NCT02155179

Brief Summary

The embryo kinetics may be a new prognostic factor for choosing the 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 semen quality in the embryo kinetic. In this study The investigators propose that the sperm quality may has influence in the embryo division.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

June 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

4.3 years

First QC Date

June 2, 2014

Last Update Submit

August 12, 2019

Conditions

Cylinical EmbryoOligospermia

Outcome Measures

Primary Outcomes (1)

  • embryo division in 2, 3, 4, 5, 6, 7, 8, cells and blastocyst formation

    Exact time of cell cleavages

    between day 0 and day 5 of development

Study Arms (2)

Good prognosis

Sperm samples \>15mill/ml \>30% progresive sperms

bad prognosis

Sperm samples \<5mill/ml \<5% progresive sperms

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sperms samples of assisted reproduction treatments

You may qualify if:

  • Sperm samples with more than 15 mill/ml of sperms, more than 40% of mobile sperms
  • Sperm samples with less than 5 mill/ml of sperms, less than 10% of mobile sperms

You may not qualify if:

  • sperm samples between 5 to 15 mil/ml of sperms and between 10% to 40% of mobile sperms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IVI MAdrid

Madrid, 28023, Spain

Location

Unknown Facility

Madrid, Spain

Location

MeSH Terms

Conditions

Oligospermia

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • david agudo, PhD

    lab coordinator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 4, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations

ES(2)