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

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ClinicalTrials.gov Identifier: NCT00335894
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : March 10, 2010
Sponsor:
Information provided by:
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.).

Condition or disease Intervention/treatment Phase
Infertility Drug: hMG-IBSA Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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 Start Date : May 2005
Actual Primary Completion Date : May 2008
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility




Primary Outcome Measures :
  1. total number of oocytes retrieved 34 - 36 hours after hCG administration.

Secondary Outcome Measures :
  1. 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.
  2. number of mature oocytes and inseminated oocytes; fertilization rate.
  3. embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate
  4. Tolerability evaluation


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335894


Locations
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Italy
Università degli Studi di Bologna
Bologna, Italy, 40138
Università degli Studi di Napoli Federico II
Napoli, Italy, 80131
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
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Study Director: Giuseppe De Placido, Prof Federico II University

Publications:

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ClinicalTrials.gov Identifier: NCT00335894     History of Changes
Other Study ID Numbers: 04I/HMG10
First Posted: June 12, 2006    Key Record Dates
Last Update Posted: March 10, 2010
Last Verified: December 2008
Keywords provided by IBSA Institut Biochimique SA:
Infertility
IVF
ART
hMG
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs