Clinical trial NCT02124291: Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome
Official title: Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Complications Associated With Artificial Fertilization
Placenta; Implantation
Pregnancy
Keywords: In Vitro Fertilization
Vitrification
Frozen Embryo
Assisted Hatching
Pregnancy Rate
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: delivery rate
timeFrame: 9 months
Secondary outcomes:
measure: implantation rate
timeFrame: 1 month
measure: clinical pregnancy rate
timeFrame: 2 months
Other outcomes:
measure: multifetal pregnancy
timeFrame: 2 months
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel.
name: Alexander Volodarsky-Perel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel
name: Avi Tsafrir, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.