The effect of Testosterone Undecanoate (TU) alone or combined with Depot Medroxyprogesterone Acetate (DMPA) on sperm production of Indonesian fertile me

Completed

• Conditions: Male contraception; Pregnancy and Childbirth; Contraception

• Registration Number: ISRCTN80724703
• Lead Sponsor: DP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Current inclusion criteria as of 24/09/2007:
Male participants:
1. Age 21 to 45 years
2. Good general health
3. Blood parameters (peptide hormones, clinical chemistry, haematology, Prostate Specific Antigen [PSA]) in normal range
4. Semen parameters in normal range:
4.1. Sperm concentration 20 million/mL
4.2. Sperm morphology greater than 30% normal
4.3. Sperm 50% forwardly motile
5. Couples must be in a stable relationship, dissatisfied with their current method of contraception and have no history of infertility

Female partners:
1. Age of consent to 35 years
2. Regular menstrual cycles
3. No history of Pelvic Inflammatory Disease (PID) in last 12 months
4. Not pregnant
5. Willing to have physical exam and to participate in trial

Previous inclusion criteria:
Male participants:
1. Age 21 to 45 years
2. Good general health
3. Blood parameters (peptide hormones, clinical chemistry, haematology) in normal range
4. Semen parameters in normal range:
a. sperm concentration 20 million/mL
b. sperm morphology greater than 30% normal
c. sperm 50% forwardly motile

Female partners:
1. Age of consent to 35
2. Regularly cycling
3. No history of Pelvic Inflammatory Disease (PID) in last 12 months
4. Not pregnant
5. Willing to have physical exam and to participate in trial

Exclusion Criteria

Added 24/09/07:
1. History of active or chronic cardiac, renal, hepatic or prostatic disease or other serious diseases such as diabetes mellitus, hyperlipoproteinemia, etc.
2. Men with active or persistent genitourinary infection
3. Use of medication such as sex steroids or barbiturate
4. Couples in which the wife is breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified