonist long protocol (Criteria for successful down-regulation: endometrial thickness \< 7mm or serum E2 level \<50 pg/ml (\~185 pmol/l).
Exclusion Criteria:
* age \<18 and \>40 years
* primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration \<500pg/ml (\~1800 pmol/l))
* PCOS
* one or both ovaries inaccessible for oocyte retrieval
* ovarian cysts \>10 mm
* hydrosalpinx that have not been surgically removed or ligated;
* stage 3 or 4 endometriosis
* oocyte donation
* implantation of previously frozen embryos
* 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
* severe impairment of renal and/or hepatic function
* use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01312766
Study Brief:
Protocol Section:
NCT01312766