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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Recruitment Status : Withdrawn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
Sponsor:
Collaborator:
Mỹ Đức Hospital
Information provided by (Responsible Party):
Manh Tuong Ho, Vietnam National University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Infertility Drug: Testosterone gel Drug: DHEA Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: DHEA
Take DHEA 25mg tablet orally, three times per day. Continue the treatment for 6-8 weeks, until next IVF treatment.
Other Name: DHEA tablet




Primary Outcome Measures :
  1. Number of oocytes [ Time Frame: 30 minutes after oocyte retrieval completed ]
    Number of oocytes retrieved Number of oocytes retrieved


Secondary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 7 weeks after embryo transfer ]
    Clinical pregnancy is defined by the image gestational sac under ultrasonography



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Vietnam
My Duc Hospital
Ho Chi Minh City, Ward 13. Tan Binh District, Vietnam, 70000
Sponsors and Collaborators
Vietnam National University
Mỹ Đức Hospital
Investigators
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Study Director: Linh P Tran, MD Research Center for Genetics and Reproductive Health

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Responsible Party: Manh Tuong Ho, Doctor, Vietnam National University
ClinicalTrials.gov Identifier: NCT02549690     History of Changes
Other Study ID Numbers: NCKH/CGRH_ 06_2015
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Keywords provided by Manh Tuong Ho, Vietnam National University:
IVF, Testosterone gel, DHEA, poor responder.
Additional relevant MeSH terms:
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Dehydroepiandrosterone
Infertility
Genital Diseases, Male
Genital Diseases, Female
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Adjuvants, Immunologic
Immunologic Factors