Complications Associated With Artificial FertilizationVitHatSZMCNCT02124291
Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome
A study testing Mechanical Assisted Hatching in people with Complications Associated With Artificial Fertilization and Placenta; Implantation, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Complications Associated With Artificial Fertilization, Placenta; Implantation, Pregnancy
- What is being tested?
- Mechanical Assisted Hatching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women age 18-42,
- cleavage-stage embryo transfer,
- less than seven IVF cycles with fresh embryo transfer,
- high quality embryos.
Who cannot join
- out of 18-42 y.o.
- blastocyst embryo transfer
- more or equal to seven IVF cycles with fresh embryo transfer
- low quality embryos
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Mechanical Assisted Hatching
- Keywords
- In Vitro Fertilization, Vitrification, Frozen Embryo, Assisted Hatching, Pregnancy Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Assisted HatchingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mechanical Assisted Hatching |
What is being measured
The primary outcome is the main question the study is designed to answer.
delivery rate
Measured: 9 months
Secondary outcomes (2)
implantation rate
Measured: 1 month
clinical pregnancy rate
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionJun 2016
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Complications Associated With Artificial FertilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volodarsky-Perel Alexander, MD, Shaare Zedek Medical Center
- Investigators
- Alexander Volodarsky-Perel, MD, Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel.Avi Tsafrir, MD, Study chair, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124291
- Sponsor's protocol ID
- VitHatSZMC
- Acronym
- VitHatSZMC
- Status last verified
- Apr 2017
- First submitted
- 23 Apr 2014
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17094975Fang 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.
PubMed 19782973Valojerdi 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.
PubMed 17889864Ng 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.
PubMed 15665025Martins 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.
PubMed 21474527Valojerdi 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.
PubMed 20113961Carney 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.
PubMed 23235584Gabrielsen 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.
PubMed 15319388Wan 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.
PubMed 24631166
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome
- ClinicalTrials.gov ID
- NCT02124291
- Acronym / sponsor ID
- VitHatSZMC / VitHatSZMC
- Keywords
- In Vitro Fertilization, Vitrification, Frozen Embryo, Assisted Hatching, Pregnancy Rate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Assisted Hatching | No intervention | –No Assisted Hatching |
| Assisted Hatching | Active comparator | Device: Mechanical Assisted HatchingMechanical Assisted Hatching - artificial rupture of the embryo external glycoprotein layer (Zona Pellucida) before embryo transfer. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women age 18-42,
- cleavage-stage embryo transfer,
- less than seven IVF cycles with fresh embryo transfer,
- high quality embryos.
Key exclusion criteria (4 listed)
- out of 18-42 y.o.
- blastocyst embryo transfer
- more or equal to seven IVF cycles with fresh embryo transfer
- low quality embryos
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Assisted HatchingThe 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. | Device | Assisted Hatching |
Primary outcome
delivery rate
Time frame: 9 months
2 secondary outcomes
implantation rate
Time frame: 1 month
clinical pregnancy rate
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 17094975Sagoskin 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.
- Background: PubMed 19782973Fang 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.
- Background: PubMed 17889864Valojerdi 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.
- Background: PubMed 15665025Ng 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.
- Background: PubMed 21474527Martins 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.
- Background: PubMed 20113961Valojerdi 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.
- Background: PubMed 23235584Carney 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.
- Background: PubMed 15319388Gabrielsen 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.
- Background: PubMed 24631166Wan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Volodarsky-Perel, MD principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel.
Avi Tsafrir, MD study chair
Shaare Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Assisted Hatching in people with Complications Associated With Artificial Fertilization and Placenta; Implantation, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delivery rate (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02124291, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.