Testosterone Gel in Poor Responders Undergoing IVF

NCT02549690 | Withdrawn

• 1 other identifier: NCKH/CGRH_ 06_2015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Infertility

Keywords

IVF, Testosterone gel, DHEA, poor responder.

Outcome Measures

Primary Outcomes (1)

• Number of oocytes

  Number of oocytes retrieved Number of oocytes retrieved

  30 minutes after oocyte retrieval completed

Secondary Outcomes (1)

• Clinical pregnancy

  7 weeks after embryo transfer

Study Arms (2)

Testosterone gel

ACTIVE COMPARATOR

Testosterone gel 10mg, used transdermally, once a day. Treatment duration: 6-8 weeks

Drug: Testosterone gel

DHEA

ACTIVE COMPARATOR

DHEA 25mg tablet, orally, three times per day. Treatment duration: 6-8 weeks

Drug: DHEA

Interventions

Testosterone gel DRUG

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.

Also known as: Androgel

Testosterone gel

DHEA DRUG

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

Also known as: DHEA tablet

DHEA

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vietnam National University: lead
• Mỹ Đức Hospital: collaborator

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Ward 13. Tan Binh District, 70000, Vietnam

Location

MeSH Terms

Conditions

Infertility

Interventions

Testosterone; Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones

Study Officials

• Linh P Tran, MD

  Research Center for Genetics and Reproductive Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 13, 2015
• First Posted: September 15, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

VN (1)