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MENOPUR in GnRH Antagonist Cycles With Single Embryo Transfer (MEGASET)
This study is not yet open for participant recruitment.
Verified by Ferring Pharmaceuticals, April 2009
First Received: April 17, 2009   Last Updated: July 3, 2009   History of Changes
Sponsored by: Ferring Pharmaceuticals
Information provided by: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00884221
  Purpose

The main purpose of this clinical research trial is to compare the pregnancy rate between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant FSH), in cycles where a GnRH antagonist is used for prevention of premature LH surge.


Condition Intervention Phase
Infertility
 Drug: Menotrophin
Drug: Follitrophin-beta
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: A Randomised, Open-Label, Assessor-Blind, Parallel Groups, Multicentre Trial Comparing the Efficacy of MENOPUR Versus Recombinant FSH in Controlled Ovarian Stimulation Following a GnRH Antagonist Protocol and Single Embryo Transfer

Resource links provided by NLM:

MedlinePlus related topics: Infertility
Drug Information available for: Menotropins
U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Ongoing Pregnancy [ Time Frame: 12-15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endocrine profile [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Follicular development [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Embryo quality [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 660
Arms Assigned Interventions
1: Experimental Drug: Menotrophin
2: Active Comparator Drug: Follitrophin-beta

  Eligibility

Ages Eligible for Study:   21 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects should be 21-34 years old, have early follicular FSH levels between 1 and 12 IU/L and antral follicle count ≥ 10, regular menstrual cycles of 24-35 days presumed to be ovulatory, as well as having been infertile for at least 12 months.

Exclusion Criteria:

  • Subjects with known polycystic ovarian syndrome, known endometriosis stage I-IV or diagnosed as poor responders will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884221

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

Locations
Belgium
ERASME Hospital
Anderlecht, Belgium
UZ Brussel
Brussels, Belgium
UZ Gent
Gent, Belgium
Czech Republic
Plzen
Plzen, Czech Republic
ISCARE IVF a.s.
Prague, Czech Republic
Pronatal
Prague, Czech Republic
Denmark
Sygehus Vestsjælland
Holbæk, Denmark
H:S Hvidovre Hospital
Hvidovre, Denmark
H:S Rigshospitalet
København, Denmark
Poland
KRIOBANK
Bialystok, Poland
nOvum
Warszawa, Poland
Spain
IU Dexeus
Barcelona, Spain
IVI Madrid
Madrid, Spain
GINEFIV, Madrid
Madrid, Spain
IVI Sevilla
Sevilla, Spain
Ginemed
Sevilla, Spain
IVI Valencia
Valencia, Spain
Sweden
Sahlgrenska
Stockholm, Sweden
Fertilitetscentrum AB Göteborg
Göteborg, Sweden
IVF-kliniken CURA
Malmö, Sweden
RMC, Malmö
Malmö, Sweden
Turkey
Zekai Tahir Burak Hospital
Ankara, Turkey
Ege University
Izmir, Turkey
Hacettepe University
Ankara, Turkey
American Hospital
Istanbul, Turkey
Memorial Hospital
Istanbul, Turkey
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers: FE999906 CS08, EudraCT Number: 2008-006775-67
Study First Received: April 17, 2009
Last Updated: July 3, 2009
ClinicalTrials.gov Identifier: NCT00884221     History of Changes
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products;   Belgium: Institutional Review Board;   Czech Republic: Ethics Committee;   Czech Republic: State Institute for Drug Control;   Denmark: Danish Medicines Agency;   Denmark: Ethics Committee;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   Spain: Ethics Committee;   Spain: Spanish Agency of Medicines;   Sweden: Medical Products Agency;   Sweden: Regional Ethical Review Board;   Turkey: Ethics Committee;   Turkey: Ministry of Health

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Menotropins
Genital Diseases, Male

Additional relevant MeSH terms:
Genital Diseases, Female
Infertility
Therapeutic Uses
Fertility Agents, Female
Physiological Effects of Drugs
 Fertility Agents
Menotropins
Reproductive Control Agents
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 24, 2009



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