Overview

This trial is active, not recruiting.

Condition other complications associated with artificial fertilization
Treatments testosterone and fshr-lhr, testosterone and fshr alone
Sponsor Hospital Clinic of Barcelona
Start date January 2011
End date June 2011
Trial size 104 participants
Trial identifier NCT01291212, FIV-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
testosterone and fshr alone
FSHr alone used in ovarian stimulation in IVF, when testosterone was used to improve the ovarian response
(Active Comparator)
testosterone and fshr-lhr
75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response

Primary Outcomes

Measure
ovarian response
time frame: within 2 weeks after begining ovarian stimulation

Secondary Outcomes

Measure
clinical pregnancy rate
time frame: within 5 weeks (plus or minus 1 week) after embryo transfer
Implantation rate
time frame: within 5 weeks (plus/minus 1 week) after embryo transfer
Live birth rate
time frame: within 9 months (plus/minus 1 month) after embryo transfer

Eligibility Criteria

Female participants from 18 years up to 41 years old.

Inclusion Criteria: - Low responder patients: patients with previously canceled cycle or recovery of 3 or less oocytes Exclusion Criteria: - FSH > 12 - Previous ovarian surgery

Additional Information

Official title Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by Hospital Clinic of Barcelona.