NCT02976662

Brief Summary

Investigators aim to investigate the effect of elimination of blastocoelic fluid by creating a large hole in the zona pellucida at the cellular junction of the trophectoderm cells located far away from the inner cell mass with a laser pulse before vitrification.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

November 25, 2016

Last Update Submit

November 28, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Implantation rate

    number of intrauterine gestational sacs over the total number of embryos transferred

    1 month

Study Arms (2)

Artificial shrinkage

EXPERIMENTAL

Elimination of blastocoelic fluid by creating a large hole in the zona pellucida at the cellular junction of the trophectoderm cells located far away from the inner cell mass with a laser pulse before vitrification.

Procedure: Artificial shrinkage

Without Artificial shrinkage

NO INTERVENTION

Vitrify expanded blastocysts.

Interventions

Artificially eliminated blastocoelic fluid before vitrification procedures.

Artificial shrinkage

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI of ≤ 32

You may not qualify if:

  • Non-expanded blastocysts.
  • Women who had uterine pathology or abnormality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasmin Magdi

Banhā, Egypt

RECRUITING

Central Study Contacts

Yasmin Magdi, M.Sc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific IVF lab director

Study Record Dates

First Submitted

November 25, 2016

First Posted

November 29, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations