Assisted Hatching in Frozen Blastocysts

NCT ID: NCT03833869

Last Updated: 2019-06-11

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-03-31

Brief Summary

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The current study aims to assess the effect of assisted hatching on the implantation rate of frozen blastocytes.

Detailed Description

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The Zona Pellucida protects the ovum from the penetration of multiple sperm, and from mechanical and physiological damage until the fertilized ovum reaches the uterus. Subsequently, spontaneous hatching occurs, and enables the embryo to attach to the endometrium. The technique of assisted hatching was originally investigated as a means to improve implantation in cases of zona hardening, and is commonly performed in 3-day embryos. In the current study, the investigators aim to investigate the effect of assisted hatching on 5-day frozen embryos.

Conditions

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ART

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Assisted hatching

Five-day frozen embryos will undergo assisted hatching prior to embryo transfer

Group Type EXPERIMENTAL

Assisted hatching

Intervention Type PROCEDURE

Controlled hatching of the zona pellucida in the laboratory prior to embryo transfer

Control

Five-day frozen embryos will not undergo any additional procedures prior to embryo transfer

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Assisted hatching

Controlled hatching of the zona pellucida in the laboratory prior to embryo transfer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* In-vitro fertilization patients at the investigators' institution, intended to undergo a transfer of a frozen five-day embryo (blastocyte)
* 18 to 39 years old
* First to third treatment cycle
* Patient has previously had a maximum of four embryos transferred.

Exclusion Criteria

* Over 40 years old
* Congenital or acquired uterine malformations
* Hydrosalpinx
* Chronic autoimmune diseases
* Embryo intended to be undergo preimplantation genetic diagnosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hadas Ganer Herman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hadas Ganer Herman, MD

Role: PRINCIPAL_INVESTIGATOR

Edith Wolfson Medical Center

Locations

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Edith Wolfson Medical Center

Holon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Hadas Ganer Herman, MD

Role: CONTACT

9720526206696

Facility Contacts

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Hadas Ganer Herman, MD

Role: primary

Other Identifiers

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0020-19-WOMC

Identifier Type: -

Identifier Source: org_study_id

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