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Artificial Shrinkage for Human Blastocyst Prior Vitrification

NCT ID: NCT02976662

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Human blastocyst formation begins about 5 days after injecting a single sperm into an oocyte in ICSI cycle or incubation of them in IVF cycle. Human blastocyst consists of cells forming an outer layer called trophotoderm that will form the placenta in case of successful implantation, an inner cell mass which become the fetus, a fluid-filled blastocoel cavity in the center, and a surrounding zone pellucida from which the embryo hatches to implant in the uterus. Human blastocyst contains a large amount of liquid in the blastocoel, which alters the infiltration of vitrification solution during the vitrification procedures leading to ice crystal formation. Therefore, investigators need to compare blastocyst survival, clinical pregnancy and implantation rates between vitrified untreated expanded blastocysts and vitrified blastocysts with artificially eliminated blastocoels by a laser pulse prior to vitrification

Conditions

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Vitrification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Artificial shrinkage

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.

Group Type EXPERIMENTAL

Artificial shrinkage

Intervention Type PROCEDURE

Artificially eliminated blastocoelic fluid before vitrification procedures.

Without Artificial shrinkage

Vitrify expanded blastocysts.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Artificial shrinkage

Artificially eliminated blastocoelic fluid before vitrification procedures.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI of ≤ 32

Exclusion Criteria

* Non-expanded blastocysts.
* Women who had uterine pathology or abnormality.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role collaborator

Dar AlMaraa Center

OTHER

Sponsor Role lead

Responsible Party

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Yasmin

Scientific IVF lab director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yasmin Magdi

Banhā, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yasmin Magdi, M.Sc

Role: CONTACT

Phone: +201282313979

Email: [email protected]

Facility Contacts

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Yasmin Magdi, M.Sc

Role: primary

Other Identifiers

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006735

Identifier Type: -

Identifier Source: org_study_id