Testosterone Gel in Poor Responders Undergoing IVF
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|ClinicalTrials.gov Identifier: NCT02549690|
Recruitment Status : Withdrawn
First Posted : September 15, 2015
Last Update Posted : April 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Testosterone gel Drug: DHEA||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Testosterone Gel Pretreatment in Poor Responders Undergoing IVF Treatment: a Randomized Controlled Trial|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||August 2016|
Active Comparator: Testosterone gel
Testosterone gel 10mg, used transdermally, once a day. Treatment duration: 6-8 weeks
Drug: Testosterone gel
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.
Other Name: Androgel
Active Comparator: DHEA
DHEA 25mg tablet, orally, three times per day. Treatment duration: 6-8 weeks
Take DHEA 25mg tablet orally, three times per day. Continue the treatment for 6-8 weeks, until next IVF treatment.
Other Name: DHEA tablet
- Number of oocytes [ Time Frame: 30 minutes after oocyte retrieval completed ]Number of oocytes retrieved Number of oocytes retrieved
- Clinical pregnancy [ Time Frame: 7 weeks after embryo transfer ]Clinical pregnancy is defined by the image gestational sac under ultrasonography
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): NCT02549690
|My Duc Hospital|
|Ho Chi Minh City, Ward 13. Tan Binh District, Vietnam, 70000|
|Study Director:||Linh P Tran, MD||Research Center for Genetics and Reproductive Health|