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Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.

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ClinicalTrials.gov Identifier: NCT00335725
Recruitment Status : Completed
First Posted : June 12, 2006
Results First Posted : March 27, 2015
Last Update Posted : March 27, 2015
Sponsor:
Information provided by:
IBSA Institut Biochimique SA

Brief Summary:
Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs Gonal-F® Serono) when administered in patients undergoing ICSI

Condition or disease Intervention/treatment Phase
Infertility Drug: Follicle Stimulating Hormone Phase 3

Detailed Description:

This is a multicentric, prospective, randomised, investigator blind, controlled clinical trial (phase III) of two parallel groups, one receiving the test drug FSH (Fostimon® , IBSA) and the other the reference drug FSH (Gonal-F®, Serono). The groups will be paired on the major prognostic criteria.

In effect, a double blind trial is not really feasible since the drugs presentations are very different. However, in IVF, drugs are usually dispensed and/or injected by a nurse and therefor the Investigator can be blind. Moreover, the used preparations will contain the same amount of gonadotrophin units (75 IU), will be repackaged in anonymous boxes and the following sentence will be written in the Patient Information Sheet: "You are required not to inform the Investigator about the product's name".

The randomisation is necessary to get groups as comparable as possible for all the other aspects. The multicentric design has the double interest of facilitating the patients' recruitment and of decreasing the biases related to attitudes in a specific centre.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Multicentric Prospective, Randomised, Controlled Clinical Study on Clinical Efficacy and Tolerability of Urinary FSH (Fostimon® , IBSA) Versus r-FSH (Gonal-F®, Serono) in ICSI.
Study Start Date : March 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Fostimon
Fostimon is an highly purified FSH preparation.
Drug: Follicle Stimulating Hormone
subcutaneous injection of FSH. Starting dose: 225 IU.
Other Name: highly purified human derived FSH; Fostimon

Active Comparator: Gonal-F
Gonal-F is a recombinant FSH preparation.
Drug: Follicle Stimulating Hormone
subcutaneous injection of FSH. Starting dose: 225 IU.
Other Name: rec FSH; Gonal F




Primary Outcome Measures :
  1. Total Number of Oocytes Retrieved [ Time Frame: 10 days after stimulation start ]
    Total number of oocytes retrieved


Secondary Outcome Measures :
  1. Clinical Pregnancy Rate [ Time Frame: 6 weeks after treatment start ]
    clinical pregnancy rate defined as the presence of gestation sac and heart beat.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women undergoing ovarian stimulation for IntraCytoplasmic Sperm Injection (ICSI) with the following characteristics:

>/= 18 and < 40 years old BMI between 19 and 30 kg/m2 less than 3 previous completed cycles basal FSH level less than 10 IU/l within the 6 months prior to the study

Exclusion Criteria:

age < 18 and >/= 40 years primary ovarian failure or women known as poor responders, i.e. requiring more than 225 IU of FSH as starting dose in previous treatment cycles or having less than 3 oocytes retrieved or with an oestradiol serum concentration < 900 pmol/l (250 pg/ml) ovarian cysts > 20 mm oocyte donation thawed embryos replacement patients affected by pathologies associated with any contraindication of being pregnant ascertained or presumptive hypersensitivity to the active principle and/or their ingredients abnormal bleeding of undetermined origin uncontrolled thyroid or adrenal dysfunction neoplasias severe impairment of the renal and/or hepatic functions women deprived of their freedom by administrative or legal decision


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): NCT00335725


Locations
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France
Private Consulting
Bron, France
Hôpital Jeanne de Flandre
Lille, France
Hôpital Edouard Herriot
Lyon, France
Institut de Médecine de la Reproduction
Marseille, France
Hôpital Américain
Neuilly sur Seine, France
Hôpital Tenon
Paris, France
Hungary
Semmelweis Medical School
Budapest, Hungary
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
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Principal Investigator: J G Grudzinskas, Prof The Bridge Centre One St Thomas Street London Bridge London SE1 9RY, UK2.

Publications:

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ClinicalTrials.gov Identifier: NCT00335725     History of Changes
Other Study ID Numbers: 01GBF/FSH08
First Posted: June 12, 2006    Key Record Dates
Results First Posted: March 27, 2015
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by IBSA Institut Biochimique SA:
Ovarian stimulation
Infertility
ICSI
FSH

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs