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

Study Overview
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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.

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

Conditions
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Other Complications Associated With Artificial Fertilization

Intervention / Treatment
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* Drug: Testosterone and FSHr-LHr
* Drug: testosterone and FSHr alone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovarian response | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In Vitro Fertilization, Testosterone, Ovarian Stimulation, Luteinizing Hormone