Meropur Versus rFSH+ rLH in Ovulation Induction Cycles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01604044
First received: May 21, 2012
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

This study evaluate the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.


Condition Intervention Phase
Female Infertility
Drug: Meropur 150 a day
Drug: Gonal-f 150 plus Luveris 150
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Number of stimulation days, number of follicles > 17mm, hyperstimulation [ Time Frame: twenty days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: May 2012
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HP-hMG Drug: Meropur 150 a day
one subcutaneous injection a day
Active Comparator: rFSH plus rLH Drug: Gonal-f 150 plus Luveris 150
one subcutaneous injection a day

  Eligibility

Ages Eligible for Study:   36 Years to 41 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women with story of infertility sine causa and mild-moderate male factor

Exclusion Criteria:

  • tubal occlusion,
  • age < 35 years,
  • PCOS,
  • severe male factor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604044

Locations
Italy
Policlinico Agostino Gemelli
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

No publications provided

Responsible Party: Rosanna Apa, professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01604044     History of Changes
Other Study ID Numbers: Meropur2009
Study First Received: May 21, 2012
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 21, 2014