Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles
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|ClinicalTrials.gov Identifier: NCT01785095|
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : March 27, 2015
Last Update Posted : February 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Oocyte Donation||Drug: FSH (Follicle Stimulating Hormone)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Open-label, Uncontrolled Clinical Trial Evaluating Multiple Controlled Ovarian Hyperstimulation Cycles in Oocyte Donor, to Assess the Immunogenicity of FSH-IBSA|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||November 2014|
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)
- Number of Patients Producing Anti-FSH Antibodies. [ Time Frame: 4 months. ]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.
- Number of Oocytes Retrieved [ Time Frame: after 2 weeks of treatment ]the number of oocytes retrieved in the first cycle and in the second cycle are compared.
- Total Dose of FSH Units Used. [ Time Frame: after 2 weeks of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785095
|Dep.Obstet-Gynec.-Reproduction,Institut Universitari Dexeus|
|Barcelona, Spain, 8028|