Testosterone Gel in Poor Responders Undergoing IVF

• ClinicalTrials.gov Identifier: NCT02549690
• Recruitment Status: Withdrawn
• First Posted: September 15, 2015
• Last Update Posted: April 18, 2017
• Sponsor: Vietnam National University
• Collaborator: Mỹ Đức Hospital
• Information provided by (Responsible Party): Manh Tuong Ho, Vietnam National University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: Linh P Tran, MD; Research Center for Genetics and Reproductive Health

More Information

• Responsible Party: Manh Tuong Ho, Doctor, Vietnam National University
• ClinicalTrials.gov Identifier: NCT02549690
• Other Study ID Numbers: NCKH/CGRH_ 06_2015
• First Posted: September 15, 2015
• 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:

Infertility; Testosterone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs