Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients

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 hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.

Official Title
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Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF)

Conditions
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Infertility

Intervention / Treatment
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* Drug: Menotropins
* Drug: Menotropins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing ovarian stimulation for IVF with the following characteristics: Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule >18 and <40 years old BMI between 18 and 30 kg/m2 less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery) basal FSH <10 IU/L and E2 <80 pg/ml ( 290 pmol/l) 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 Successful down-regulation performed with a standard GnRH-Agonist long protocol (Criteria for successful down-regulation: endometrial thickness < 7mm or serum E2 level <50 pg/ml ( 185 pmol/l). Exclusion Criteria: age <18 and >40 years primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration <500pg/ml ( 1800 pmol/l)) PCOS one or both ovaries inaccessible for oocyte retrieval ovarian cysts >10 mm hydrosalpinx that have not been surgically removed or ligated; stage 3 or 4 endometriosis oocyte donation implantation of previously frozen embryos 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 severe impairment of renal and/or hepatic function use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: hMG-IBSA<br>New hMG preparation. | Drug: Menotropins<br>* Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.<br>|
| Active Comparator: Menopur<br> | Drug: Menotropins<br>* Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Oocytes Retrieved |  | up to 24 days after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean hMG Dose (Total); |  | up to 22 days after treatment start | 
| Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo) | Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded. | up to 28 days after treatment start | 
| Positive b-hCG Test |  | up to 5 weeks after treatment start | 
| Controlled Ovarian Stimulation Duration (Days) |  | up to 23 days after treatment start | 
| 17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection; |  | up to 23 days after treatment start | 
| Implantation Rate | defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100; | 10-11 weeks after embryo transfer | 
| Clinical Pregnancy Rate, | defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer; | 10 - 11 weeks after embryo transfer | 
| Number of Mature (Grade III Metaphase II) Oocytes Retrieved. |  | at the end of the stimulation. | 
| Ratio Mature/Total Number of Oocytes Retrieved. | Percentage of retrieved oocytes considered to be mature. | at the end of the stimulation. | 
| Total Number of Inseminated Oocytes (IVF and ICSI) | number of oocytes that were inseminated via IVF or injected via ICSI technique. | on the day of oocyte retrieval | 
| Number of Cleaved Embryos |  | two days after insemination | 
| Live Birth Rate |  | 9 months after treatment |