Clincosm LogoSign in Get a demo

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

Sponsor
Mount Sinai Hospital, Canada (Other)
Overall Status
Completed
CT.gov ID
NCT02058082
Collaborator
(none)
25
Enrollment
2
Arms
78
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intracytoplasmic sperm injection
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Jun 1, 2005
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Live birth rates [Up to 1 year]

Secondary Outcome Measures

  1. sperm DNA damage [Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure]

  2. oocyte fertilization rates [at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)]

  3. embryo cleavage rate [Day 3 post oocytes retrieval]

  4. blastocyst rate [Day 5 post oocytes retrieval]

  5. pregnancy rate [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 [after a clinical pregnancy has been established, up to 10 months after procedure]

  7. birth defects [1-year following delivery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: Kirk C. Lo, MD, MOUNT SINAI HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kirk Lo, Associate Professor, Division Urology Mount Sinai Hospital, University Toronto, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT02058082
Other Study ID Numbers:
  • Sperm DNA damage study
First Posted:
Feb 7, 2014
Last Update Posted:
Feb 7, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Kirk Lo, Associate Professor, Division Urology Mount Sinai Hospital, University Toronto, Mount Sinai Hospital, Canada
Failure to Conceive Due to Infertility of Male Partner
DNA Damage
Additional relevant MeSH terms:
Infertility
Infertility, Male

Study Results

No Results Posted as of Feb 7, 2014