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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.

This study has been completed.
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart Identifier:
First received: May 21, 2012
Last updated: September 4, 2014
Last verified: September 2014
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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

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

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

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 ]

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 ]

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


Ages Eligible for Study:   35 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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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Please refer to this study by its identifier: NCT01604044

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rosanna Apa, professor, Catholic University of the Sacred Heart Identifier: NCT01604044     History of Changes
Other Study ID Numbers: Meropur2009
Study First Received: May 21, 2012
Last Updated: September 4, 2014

Additional relevant MeSH terms:
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female processed this record on May 25, 2017