Assisted Hatching in Frozen Blastocysts

The Effect of Assisted Hatching on Implantation Rate in Frozen Blastocyst Transfer - a Prospective Randomized Controlled Study

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

Study Overview

• Status: Unknown
• Conditions: ART
• Intervention / Treatment: Procedure: Assisted hatching

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • H̱olon, Israel
    • Recruiting
    • Edith Wolfson Medical Center
    • Contact: Hadas Ganer Herman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Assisted hatching; Five-day frozen embryos will undergo assisted hatching prior to embryo transfer	Procedure: Assisted hatching; Controlled hatching of the zona pellucida in the laboratory prior to embryo transfer
NO_INTERVENTION: Control; Five-day frozen embryos will not undergo any additional procedures prior to embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemical pregnancy	Increase and subsequent decrease in beta HCG levels with no evidence of gestational sac on ultrasound	Five to six weeks following embryo transfer
Early spontaneous abortion	Spontaneous abortion of pregnancy during the first trimester of pregnancy	Up to 15 weeks from embryo transfer

Collaborators and Investigators

• Sponsor: Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (ACTUAL): February 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 0020-19-WOMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No