Efficacy of Luteinizing Hormone (LH) Activity in Low Responder Patients With Transdermal Testosterone

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Other Complications Associated With Artificial Fertilization

Treatments: Drug: testosterone and FSHr alone; Drug: Testosterone and FSHr-LHr

Study type: Interventional

Funder types: Other

Identifiers

NCT01291212

FIV-01

Details and patient eligibility

About

The investigators have previously demonstrated the utility of transdermal testosterone in in vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating hormone (FSHr) during ovarian stimulation in these patients.

Full description

Studies in macaques have indicated that androgens have some synergistic effects with follicular stimulating hormone (FSH) on folliculogenesis. Our previous clinical studies demonstrated the usefulness of pretreatment with transdermal testosterone in low-responder IVF patients.

There is controversy on the usefulness of recombinant luteinizing hormone (LHr) added to FSHr in ovarian stimulation of low responder patients. Thus, our present study has been designed to compare ovarian stimulation with FSHr alone versus LHr added to FSHr when transdermal testosterone pretreatment is used.

Enrollment: 104 patients

Sex: Female

Ages: 18 to 41 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Low responder patients: patients with previously canceled cycle or recovery of 3 or less oocytes

Exclusion criteria

• FSH > 12
• Previous ovarian surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Testosterone and FSHr

Active Comparator group

Treatment:

Drug: testosterone and FSHr alone

testosterone and FSHr-LHr

Active Comparator group

Treatment:

Drug: Testosterone and FSHr-LHr