Assisted Hatching in Frozen Blastocysts

ART Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03833869
• Other study ID #: 0020-19-WOMC
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 2020

Study information

• Verified date: February 2019
• Source: Wolfson Medical Center
• Contact: Hadas Ganer Herman, MD
• Phone: 9720526206696
• Email: hadassganer[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• ART

Intervention

Procedure:
• Assisted hatching
Controlled hatching of the zona pellucida in the laboratory prior to embryo transfer

Locations

Country	Name	City	State
Israel	Edith Wolfson Medical Center	H_olon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Early spontaneous abortion	Spontaneous abortion of pregnancy during the first trimester of pregnancy	Up to 15 weeks from embryo transfer