Study to evaluate if the medication taken for inducing the production of eggs, Follicle Stimulating Hormone (FSH), may induce any kind of immune reaction.

• Conditions: Female infertility; MedDRA version: 14.1Level: PTClassification code 10053370Term: Oocyte donationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2012-000269-19-ES
• Lead Sponsor: IBSA, Institute Biochimique S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-29
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Able and willing to sign the Subject Consent Form and adhere to the study visitation 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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?).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified