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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 9, 2017
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

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.

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: FSH
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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Total Dose of FSH Units Used. [ Time Frame: after 2 weeks of treatment ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 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…).

Information from the National Library of Medicine

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


Locations
Spain
Dep.Obstet-Gynec.-Reproduction,Institut Universitari Dexeus
Barcelona, Spain, 8028
Sponsors and Collaborators
IBSA Institut Biochimique SA

Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT01785095     History of Changes
Other Study ID Numbers: 11E/FSH03
First Posted: February 7, 2013    Key Record Dates
Results First Posted: March 27, 2015
Last Update Posted: February 9, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs