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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02214537
Recruitment Status : Terminated (Because we don´t have the necessary technology anymore)
First Posted : August 12, 2014
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
David Agudo Garcillan, IVI Madrid

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blastocyst Time Pronuclear Appearance Pronuclear Fading Embryo Compaction Cleavage Times Other: MACS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Embryo Development Measure Depending on the DNA Sperm Fragmentation
Study Start Date : February 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: MACS
Patients with MACS Selection
Other: MACS

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02214537

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IVI Madrid
Madrid, Spain, 28023
Sponsors and Collaborators
IVI Madrid
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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

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Responsible Party: David Agudo Garcillan, PHD, IVI Madrid Identifier: NCT02214537    
Other Study ID Numbers: MADDA12201301
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018