Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation

September 10, 2018 updated by: Reproductive Medicine Associates of New Jersey
The purpose of this study is to determine if sperm DNA fragmentation is associated with in vitro fertilization (IVF) outcomes when euploid embryos are transferred.

Study Overview

Status

Completed

Conditions

Detailed Description

The purpose of this study is to determine if sperm DNA fragmentation is associated with in vitro fertilization (IVF) outcomes when euploid embryos are transferred. Euploid embryos are those that have a complete set of chromosomes (46, XX or 46, XY). Sperm DNA fragmentation refers to sperm DNA that is damaged or has an altered structure. The sperm chromatin structure assay (SCSA) is a method to evaluate sperm DNA Fragmentation.

Couples will undergo a routine IVF cycle at Reproductive Medicine Associates of New Jersey. Semen specimens collected on the day of ICSI will undergo semen analysis as per routine. An aliquot of semen (0.5- 1mL) will be collected for subsequent evaluation of DNA fragmentation by the Sperm Chromatin Structure Assay (SCSA) testing at SCSA Diagnostics. All embryo biopsies will undergo CCS analysis in the genomics laboratory, Foundation for Assessment and Enhancement of Embryonic Competence.

Study Type

Observational

Enrollment (Actual)

323

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Reproductive Medicine Associates of new Jersey
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Reproductive Medicine Associates of Pennsylvania at LeHigh Valley

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

35 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Couples completing their first IVF/ICSI cycle at Reproductive Medicine Associates of New Jersey utilizing CCS (Comprehensive Chromosome Screening).

Description

Inclusion Criteria:

  • Completing first IVF/ICSI cycle at Reproductive Medicine Associates of New Jersey
  • Couple undergoing CCS (Comprehensive Chromosome Screening)
  • Female age 35-40 years
  • Male will have to refrain from ejaculation no less than 2 days but no greater than 5 days prior semen specimen production on day of oocyte retrieval

Exclusion Criteria:

  • Known genetic abnormality
  • Use of sperm donation or cryopreserved sperm
  • Use of Oocyte donation
  • Use of gestational carrier
  • Use of testicular aspiration or biopsy procedures to obtain sperm
  • Presence of varicosele
  • Presence of hydrosalpinges that communicate with endometrial cavity
  • Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IVF/ICSI Pregnancy Outcomes with euploid blastocyst transfer based on sperm DNA fragmentation
Time Frame: 28 months
rates of fertilization, blastulation, implantation, sustained implantation, delivery and miscarriage
28 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between semen analysis parameters and sperm DNA fragmentation
Time Frame: 28 months
Semen analysis parameters (total motile sperm count, Volume, Concentration, Grade 1-4 )
28 months
Correlation between sperm DNA fragmentation and embryonic aneuploidy
Time Frame: 28 months
28 months

Collaborators and Investigators

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

Sponsor

Reproductive Medicine Associates of New Jersey

Investigators

  • Principal Investigator: Richard T Scott, MD, HCLD, Reproductive Medicine Associates of new Jersey

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

October 1, 2014

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMA-2014-05

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.

Clinical Trials on Male Infertility

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe