Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome

Not Applicable

Terminated

• Conditions: Placenta; Implantation; Pregnancy; Complications Associated With Artificial Fertilization
• Interventions: Device: Mechanical Assisted Hatching

• Registration Number: NCT02124291
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

The objective of study is to assess the possible impact of assisted hatching on the implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human embryos.

Detailed Description

The embryo implantation rate in assisted reproduction procedures is 20%, which leads to a low clinical pregnancy rate (35%), and even lower live birth rate (25%), per cycle started. Low embryo quality, poor endometrial receptivity, difficulties during the blastocyst hatching process are frequently denoted as the main reasons for the low implantation rate in humans.

The artificial rupture or thinning of the zona pellucida before embryo transfer-assisted hatching (AH)-has been proposed to foster spontaneous hatching and improve embryo implantation rates. Despite great effort, the clinical relevance of AH remains controversial and elusive.

There is a great importance of AH during frozen embryo cycles. Due to previous studies there is no precise answer about the value of AH performed on cryopreserved-thawed embryos. As far as is known, there is no clinical data to indicate the effects of AH on vitrified-warmed embryo transfer.

The objective of this prospective study is to assess the possible impact of assisted hatching on the implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human embryos.

Eligibility criteria: women age 18-42, cleavage-stage embryo transfer, less than seven IVF cycles with fresh embryo transfer, high quality embryos.

Procedure: mechanical Assisted Hatching

Primary Outcome: delivery rate Secondary Outcome: implantation rate, pregnancy rate and delivery rate.

Study Timeline

• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-28
• Study Start: 2014-06
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• women age 18-42,
• cleavage-stage embryo transfer,
• less than seven IVF cycles with fresh embryo transfer,
• high quality embryos.

Exclusion Criteria

• out of 18-42 y.o.
• blastocyst embryo transfer
• more or equal to seven IVF cycles with fresh embryo transfer
• low quality embryos

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assisted Hatching	Mechanical Assisted Hatching	Mechanical Assisted Hatching - artificial rupture of the embryo external glycoprotein layer (Zona Pellucida) before embryo transfer.

Primary Outcome Measures

Name	Time	Method
delivery rate	9 months

Secondary Outcome Measures

Name	Time	Method
implantation rate	1 month
clinical pregnancy rate	2 months

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel