Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

Prospective, Open-label, Uncontrolled Clinical Trial Evaluating Multiple Controlled Ovarian Hyperstimulation Cycles in Oocyte Donor, to Assess the Immunogenicity of FSH-IBSA

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.

Study Overview

• Status: Completed
• Conditions: Oocyte Donation
• Intervention / Treatment: Drug: FSH (Follicle Stimulating Hormone)

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 8028
    • Dep.Obstet-Gynec.-Reproduction,Institut Universitari Dexeus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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…).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FSH; FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.	Drug: FSH (Follicle Stimulating Hormone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Producing Anti-FSH Antibodies.	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.	4 months.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IBSA Institut Biochimique SA

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: February 4, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Hormones
• Other Study ID Numbers: 11E/FSH03