Phase 3
N=27
Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles
Oocyte Donation
Bottom Line
View on ClinicalTrials.gov: NCT01785095 ↗Enrolled (actual)
27
Serious AEs
3.7%
Results posted
Mar 2015
Primary outcome: Primary: Number of Patients Producing Anti-FSH Antibodies. — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FSH (Follicle Stimulating Hormone) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- IBSA Institut Biochimique SA
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Producing Anti-FSH Antibodies. |
— | — |
| SECONDARY Number of Oocytes Retrieved |
13.4; 15.7 | — |
| SECONDARY Total Dose of FSH Units Used. |
1911.1; 1984.4 | — |
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.
Eligibility Criteria
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;
- 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…).
Data sourced from ClinicalTrials.gov (NCT01785095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.