Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

NCT ID: NCT01785095

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-11-30

Brief 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.

Conditions

Oocyte Donation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FSH

FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.

Group Type: EXPERIMENTAL

FSH (Follicle Stimulating Hormone)

Intervention Type: DRUG

Interventions

FSH (Follicle Stimulating Hormone)

Intervention Type: DRUG

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…).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

IBSA Institut Biochimique SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dep.Obstet-Gynec.-Reproduction,Institut Universitari Dexeus

Barcelona, , Spain

Countries

Spain

Other Identifiers

11E/FSH03

Identifier Type: -

Identifier Source: org_study_id