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Study to evaluate if the medication taken for inducing the production of eggs, Follicle Stimulating Hormone (FSH), may induce any kind of immune reaction.

Prospective, open-label, uncontrolled clinical trial evaluating multiple controlled ovarian hyperstimulation cycles in oocyte donor, to assess the immunogenicity of FSH-IBSA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000269-19-ES
Enrollment
Unknown
Registered
2012-10-29
Start date
2012-12-20
Completion date
Unknown
Last updated
2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female infertility MedDRA version: 14.1 Level: PT Classification code 10053370 Term: Oocyte donation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Fostimon Fostipur Product Name: Fostipur/FSH IBSA Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Urofollitropin CAS Number: 97048-13-0 Current Spon

Sponsors

IBSA, Institute Biochimique S.A.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Able and willing to sign the Subject Consent Form and adhere to the study visitation schedule; ->=18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Age = 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?).

Design outcomes

Primary

MeasureTime frame
Main Objective: The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing COH in an oocyte donation program.;Secondary Objective: Not applicable;Primary end point(s): To test the production of anti-FSH antibodies (IgG, IgM, and IgA) using a sensitive screening assay.;Timepoint(s) of evaluation of this end point: A serum sample will be collected for anti-FSH antibodies detection at visit 2, 3, 4, 5, 6, 7—

Secondary

MeasureTime frame
Secondary end point(s): In case anti-FSH antibodies are detected: - To determine whether the antibodies detected are neutralising in a bioassay. - To determine whether the antibodies that are induced by the product cross-react with their endogenous counterpart or with other hormones that share the common alpha chain with FSH (LH, TSH).;Timepoint(s) of evaluation of this end point: At visit 2, 3, 4, 5, 6, 7 if anti-FSH are detected—

Countries

Spain

Contacts

Public ContactClinical Research Manager

IBSA, Institute Biochimique

barbara.cometti@ibsa.ch+41583601000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026