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Assisted Hatching in Frozen Blastocysts

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03833869
Enrollment
84
Registered
2019-02-07
Start date
2019-03-01
Completion date
2020-03-31
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ART

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.

Interventions

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

Sponsors

Wolfson Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 39 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Implantation rateFive to six weeks following embryo transferNumber of gestational sacs demonstrated on ultrasound divided by the number of embryos transferred (expressed as percentage)

Secondary

MeasureTime frameDescription
Chemical pregnancyFive to six weeks following embryo transferIncrease and subsequent decrease in beta HCG levels with no evidence of gestational sac on ultrasound
Early spontaneous abortionUp to 15 weeks from embryo transferSpontaneous abortion of pregnancy during the first trimester of pregnancy

Countries

Israel

Contacts

Primary ContactHadas Ganer Herman, MD
hadassganer@yahoo.com9720526206696

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026