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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014