Assisted Hatching in Frozen Blastocysts

• Sponsor: Wolfson Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03833869
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
ART	Procedure: Assisted hatching	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Assisted Hatching on Implantation Rate in Frozen Blastocyst Transfer - a Prospective Randomized Controlled Study
• Actual Study Start Date: Mar 1, 2019
• Anticipated Primary Completion Date: Mar 1, 2020
• Anticipated Study Completion Date: Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Early spontaneous abortion [Up to 15 weeks from embryo transfer]

   Spontaneous abortion of pregnancy during the first trimester of pregnancy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edith Wolfson Medical Center	H̱olon		Israel

Sponsors and Collaborators

• Wolfson Medical Center

Investigators

• Principal Investigator: Hadas Ganer Herman, MD, Edith Wolfson Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hadas Ganer Herman, Principal Investigator, Wolfson Medical Center
• ClinicalTrials.gov Identifier: NCT03833869
• Other Study ID Numbers: 0020-19-WOMC
• First Posted: Feb 7, 2019
• Last Update Posted: Jun 11, 2019
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 11, 2019