Clinical trial NCT00335894: Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).
Official title: A Prospective, Randomized, Investigator-blind, Controlled, Clinical Study of Phase III on the Efficacy and Tolerability of hMG-IBSA (IBSA) vs Menopur (Ferring) Administered s.c. in Women Undergoing COH in an ART Programme (IVF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: Infertility
IVF
ART
hMG
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2006-06-12
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: total number of oocytes retrieved 34 - 36 hours after hCG administration.
Secondary outcomes:
measure: 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.
measure: number of mature oocytes and inseminated oocytes; fertilization rate.
measure: embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate
measure: Tolerability evaluation
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Università degli Studi di Bologna
city: Napoli
country: Italy
facility: Università degli Studi di Napoli Federico II
Study officials:
affiliation: Federico II University
name: Giuseppe De Placido, Prof
role: STUDY_DIRECTOR
References:
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