Skip to main content
OpenTrials
Completed

NCT Number: NCT02058082

Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage

The purpose of this study is to determine whether couples undergoing IVF/ICSI with male factor infertility, specifically with elevated sperm DNA damage, should testicular sperm extraction be utilized to improve their reproductive outcomes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility, Male DNA Damage Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age
  • be considered infertile (>1 year of unsuccessful attempts of conception
  • Any race
  • Male partner with persistent sperm DNA damage, DFI>=30%
  • candidates for intracytoplasmic sperm injection (ICSI)

Exclusion criteria

  • significant female factor infertility contributing to the couple's infertility
  • female partner older than 38 years
  • male or female patients with genetic abnormalities
  • patients unable or unwilling to give consent after properly informed
  • couples unsuitable for IVF/ICSI
  • male patients in whom testicular procedures were contraindicated

Treatment and study plan

Intracytoplasmic sperm injection

Procedure

Primary outcomes

  1. Live birth rates

    Time frame: Up to 1 year

Secondary outcomes

  1. sperm DNA damage

    Time frame: Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure

  2. oocyte fertilization rates

    Time frame: at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)

  3. embryo cleavage rate

    Time frame: Day 3 post oocytes retrieval

  4. blastocyst rate

    Time frame: Day 5 post oocytes retrieval

  5. pregnancy rate

    Time frame: 6 to 8 week ultrasound

    Clinical pregnancy was defined as the ultrasonographic visualization of one or more gestational sacs and fetal heart at the 6 to 8 week ultrasound

  6. rate of spontaneous abortion

    Time frame: after a clinical pregnancy has been established, up to 10 months after procedure

  7. birth defects

    Time frame: 1-year following delivery

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Official study title

Randomized Control Trial on the Use of Testicular Versus Ejaculated Spermatozoa for IVF/ICSI on Pregnancy Outcomes for Men With High Sperm DNA Damage

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Feb 7, 2014
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.