Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

Infertility; Oocytes Donation; Immunogenicity. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785095
• Other study ID #: 11E/FSH03
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2013
• Last updated: March 23, 2015
• Start date: March 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility; Oocytes Donation; Immunogenicity.

Intervention

Drug:
• FSH (Follicle Stimulating Hormone)

Locations

Country	Name	City	State
Spain	Dep.Obstet-Gynec.-Reproduction,Institut Universitari Dexeus	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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	No
Secondary	Total Dose of FSH Units Used.		after 2 weeks of treatment	No