Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

Study Overview
=================
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.

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

Conditions
-----------------
Oocyte Donation

Intervention / Treatment
-----------------
* Drug: FSH (Follicle Stimulating Hormone)


Participation Criteria
=================
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 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…).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FSH<br>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)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Total Dose of FSH Units Used. |  | after 2 weeks of treatment |