Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.

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: September 4, 2014
Last verified: September 2014
  Purpose

This study evaluates 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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • ongoing pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • number of cancelled cycles for low or no response, the number of interrupted cycles for high risk of OHSS and multiple pregnancies [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • duration of stimulation, total gonadotropin dose, number of midsize follicles, dominant follicles, E2 levels, endometrial thickness on hCG day, Progesterone levels, endometrial thickness on the midluteal phase. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 579
Study Start Date: May 2012
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:   35 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
  • regular ovulatory menstrual cycles
  • BMI ≤27 kg/m2
  • normal day 3 hormonal pattern
  • bilateral tubal patency

Exclusion Criteria:

  • mono/bilateral tubal occlusion,
  • severe male factor
  • polycystic ovarian syndrome or any systemic disease or endocrine or metabolic abnormalities
  • pelvic inflammatory disease
  • endometriosis
  • sexual organ malformations
  • neoplasms or breast pathology incompatible with gonadotropin stimulation.
  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: September 4, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014