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

Phase 3

Completed

• Conditions: Infertility

• Registration Number: NCT00335894
• Lead Sponsor: IBSA Institut Biochimique SA

Brief 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.).

Detailed Description

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-06-09
• Study First Submitted QC: 2006-06-09
• Study First Posted: 2006-06-12
• Primary Completion: 2008-05
• Status Verified: 2008-12
• Study Completion: 2009-03
• Last Update Submitted: 2010-03-09
• Last Update Posted: 2010-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
total number of oocytes retrieved 34 - 36 hours after hCG administration.

Secondary Outcome Measures

Name	Time	Method
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.
Tolerability evaluation
number of mature oocytes and inseminated oocytes; fertilization rate.
embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate

Trial Locations

Locations (2)

Università degli Studi di Bologna; 🇮🇹 Bologna, Italy

Università degli Studi di Napoli Federico II; 🇮🇹 Napoli, Italy