Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

IBSA

Status and phase

Completed

Phase 3

Conditions

Oocyte Donation

Treatments

Drug: FSH (Follicle Stimulating Hormone)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01785095

11E/FSH03

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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...).