Testosterone Gel in Poor Responders Undergoing IVF

Study Overview
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Brief Summary
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The main purpose of this study is to compare the number of oocytes retrieved after using transdermal testosterone gel 10 mg per day or Dehydroepiandrosterone (DHEA) 75mg per day for 6-8 weeks as pre-treatment for poor ovarian responders undergoing in-vitro fertilization (IVF).

Detailed Description
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A randomized controlled multiple centers study. The study is designed as a superiority trial. The sample size for this trial of 120 subjects in both groups, based upon the primary endpoint of the number of oocytes retrieved. IVF patients who have failed to conceive and had poor ovarian response (oocytes retrieved ≤ 3) in the last stimulated cycle though using the maximal dose, which is ≥ 300 IU Follicle-stimulating hormone (FSH) or human menopausal gonadotropin (hMG). Patients will be randomized to use DHEA or testosterone gel as pretreatment. Randomization will be performed using sealed envelopes developed via a computer generated list with blocks of four. Doctors will be blinded to the randomization, but not patients and nurses. Study group 1 use 10 mg transdermal testosterone gel per day. Study group 2 use 75mg DHEA per day. Serum testosterone are measured before treatment. Duration of androgen supplement is 6-8 weeks. After completing the pretreatment, patients are asked to come back when they have menses to begin IVF treatment. Serum testosterone is measured again after the pretreatment in both groups. Patients will be interviewed for side effects and compliance of treatment. After treatment, patients in both group undergo IVF treatment. IVF treatment will then be performed for all patients, according to the current hospital treatment protocols. Patients will be followed up until 7th week of gestation, if they have positive pregnancy test after embryo transfer. Data Analysis and Statistics: The investigators use Statistical Package for the Social Sciences (SPSS) software 20th version to analyze data. The primary end-point mean of number of retrieved oocytes will be compared between two groups using the Student's t test. The secondary end-points will also be compared between the 2 groups using either the Student's t test or chi-square test.

Official Title
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Effectiveness of Testosterone Gel Pretreatment in Poor Responders Undergoing IVF Treatment: a Randomized Controlled Trial

Conditions
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Infertility

Intervention / Treatment
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* Drug: Testosterone gel
* Drug: DHEA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for enrolment into this trial, each female subject must fulfill all of the following criteria at the start of enrolment, unless specified otherwise: Had one or two previous failure IVF cycle, using GnRH antagonist protocol (≥ 300 IU FSH/hMG per day) and the number of retrieved oocytes are ≤ 3; Antral follicle counts (AFC) < 6 or Anti-Mullerian Hormone (AMH) < 1.26 ng/ml Exclusion Criteria: To be eligible for enrolment in this study each subject must not meet any of the following criteria: Oocyte donation cycle Patients have thyroid disease Patients have liver or kidney dysfunction Patients have abnormal puberty or genital development. Patients have previous surgery on ovaries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testosterone gel<br>Testosterone gel 10mg, used transdermally, once a day. Treatment duration: 6-8 weeks | Drug: Testosterone gel<br>* Apply 10mg testosterone gel to the abdomen and rub on with one finger, once a day, in the morning, then allow sites to dry and cover with clothing. Continue the treatment for 6-8 weeks until next IVF treatment.<br>* Other names: Androgel;|
| Active Comparator: DHEA<br>DHEA 25mg tablet, orally, three times per day. Treatment duration: 6-8 weeks | Drug: DHEA<br>* Take DHEA 25mg tablet orally, three times per day. Continue the treatment for 6-8 weeks, until next IVF treatment.<br>* Other names: DHEA tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes | Number of oocytes retrieved Number of oocytes retrieved | 30 minutes after oocyte retrieval completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | Clinical pregnancy is defined by the image gestational sac under ultrasonography | 7 weeks after embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Testosterone gel, DHEA, poor responder.