Testosterone Gel in Poor Responders Undergoing IVF

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02549690
• Other study ID #: NCKH/CGRH_ 06_2015
• Status: Withdrawn
• Phase: N/A
• First received: September 13, 2015
• Last updated: April 17, 2017
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: April 2017
• Source: Vietnam National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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.
• DHEA
Take DHEA 25mg tablet orally, three times per day. Continue the treatment for 6-8 weeks, until next IVF treatment.

Locations

Country	Name	City	State
Vietnam	My Duc Hospital	Ho Chi Minh City	Ward 13. Tan Binh District

Sponsors (2)

Lead Sponsor	Collaborator
Vietnam National University	M? Ð?c Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes	Number of oocytes retrieved Number of oocytes retrieved	30 minutes after oocyte retrieval completed
Secondary	Clinical pregnancy	Clinical pregnancy is defined by the image gestational sac under ultrasonography	7 weeks after embryo transfer