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 1CompletedNCT01604044

Catholic University of the Sacred Heart579 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

579

Conditions

Female Infertility

Interventions

Meropur 150 a dayDRUG

one subcutaneous injection a day

Gonal-f 150 plus Luveris 150DRUG

one subcutaneous injection a day

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 41 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Policlinico Agostino Gemelli

Rome, Rome, Italy

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

Time frame: 30 days

Data from ClinicalTrials.gov

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