Clinical trial NCT02549690: Testosterone Gel in Poor Responders Undergoing IVF
Official title: Effectiveness of Testosterone Gel Pretreatment in Poor Responders Undergoing IVF Treatment: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infertility
Keywords: IVF, Testosterone gel, DHEA, poor responder.
Lead sponsor: Vietnam National University
Sponsor class: OTHER
Collaborators: name: Mỹ Đức Hospital
First posted: 2015-09-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Number of oocytes
timeFrame: 30 minutes after oocyte retrieval completed
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: 7 weeks after embryo transfer
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Hospital
state: Ward 13. Tan Binh District
Study officials:
affiliation: Research Center for Genetics and Reproductive Health
name: Linh P Tran, MD
role: STUDY_DIRECTOR
References: