Efficacy of Luteinizing Hormone (LH) Activity in Low Responder Patients With Transdermal Testosterone
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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
time frame: within 2 weeks after begining ovarian stimulation
clinical pregnancy rate
time frame: within 5 weeks (plus or minus 1 week) after embryo transfer
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
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
|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.|
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