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

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ClinicalTrials.gov Identifier: NCT01291212
Recruitment Status : Unknown
Verified January 2011 by Hospital Clinic of Barcelona.
Recruitment status was:  Active, not recruiting
First Posted : February 8, 2011
Last Update Posted : February 8, 2011
Sponsor:
Information provided by:
Hospital Clinic of Barcelona

Study Description
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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.

Condition or disease Intervention/treatment Phase
Other Complications Associated With Artificial Fertilization Drug: Testosterone and FSHr-LHr Drug: testosterone and FSHr alone Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study.
Study Start Date : January 2011
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. ovarian response [ Time Frame: within 2 weeks after begining ovarian stimulation ]
    number of oocytes obtained per ovarian stimulation cycle


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • FSH > 12
  • Previous ovarian surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291212


Locations
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Spain
Hospital Clínic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Francisco Fábregues, Hospital Clínic
ClinicalTrials.gov Identifier: NCT01291212    
Other Study ID Numbers: FIV-01
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: February 8, 2011
Last Verified: January 2011
Keywords provided by Hospital Clinic of Barcelona:
In Vitro Fertilization
Testosterone
Ovarian Stimulation
Luteinizing Hormone
Additional relevant MeSH terms:
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Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents