Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome
NCT ID: NCT02124291
Last Updated: 2017-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
18 participants
INTERVENTIONAL
2014-06-30
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Assisted Hatching of Cleavage Stage Embryos
NCT00120549
Assisted Hatching in Frozen Blastocysts
NCT03833869
Optimal Timing For Embryo Transfer For Low Responder Patients
NCT01040247
Protocols for Improved in Vitro Fertilization (IVF) Outcomes
NCT00334243
The Effect of Laser Assisted Hatching in Thawing Cycles: a Prospective Randomized Controlled Study
NCT00593775
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No Assisted Hatching
No Assisted Hatching
No interventions assigned to this group
Assisted Hatching
Mechanical Assisted Hatching - artificial rupture of the embryo external glycoprotein layer (Zona Pellucida) before embryo transfer.
Mechanical Assisted Hatching
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mechanical Assisted Hatching
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* cleavage-stage embryo transfer,
* less than seven IVF cycles with fresh embryo transfer,
* high quality embryos.
Exclusion Criteria
* blastocyst embryo transfer
* more or equal to seven IVF cycles with fresh embryo transfer
* low quality embryos
18 Years
42 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shaare Zedek Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Volodarsky-Perel Alexander, MD
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexander Volodarsky-Perel, MD
Role: PRINCIPAL_INVESTIGATOR
Shaare Zedek Medical Center, Jerusalem, Israel.
Avi Tsafrir, MD
Role: STUDY_CHAIR
Shaare Zedek Medical Center, Jerusalem, Israel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VitHatSZMC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.