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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.).

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

Details

• Lead Sponsor: IBSA Institut Biochimique SA

Criteria

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.