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.

Phase 1

Completed

• Conditions: Female Infertility
• Interventions: Drug: Meropur 150 a day; Drug: Gonal-f 150 plus Luveris 150

• Registration Number: NCT01604044
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

This study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 579

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HP-hMG	Meropur 150 a day	-
rFSH plus rLH	Gonal-f 150 plus Luveris 150	-

Primary Outcome Measures

Name	Time	Method
ongoing pregnancy rate	12 weeks

Secondary Outcome Measures

Name	Time	Method
number of cancelled cycles for low or no response, the number of interrupted cycles for high risk of OHSS and multiple pregnancies	30 days

Trial Locations

Locations (1)

Policlinico Agostino Gemelli; 🇮🇹 Rome, Italy