NCT02214537

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 4, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

July 25, 2014

Last Update Submit

April 3, 2018

Conditions

Blastocyst TimePronuclear AppearancePronuclear FadingEmbryo CompactionCleavage Times

Outcome Measures

Primary Outcomes (1)

  • Time of pronuclear appearance in hours.

    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

Study Arms (1)

MACS

EXPERIMENTAL

Patients with MACS Selection

Other: MACS

Interventions

MACSOTHER
MACS

Eligibility Criteria

Age36 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Madrid

Madrid, 28023, Spain

Location

Study Officials

  • Manuela Alonso

    IVI Madrid

    STUDY DIRECTOR

  • David Agudo, PhD

    IVI Madrid

    STUDY DIRECTOR

  • Maria Testillano

    IVI Madrid

    STUDY CHAIR

  • Alberto Pacheco, PhD

    IVI Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

July 25, 2014

First Posted

August 12, 2014

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

April 4, 2018

Record last verified: 2018-04

Locations

ES(1)