Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

Phase 3

Completed

• Conditions: Oocyte Donation
• Interventions: Drug: FSH (Follicle Stimulating Hormone)

• Registration Number: NCT01785095
• Lead Sponsor: IBSA Institut Biochimique SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-07
• Study Start: 2013-03
• Primary Completion: 2014-07
• Study Completion: 2014-11
• Results First Submitted: 2015-02-12
• Results First Submitted QC: 2015-03-23
• Results First Posted: 2015-03-27
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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).

Read More

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...).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Patients Producing Anti-FSH Antibodies.	4 months.	The immunogenicity potential of FSH in healthy volunteer will be assessed by analysing serum samples collected at different timepoints during two treatment cycle for oocytes donation: cycle 1, serum samples will be collected before treatment start (baseline), after 7-13 days and after 28 days of treatment; Cycle 2: serum samples will be collected before starting the second cycle (baseline 2), after 7-13 days and after 28 days of treatment. Cycle 1 and cycle 2 will be separated by a wash-out period of two months.

Secondary Outcome Measures

Name	Time	Method
Number of Oocytes Retrieved	after 2 weeks of treatment	the number of oocytes retrieved in the first cycle and in the second cycle are compared.
Total Dose of FSH Units Used.	after 2 weeks of treatment

Trial Locations

Locations (1)

Dep.Obstet-Gynec.-Reproduction,Institut Universitari Dexeus; 🇪🇸 Barcelona, Spain