FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)

Study Overview
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Brief Summary
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The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.

Official Title
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Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.

Conditions
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Infertility

Intervention / Treatment
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* Drug: Urofollitrophin
* Drug: Follitrophin alpha


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-38 years old; BMI: 18-28 kg/m2; Less than 3 previously completed IVF cycles; Basal FSH <10 IU/L and E2 <80 pg/ml; TSH < 2.5 mIU/L >10 and <30 antral follicles 2-10 mm in size for both ovaries combined AMH: >1 ng/ml (7.15 pmol/l) and <5.6 ng/ml (40.0 pmol/l) Presence and adequate visualization of both ovaries; Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination; Exclusion Criteria: Primary ovarian failure or women known as poor responders; PCO and PCOS; Severe OHSS in a previous COH cycle; Uterine malformation that may impair the possibility to get pregnant; Ovarian cysts >10 mm; Hydrosalpinx that have not been surgically removed or ligated; Endometriosis stage 3 or 4; Oocyte donation; Severe male factor; Pathologies associated with any contraindication of being pregnant; History of recurrent miscarriage (more than 3 previous miscarriages); Hypersensitivity to the study medication; Abnormal bleeding of undetermined origin; Uncontrolled thyroid or adrenal dysfunction; Neoplasias; Severe impairment of renal and/or hepatic function.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fostimon®<br>75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) | Drug: Urofollitrophin<br> <br> * Other names: human derived follicle stimulation hormone;|
| Active Comparator: Gonal-F®<br>75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) | Drug: Follitrophin alpha<br> <br> * Other names: Recombinant follicle stimulation hormone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rate | A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation; | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Follicles >16 mm on the Day of hCG Injection |  | 10-15 days after starting FSH stimulation | 
| Total Number of Oocytes Retrieved |  | end of treatment period, approximately 2 - 3 weeks. | 
| Fertilization Rate |  | end of treatment period, approximately 2 - 3 weeks | 
| Embryo Quality (Number of Top Quality Embryos Transferred Per Patient) | The embryo quality evaluation will be performed on culture day 3, just before embryo transfer and will consist in the assessment of blastomeres number and 2 embryo morphology parameters: degree of fragmentation and cell division aspect. | On culture day 3 | 
| Positive Serum Pregnancy Test Rate | Two weeks after embryo transfer, a serum pregnancy test will be performed. | 2 weeks after embryo transfer | 
| Delivery Rate |  | 9 months | 
| Cumulative Pregnancy Rate | Patients who will not get pregnant during the study, will be allowed to perform a frozen embryo transfer. Cumulative pregnancy rate will include also pregnancies achieved after a frozen embryo transfer. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In vitro fertilization (IVF), Assisted reproduction technologies (ART), GnRH-antagonist, Follicle stimulating hormone (FSH)