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
|Condition or disease||Intervention/treatment||Phase|
|Other Complications Associated With Artificial Fertilization||Drug: Testosterone and FSHr-LHr Drug: testosterone and FSHr alone||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|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|
|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
- ovarian response [ Time Frame: within 2 weeks after begining ovarian stimulation ]number of oocytes obtained per ovarian stimulation cycle
- 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.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291212
|Barcelona, Spain, 08036|