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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IBSA Institut Biochimique SA
• Treatments: Menotropins

Criteria

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)