Sperm Pathology Samples and Morphokinetics | NCT02155179

Studies
Sperm Pathology Samples and Morphokinetics

NCT02155179

Sponsor

IVI Madrid

Status

Completed

Last Update Posted

Aug 13, 2019Actual

Enrollment

112Actual

Phase

Not provided

Conditions

Cylinical Embryo
Oligospermia

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Jun 2, 2014

First Submission Date that Met QC Criteria

Jun 3, 2014

First Posted Date

Jun 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2019

Last Update Posted Date

Aug 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Good prognosis		Sperm samples >15mill/ml >30% progresive sperms
bad prognosis		Sperm samples <5mill/ml <5% progresive sperms

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Sperms samples of assisted reproduction treatments

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
david agudo, PhD	lab coordinator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IVI MAdrid		Madrid		28023	Spain

Condition Browse Module

MeSH Terms

ID	Term
D009845	Oligospermia

Ancestor Terms

ID	Term
D007248	Infertility, Male
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided