Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome

NCT02124291 | Terminated DMC

• 1 other identifier: VitHatSZMC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications Associated With Artificial Fertilization; Placenta; Implantation; Pregnancy

Keywords

In Vitro Fertilization; Vitrification; Frozen Embryo; Assisted Hatching; Pregnancy Rate

Outcome Measures

Primary Outcomes (1)

• delivery rate

  9 months

Secondary Outcomes (2)

• implantation rate

  1 month

• clinical pregnancy rate

  2 months

Other Outcomes (1)

• multifetal pregnancy

  2 months

Study Arms (2)

No Assisted Hatching

NO INTERVENTION

No Assisted Hatching

Assisted Hatching

ACTIVE COMPARATOR

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

Device: Mechanical Assisted Hatching

Interventions

Mechanical Assisted Hatching DEVICE

The technique of assisted hatching using partial zona pellucida dissection to create an artificial opening of the zona pellucida of early cleaved embryos. While the embryo is stabilized by a holding pipette of micromanipulator, the zona pellucida is pierced with a microneedle that is pushed tangentially through the space between the zona pellucida and blastomeres until it pierces through the zona pellucida again.

Assisted Hatching

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 3235, Israel

Location

Related Publications (9)

• Sagoskin AW, Levy MJ, Tucker MJ, Richter KS, Widra EA. Laser assisted hatching in good prognosis patients undergoing in vitro fertilization-embryo transfer: a randomized controlled trial. Fertil Steril. 2007 Feb;87(2):283-7. doi: 10.1016/j.fertnstert.2006.07.1498. Epub 2006 Nov 13.

  PMID: 17094975 BACKGROUND

• Fang C, Li T, Miao BY, Zhuang GL, Zhou C. Mechanically expanding the zona pellucida of human frozen thawed embryos: a new method of assisted hatching. Fertil Steril. 2010 Sep;94(4):1302-1307. doi: 10.1016/j.fertnstert.2009.08.014. Epub 2009 Sep 26.

  PMID: 19782973 BACKGROUND

• Valojerdi MR, Eftekhari-Yazdi P, Karimian L, Ashtiani SK. Effect of laser zona pellucida opening on clinical outcome of assisted reproduction technology in patients with advanced female age, recurrent implantation failure, or frozen-thawed embryos. Fertil Steril. 2008 Jul;90(1):84-91. doi: 10.1016/j.fertnstert.2007.06.005. Epub 2007 Sep 24.

  PMID: 17889864 BACKGROUND

• Ng EH, Naveed F, Lau EY, Yeung WS, Chan CC, Tang OS, Ho PC. A randomized double-blind controlled study of the efficacy of laser-assisted hatching on implantation and pregnancy rates of frozen-thawed embryo transfer at the cleavage stage. Hum Reprod. 2005 Apr;20(4):979-85. doi: 10.1093/humrep/deh724. Epub 2005 Jan 21.

  PMID: 15665025 BACKGROUND

• Martins WP, Rocha IA, Ferriani RA, Nastri CO. Assisted hatching of human embryos: a systematic review and meta-analysis of randomized controlled trials. Hum Reprod Update. 2011 Jul-Aug;17(4):438-53. doi: 10.1093/humupd/dmr012. Epub 2011 Apr 7.

  PMID: 21474527 BACKGROUND

• Valojerdi MR, Eftekhari-Yazdi P, Karimian L, Hassani F, Movaghar B. Effect of laser zona thinning on vitrified-warmed embryo transfer at the cleavage stage: a prospective, randomized study. Reprod Biomed Online. 2010 Feb;20(2):234-42. doi: 10.1016/j.rbmo.2009.11.002. Epub 2009 Nov 18.

  PMID: 20113961 BACKGROUND

• Carney SK, Das S, Blake D, Farquhar C, Seif MM, Nelson L. Assisted hatching on assisted conception (in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD001894. doi: 10.1002/14651858.CD001894.pub5.

  PMID: 23235584 BACKGROUND

• Gabrielsen A, Agerholm I, Toft B, Hald F, Petersen K, Aagaard J, Feldinger B, Lindenberg S, Fedder J. Assisted hatching improves implantation rates on cryopreserved-thawed embryos. A randomized prospective study. Hum Reprod. 2004 Oct;19(10):2258-62. doi: 10.1093/humrep/deh434. Epub 2004 Aug 19.

  PMID: 15319388 BACKGROUND

• Wan CY, Song C, Diao LH, Li GG, Bao ZJ, Hu XD, Zhang HZ, Zeng Y. Laser-assisted hatching improves clinical outcomes of vitrified-warmed blastocysts developed from low-grade cleavage-stage embryos: a prospective randomized study. Reprod Biomed Online. 2014 May;28(5):582-9. doi: 10.1016/j.rbmo.2014.01.006. Epub 2014 Jan 27.

  PMID: 24631166 BACKGROUND

Study Officials

• Alexander Volodarsky-Perel, MD

  Shaare Zedek Medical Center, Jerusalem, Israel.

  PRINCIPAL INVESTIGATOR

• Avi Tsafrir, MD

  Shaare Zedek Medical Center, Jerusalem, Israel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 28, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

IL (1)