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

February 6, 2014 updated by: Kirk Lo, Mount Sinai Hospital, Canada

Randomized Control Trial on the Use of Testicular Versus Ejaculated Spermatozoa for IVF/ICSI on Pregnancy Outcomes for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ejaculated sperm
Intracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm
Procedure: Intracytoplasmic sperm injection
Active Comparator: testicular extracted sperm
Intracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm
Procedure: Intracytoplasmic sperm injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth rates
Time Frame: Up to 1 year
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sperm DNA damage
Time Frame: Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure
Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure
oocyte fertilization rates
Time Frame: at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)
at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)
embryo cleavage rate
Time Frame: Day 3 post oocytes retrieval
Day 3 post oocytes retrieval
blastocyst rate
Time Frame: Day 5 post oocytes retrieval
Day 5 post oocytes retrieval
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 to 8 week ultrasound
rate of spontaneous abortion
Time Frame: after a clinical pregnancy has been established, up to 10 months after procedure
after a clinical pregnancy has been established, up to 10 months after procedure
birth defects
Time Frame: 1-year following delivery
1-year following delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: Kirk C. Lo, MD, Mount Sinai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

February 6, 2014

First Posted (Estimate)

February 7, 2014

Study Record Updates

Last Update Posted (Estimate)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sperm DNA damage study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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