Does DNA Sperm Fragmentation Affects Embryo Morphokinetic? (MACs-ESD)

April 3, 2018 updated by: David Agudo Garcillan, IVI Madrid

Embryo Development Measure Depending on the DNA Sperm Fragmentation

The embryokinetics may be a new prognostic factor for choosing the human embryos with the highest implantation potential. In order to identify the factors that may affect the rate of embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen tension, oocyte quality or type of medication used for ovarian stimulation. However there are no published data with respect to the influence of sperm DNA fragmentation in the embryo kinetic.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Spain
      • Madrid, Spain, 28023
        • IVI Madrid

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

36 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 36 to 38 years
  • Fresh sample semen
  • Minimum 6 oocytes
  • Semen sample with at least 5 million/ml and at least 30% of progressive motile sperm.

Exclusion Criteria:

  • Patients younger than 36 or older than 38 years old
  • Frozen semen sample
  • Less tan 6 oocytes.
  • Semen samples with less than 5 million / ml or less than 30% of motile sperm.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MACS
Patients with MACS Selection
Other: MACS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of pronuclear appearance in hours.
Time Frame: The mean time of appearance of pronuclei is 3.3951 hours in our patients. We are going to evaluate pronuclear appearence time in hours in our study groups

We want to study whether differences exist in the time of appearance of pronuclei in those embryos that derived from semen samples from the two study groups

the minimum value of the difference to be detected; we said that about 3 hours apart.
The mean time of appearance of pronuclei is 3.3951 hours in our patients. We are going to evaluate pronuclear appearence time in hours in our study groups

Collaborators and Investigators

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

Sponsor

IVI Madrid

Investigators

  • Study Director: Manuela Alonso, IVI Madrid
  • Study Director: David Agudo, PhD, IVI Madrid
  • Study Chair: Maria Testillano, IVI Madrid
  • Study Director: Alberto Pacheco, PhD, IVI Madrid

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

February 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

July 25, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MADDA12201301

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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