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 Heart

Status and phase: Completed; Phase 1

Conditions: Female Infertility

Treatments: Drug: Meropur 150 a day; Drug: Gonal-f 150 plus Luveris 150

Study type: Interventional

Funder types: Other

Identifiers

NCT01604044

Meropur2009

Details and patient eligibility

About

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

Enrollment: 579 patients

Sex: Female

Ages: 35 to 41 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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579 participants in 2 patient groups

HP-hMG

Active Comparator group

Treatment:

Drug: Meropur 150 a day

rFSH plus rLH

Active Comparator group

Treatment:

Drug: Gonal-f 150 plus Luveris 150