Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).

Study Overview
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Brief Summary
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Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and the other the reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.).

Detailed Description
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The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopur, Ferring Pharmaceuticals, Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.

Official Title
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A Prospective, Randomized, Investigator-blind, Controlled, Clinical Study of Phase III on the Efficacy and Tolerability of hMG-IBSA (IBSA) vs Menopur (Ferring) Administered s.c. in Women Undergoing COH in an ART Programme (IVF)

Conditions
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Infertility

Intervention / Treatment
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* Drug: hMG-IBSA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing ovarian stimulation for IVF with or without ICSI (intracytoplasmic sperm injection) and with the following characteristics: Voluntary given informed consent to study participation in writing encompassing consent to data recording and verification procedures; > 18/= and < 37 years old; BMI between 18 and 28 kg/m2; Less than 3 previous completed IVF cycles; Basal FSH level less than 10 IU/L once within 6 months prior to the study; Within 12 month of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, or sonohysterogram, or hysteroscopic examination or TVUS; Normal or clinically insignificant haematology and blood chemistry values. Exclusion Criteria: Primary ovarian failure or women known as poor responders; Signs of PCO, according to the Rotterdam Criteria; At least one ovary inaccessible for oocyte retrieval; One or more ovarian cysts > 10 mm; Hydrosalpinx that have not been surgically removed or ligated; Stage III or IV endometriosis; Patients affected by pathologies associated with any contraindication of being pregnant; Hypersensitivity to the study medication; Abnormal bleeding of undetermined origin; Uncontrolled thyroid or adrenal dysfunction; Neoplasias; PAP smear III within the last 2 years; Severe impairment of the renal and/or hepatic functions; Lactation; Hyperprolactinaemia; Participation in a concurrent clinical trial or in another trial within the past four weeks; Use of concomitant medication that might interfere with study evaluations.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 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

| Intervention/Treatment |
| --- |
|Drug: hMG-IBSA|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total number of oocytes retrieved 34 - 36 hours after hCG administration. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of hMG (IU); number of days of hMG stimulation and stimulation duration; cancellation rate with reasons; 17β-estradiol (E2) serum concentration; number of follicles >16 mm. |  |  | 
| number of mature oocytes and inseminated oocytes; fertilization rate. |  |  | 
| embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate |  |  | 
| Tolerability evaluation |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, IVF, ART, hMG