Selection of the Embryo to Transfer by Morphokinetics vs.... | NCT04003337

Studies
Selection of the Embryo to Transfer by Morphokinetics vs. Morphological Evaluation.

NCT04003337

Sponsor

Procreatec

Status

Unknown status

Last Update Posted

May 20, 2020Actual

Enrollment

228Estimated

Phase

Not Applicable

Conditions

Embryo Implantation

Interventions

Morpho-kinetics selection with time-lapse (Embryoscope) evaluation

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

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 26, 2017Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Jun 26, 2019

First Submission Date that Met QC Criteria

Jun 27, 2019

First Posted Date

Jul 1, 2019Actual

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

May 19, 2020

Last Update Posted Date

May 20, 2020Actual

Name	Class
Sociedad Espanola Fertilidad	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Our study intends to demonstrate that the selection of an embryo to transfer it at the sage of blastocyst through morphokinetics (analysis of embryos depending not only in their morphology -that is, the aspect of the embryo-, but also based on times of cell division) during the use of time-lapse (Embryoscope®) may have a better impact in clinical results, as selection is not performed in mere morphological evolution (visual aspect of the embryo) of the embryos.

Detailed Description

In order to obtain this objective, patients participating in the study will be randomly assigned to one of the following groups:

Group A: Patients who will perform an embryo transfer of a blastocyst using morphological criteria to evaluate que quality of the blastocyst (Gardner Classification), that is, based on the aspect or form of the embryo.

Group B: Patients who will perform an embryo transfer of a blastocyst using morphokinetics criteria to evaluate the quality of the blastocyst (Embryoscope®), that is, based not only in the aspect of the embryo but also in cell division times experimented by the embryos.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

228Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GROUP A: Morphological embryo selection	No Intervention	Patients enrolled in group A will receive an embryo transfer according to classical morphological criteria.
GROUP B: Morpho-kinetics embryo selection	Active Comparator	Patients enrolled in group B will receive an embryo transfer according to new morphokinetics criteria.	Other: Morpho-kinetics selection with time-lapse (Embryoscope) evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Morpho-kinetics selection with time-lapse (Embryoscope) evaluation	Other	Embryos in group B will be selected in blastocyst stage according to morpho-kinetics criteria before the embryo transfer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy Rate	Positive pregnancy test	12-14 days after the embryo transfer

Secondary Outcomes

Measure	Description	Time Frame
Clinical Pregnancy Rate	US pregnancy confirmation	12-15 days after the positive blood test for pregnancy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Egg-donation IVF patients
IVF patients if < 38 years
Sperm concentration > 2 million/ml
Frozen eggs for
Single embryo transfer
ICSI fertilization

Exclusion Criteria:

Uterine pathologies that may interfere with implantation
Endometriosis
Frozen eggs
Pre implantation genetic testing of the embryos
Day 3 embryo transfer
Conventional IVF treatments

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ester Padilla	Contact	0034914585804	24	esterpadilla@procreatec.com
Lourdes Lopez	Contact	0034914585804		lopezyanez@procreatec.com

Overall Officials

Name	Affiliation	Role
Lourdes Lopez	Procreatec	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Procreatec	Recruiting	Madrid		28036	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020669	Fetoscopes

Ancestor Terms

ID	Term
D019723	Endoscopes
D019719	Diagnostic Equipment
D004864	Equipment and Supplies
D013523	Surgical Equipment

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

Masking Description

Once patients accept to be enrolled in the study, one of the nurses will allocate the patient to one of study groups. Neither the patient nor the doctor will know the group assigned.

Who Masked

ParticipantCare Provider