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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT01785095
Eligibility Criteria:
Inclusion Criteria:
* Healthy female volunteers undergoing controlled ovarian hyperstimulation for oocyte donation with the following characteristics:
* Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;
* \>=18 and \<35 years old;
* Regular menstrual cycle (26 - 35 days);
* BMI between 18 and 30 kg/m2;
* First gonadotrophin treatment (i.e. naïve Subjects with regard to exposure to human derived or recombinant gonadotrophins);
* basal FSH \<10 IU/L and E2 \<80 pg/ml (\~290 pmol/l);
* Normal TSH levels;
* Willing to perform at least two consecutive oocyte retrieval cycles (with a wash out period of two months).
Exclusion Criteria:
* Age \<18 and \>=35 years;
* PCOS;
* Endometriosis;
* Subjects with evidences of autoimmune or rheumatic diseases;
* Hypersensitivity to the active substance or to any of the excipients (lactose);
* Abnormal bleeding of undetermined origin;
* Subject found to be positive to anti-TSH antibodies (i.e. suffering from thyroidal diseases);
* Uncontrolled adrenal dysfunction;
* Neoplasia;
* Severe impairment of renal and/or hepatic function;
* Use of concomitant medications that might interfere with study evaluations (e.g. immunosuppressant, non-study hormonal medications, therapeutics proteins like insulin, growth hormone…).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01785095
Study Brief:
Protocol Section:
NCT01785095