NCT01604044CompletedPhase 1
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.
Catholic University of the Sacred Heart1 site in 1 country579 target enrollmentStarted: May 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 579
- Locations
- 1
- Primary Endpoint
- ongoing pregnancy rate
Study Overview
Brief Summary
This study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 41 Years (Adult)
- Sex
- 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.
Arms & Interventions
HP-hMG
Active Comparator
Intervention: Meropur 150 a day (Drug)
rFSH plus rLH
Active Comparator
Intervention: Gonal-f 150 plus Luveris 150 (Drug)
Outcomes
Primary Outcomes
ongoing pregnancy rate
Time Frame: 12 weeks
Secondary Outcomes
- number of cancelled cycles for low or no response, the number of interrupted cycles for high risk of OHSS and multiple pregnancies(30 days)
Investigators
Rosanna Apa
professor
Catholic University of the Sacred Heart
Study Sites (1)
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