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
- Patients, with basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l), undergoing controlled ovarian stimulation for in vitro fertilisation.MedDRA version: 12.1Level: LLTClassification code 10056204Term: In vitro fertilisation
- Registration Number
- EUCTR2010-021021-13-HU
- Lead Sponsor
- IBSA, Institut Biochimique S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
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;
• 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of the study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations (hMG-IBSA, IBSA Institut Biochimique SA vs Menopur®, Ferring Pharmaceuticals) when administered to patients undergoing controlled ovarian stimulation for IVF;Secondary Objective: ;Primary end point(s): Total number of oocytes retrieved
- Secondary Outcome Measures
Name Time Method