Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation program.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: IBSA Institut Biochimique SA
• Treatments: Follicle Stimulating Hormone; Hormones

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…).