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

February 7, 2011 updated by: Hospital Clinic of Barcelona

Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 41 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Testosterone and FSHr
Drug: 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
Drug: Testosterone and FSHr-LHr
75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ovarian response
Time Frame: within 2 weeks after begining ovarian stimulation
number of oocytes obtained per ovarian stimulation cycle
within 2 weeks after begining ovarian stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 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.
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
The number of gestational sacs (observed by ultrasound examination) divided by the number of embryos transferred.
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
The number of deliveries that resulted in at least one live born baby expressed per 100 embryo transfer cycles.
within 9 months (plus/minus 1 month) after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 8, 2011

Study Record Updates

Last Update Posted (Estimate)

February 8, 2011

Last Update Submitted That Met QC Criteria

February 7, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIV-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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