Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

NCT01785095 | Completed Phase 3 Results

• 1 other identifier: 11E/FSH03
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Oocytes Retrieved

  after 2 weeks of treatment

• Total Dose of FSH Units Used.

  after 2 weeks of treatment

Study Arms (1)

FSH

EXPERIMENTAL

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)

Interventions

FSH (Follicle Stimulating Hormone) DRUG

FSH

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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…).

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (1)

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

Barcelona, 8028, Spain

Location

MeSH Terms

Interventions

Follicle Stimulating Hormone, Human

Intervention Hierarchy (Ancestors)

Follicle Stimulating Hormone; Gonadotropins, Pituitary; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: IBSA Clinical Research Manager
• Organization: IBSA Institut Biochimique SA

rd@ibsa.com

+41583601000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: February 7, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 9, 2017
• Results First Posted: March 27, 2015

Record last verified: 2016-12

Locations

ES (1)