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

Not Applicable

• Conditions: Other Complications Associated With Artificial Fertilization
• Interventions: Drug: Testosterone and FSHr-LHr; Drug: testosterone and FSHr alone

• Registration Number: NCT01291212
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Last Update Submitted: 2011-02-07
• Study First Posted: 2011-02-08
• Last Update Posted: 2011-02-08
• Primary Completion: 2011-06
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

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

Exclusion Criteria

• FSH > 12
• Previous ovarian surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
testosterone and FSHr-LHr	Testosterone and FSHr-LHr	-
Testosterone and FSHr	testosterone and FSHr alone	-

Primary Outcome Measures

Name	Time	Method
ovarian response	within 2 weeks after begining ovarian stimulation	number of oocytes obtained per ovarian stimulation cycle

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rate	within 5 weeks (plus or minus 1 week) after embryo transfer	The number of clinical pregnancies expressed per embryo transfer cycles. Clinical pregnancy: a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Multiple gestational sacs are counted as one clinical pregnancy.
Implantation rate	within 5 weeks (plus/minus 1 week) after embryo transfer	The number of gestational sacs (observed by ultrasound examination) divided by the number of embryos transferred.
Live birth rate	within 9 months (plus/minus 1 month) after embryo transfer	The number of deliveries that resulted in at least one live born baby expressed per 100 embryo transfer cycles.

Trial Locations

Locations (1)

Hospital Clínic; 🇪🇸 Barcelona, Spain