NCT03833869

Brief Summary

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

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
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

First Submitted

Initial submission to the registry

February 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

June 11, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

February 6, 2019

Last Update Submit

June 6, 2019

Conditions

ART

Outcome Measures

Primary Outcomes (1)

  • Implantation rate

    Number of gestational sacs demonstrated on ultrasound divided by the number of embryos transferred (expressed as percentage)

    Five to six weeks following embryo transfer

Secondary Outcomes (2)

  • Chemical pregnancy

    Five to six weeks following embryo transfer

  • Early spontaneous abortion

    Up to 15 weeks from embryo transfer

Study Arms (2)

Assisted hatching

EXPERIMENTAL

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

Procedure: Assisted hatching

Control

NO INTERVENTION

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

Interventions

Assisted hatchingPROCEDURE

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

Assisted hatching

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edith Wolfson Medical Center

Holon, Israel

RECRUITING

Study Officials

  • Hadas Ganer Herman, MD

    Edith Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadas Ganer Herman, MD

CONTACT

9720526206696hadassganer@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2019

First Posted

February 7, 2019

Study Start

March 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

June 11, 2019

Record last verified: 2019-02

Locations

IL(1)