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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.

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ClinicalTrials.gov Identifier: NCT01604044
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 579 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. ongoing pregnancy rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. 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 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   35 Years to 41 Years   (Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01604044


Locations
Italy
Policlinico Agostino Gemelli
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rosanna Apa, professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01604044     History of Changes
Other Study ID Numbers: Meropur2009
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014

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