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

NCT ID: NCT01291212

Last Updated: 2011-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Other Complications Associated With Artificial Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Testosterone and FSHr

Group Type ACTIVE_COMPARATOR

testosterone and FSHr alone

Intervention Type DRUG

FSHr alone used in ovarian stimulation in IVF, when testosterone was used to improve the ovarian response

testosterone and FSHr-LHr

Group Type ACTIVE_COMPARATOR

Testosterone and FSHr-LHr

Intervention Type DRUG

75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response

Interventions

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Testosterone and FSHr-LHr

75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response

Intervention Type DRUG

testosterone and FSHr alone

FSHr alone used in ovarian stimulation in IVF, when testosterone was used to improve the ovarian response

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* FSH \> 12
* Previous ovarian surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Hospital Clínic

Locations

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Hospital Clínic

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.

Reference Type BACKGROUND
PMID: 16517559 (View on PubMed)

Fabregues F, Penarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.1093/humrep/den428. Epub 2008 Dec 3.

Reference Type RESULT
PMID: 19054777 (View on PubMed)

Other Identifiers

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FIV-01

Identifier Type: -

Identifier Source: org_study_id

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