Assisted Hatching in Frozen Blastocysts

Not Applicable

• Conditions: ART
• Interventions: Procedure: Assisted hatching

• Registration Number: NCT03833869
• Lead Sponsor: Wolfson Medical Center

Brief Summary

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

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 Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-07
• Study Start: 2019-03-01
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-11
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assisted hatching	Assisted hatching	Five-day frozen embryos will undergo assisted hatching prior to embryo transfer

Primary Outcome Measures

Name	Time	Method
Implantation rate	Five to six weeks following embryo transfer	Number of gestational sacs demonstrated on ultrasound divided by the number of embryos transferred (expressed as percentage)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Edith Wolfson Medical Center; 🇮🇱 H̱olon, Israel