Artificial Shrinkage of Fresh Blastocysts

NCT02988544 | Completed

• 1 other identifier: RECHMPL16_0267
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine if collapsing an embryo (or making it fold compactly by taking away its fluid) before the transfer in the uterine cavity improves pregnancy rates in assisted reproductive technology (ART). Women coming to our ART center will be randomized in two groups : the collapsing group and a control group. Pregnancy rates will be compared in the two groups. A biomarker (cell free DNA) will also be determined in each group and correlated to pregnancy occurrence.

Conditions

Infertility Assisted Reproductive Technology

Keywords

Single blastocyst embryo transfer; Artificial Shrinkage; Clinical pregnancy rate; Cell free

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate embryo transfer

  Clinical pregnancy rate by transfer evaluate by the visualization of at least one gestational sac with fetal heart activity during pelvic ultrasound confirmed by a positive result of the quantitative βHCG blood test.

  5 weeks

Secondary Outcomes (2)

• Twin pregnancy rate by transfer

  5 weeks

• Free DNA level

  Baseline

Study Arms (2)

Artificial shrinkage (AS) group

EXPERIMENTAL

The Artificial shrinkage group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer

Procedure: Artificial shrinkage

Control group

NO INTERVENTION

No intervention on blastocoelic

Interventions

Artificial shrinkage PROCEDURE

Artificial shrinkage of blastocyst

Artificial shrinkage (AS) group

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Couple eligible for a transfer of a single embryo at the blastocyst stage
• Available couple for a follow up of 12 months

You may not qualify if:

• Attempt with frozen embryo or frozen oocyte
• Attempt with a pre-implantation diagnosis
• Patient has not signed informed consent
• Couple under legal protection, guardianship or guardianship

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

Related Publications (27)

• Czamanski-Cohen J, Sarid O, Cwikel J, Lunenfeld E, Douvdevani A, Levitas E, Har-Vardi I. Increased plasma cell-free DNA is associated with low pregnancy rates among women undergoing IVF-embryo transfer. Reprod Biomed Online. 2013 Jan;26(1):36-41. doi: 10.1016/j.rbmo.2012.09.018. Epub 2012 Oct 4.

  PMID: 23182744 BACKGROUND

• D'Alessandro A, Federica G, Palini S, Bulletti C, Zolla L. A mass spectrometry-based targeted metabolomics strategy of human blastocoele fluid: a promising tool in fertility research. Mol Biosyst. 2012 Apr;8(4):953-8. doi: 10.1039/c1mb05358b. Epub 2011 Oct 21.

  PMID: 22020776 BACKGROUND

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• Gala A, Ferrieres A, Assou S, Monforte M, Bringer-Deutsch S, Vintejoux E, Vincens C, Brunet C, Hamamah S. [Effects of artificial shrinkage prior to vitrification in a closed system: a randomized controlled trial]. Gynecol Obstet Fertil. 2014 Nov;42(11):772-8. doi: 10.1016/j.gyobfe.2014.09.006. Epub 2014 Oct 16. French.

  PMID: 25442824 BACKGROUND

• Gianaroli L, Magli MC, Pomante A, Crivello AM, Cafueri G, Valerio M, Ferraretti AP. Blastocentesis: a source of DNA for preimplantation genetic testing. Results from a pilot study. Fertil Steril. 2014 Dec;102(6):1692-9.e6. doi: 10.1016/j.fertnstert.2014.08.021. Epub 2014 Sep 23.

  PMID: 25256935 BACKGROUND

• Hammadeh ME, Fischer-Hammadeh C, Ali KR. Assisted hatching in assisted reproduction: a state of the art. J Assist Reprod Genet. 2011 Feb;28(2):119-28. doi: 10.1007/s10815-010-9495-3. Epub 2010 Nov 2.

  PMID: 21042844 BACKGROUND

• Hur YS, Park JH, Ryu EK, Yoon HJ, Yoon SH, Hur CY, Lee WD, Lim JH. Effect of artificial shrinkage on clinical outcome in fresh blastocyst transfer cycles. Clin Exp Reprod Med. 2011 Jun;38(2):87-92. doi: 10.5653/cerm.2011.38.2.87. Epub 2011 Jun 30.

  PMID: 22384424 BACKGROUND

• Iwayama H, Hochi S, Yamashita M. In vitro and in vivo viability of human blastocysts collapsed by laser pulse or osmotic shock prior to vitrification. J Assist Reprod Genet. 2011 Apr;28(4):355-61. doi: 10.1007/s10815-010-9522-4. Epub 2010 Dec 9.

  PMID: 21152966 BACKGROUND

• Kato S, Janku F. Cell-free DNA as a novel marker in cancer therapy. Biomark Med. 2015;9(7):703-12. doi: 10.2217/bmm.15.38.

  PMID: 26174844 BACKGROUND

• Kawachiya S, Bodri D, Shimada N, Kato K, Takehara Y, Kato O. Blastocyst culture is associated with an elevated incidence of monozygotic twinning after single embryo transfer. Fertil Steril. 2011 May;95(6):2140-2. doi: 10.1016/j.fertnstert.2010.12.018. Epub 2011 Jan 7.

  PMID: 21215395 BACKGROUND

• Khalaf Y, El-Toukhy T, Coomarasamy A, Kamal A, Bolton V, Braude P. Selective single blastocyst transfer reduces the multiple pregnancy rate and increases pregnancy rates: a pre- and postintervention study. BJOG. 2008 Feb;115(3):385-90. doi: 10.1111/j.1471-0528.2007.01584.x.

  PMID: 18190376 BACKGROUND

• Magli MC, Gianaroli L, Ferraretti AP. Chromosomal abnormalities in embryos. Mol Cell Endocrinol. 2001 Oct 22;183 Suppl 1:S29-34. doi: 10.1016/s0303-7207(01)00574-3.

  PMID: 11576729 BACKGROUND

• MANDEL P, METAIS P. [Nuclear Acids In Human Blood Plasma]. C R Seances Soc Biol Fil. 1948 Feb;142(3-4):241-3. No abstract available. French.

  PMID: 18875018 BACKGROUND

• Palini S, Galluzzi L, De Stefani S, Bianchi M, Wells D, Magnani M, Bulletti C. Genomic DNA in human blastocoele fluid. Reprod Biomed Online. 2013 Jun;26(6):603-10. doi: 10.1016/j.rbmo.2013.02.012. Epub 2013 Mar 13.

  PMID: 23557766 BACKGROUND

• Scalici E, Traver S, Molinari N, Mullet T, Monforte M, Vintejoux E, Hamamah S. Cell-free DNA in human follicular fluid as a biomarker of embryo quality. Hum Reprod. 2014 Dec;29(12):2661-9. doi: 10.1093/humrep/deu238. Epub 2014 Sep 29.

  PMID: 25267787 BACKGROUND

• Schieve LA, Meikle SF, Peterson HB, Jeng G, Burnett NM, Wilcox LS. Does assisted hatching pose a risk for monozygotic twinning in pregnancies conceived through in vitro fertilization? Fertil Steril. 2000 Aug;74(2):288-94. doi: 10.1016/s0015-0282(00)00602-6.

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• Schwarzenbach H, Hoon DS, Pantel K. Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer. 2011 Jun;11(6):426-37. doi: 10.1038/nrc3066. Epub 2011 May 12.

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• Sharma VK, Vouros P, Glick J. Mass spectrometric based analysis, characterization and applications of circulating cell free DNA isolated from human body fluids. Int J Mass Spectrom. 2011 Jul;304(2-3):172-183. doi: 10.1016/j.ijms.2010.10.003.

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• Son WY, Yoon SH, Yoon HJ, Lee SM, Lim JH. Pregnancy outcome following transfer of human blastocysts vitrified on electron microscopy grids after induced collapse of the blastocoele. Hum Reprod. 2003 Jan;18(1):137-9. doi: 10.1093/humrep/deg029.

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• Stigliani S, Anserini P, Venturini PL, Scaruffi P. Mitochondrial DNA content in embryo culture medium is significantly associated with human embryo fragmentation. Hum Reprod. 2013 Oct;28(10):2652-60. doi: 10.1093/humrep/det314. Epub 2013 Jul 25.

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• Stigliani S, Persico L, Lagazio C, Anserini P, Venturini PL, Scaruffi P. Mitochondrial DNA in Day 3 embryo culture medium is a novel, non-invasive biomarker of blastocyst potential and implantation outcome. Mol Hum Reprod. 2014 Dec;20(12):1238-46. doi: 10.1093/molehr/gau086. Epub 2014 Sep 17.

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• Traver S, Scalici E, Mullet T, Molinari N, Vincens C, Anahory T, Hamamah S. Cell-free DNA in Human Follicular Microenvironment: New Prognostic Biomarker to Predict in vitro Fertilization Outcomes. PLoS One. 2015 Aug 19;10(8):e0136172. doi: 10.1371/journal.pone.0136172. eCollection 2015.

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• Van Landuyt L, Polyzos NP, De Munck N, Blockeel C, Van de Velde H, Verheyen G. A prospective randomized controlled trial investigating the effect of artificial shrinkage (collapse) on the implantation potential of vitrified blastocysts. Hum Reprod. 2015 Nov;30(11):2509-18. doi: 10.1093/humrep/dev218. Epub 2015 Sep 12.

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• Vanderzwalmen P, Bertin G, Debauche Ch, Standaert V, van Roosendaal E, Vandervorst M, Bollen N, Zech H, Mukaida T, Takahashi K, Schoysman R. Births after vitrification at morula and blastocyst stages: effect of artificial reduction of the blastocoelic cavity before vitrification. Hum Reprod. 2002 Mar;17(3):744-51. doi: 10.1093/humrep/17.3.744.

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• Warton K, Samimi G. Methylation of cell-free circulating DNA in the diagnosis of cancer. Front Mol Biosci. 2015 Apr 22;2:13. doi: 10.3389/fmolb.2015.00013. eCollection 2015.

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• Wu CL, Li HG, Zhu CH. [Advances in the studies of cell-free seminal DNA]. Zhonghua Nan Ke Xue. 2013 Jul;19(7):652-6. Chinese.

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• Brouillet S, Gala A, Barry F, Anav M, Ferrieres-Hoa A, Andreeva A, Molinari N, Gaspari L, Loup V, Anahory T, Hamamah S. Artificial shrinkage before fresh blastocyst transfer and IVF outcomes: a pilot randomized controlled study. Reprod Biomed Online. 2024 Aug;49(2):103941. doi: 10.1016/j.rbmo.2024.103941. Epub 2024 Mar 8.

  PMID: 38824764 RESULT

Study Officials

• Anna AG GALA, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 9, 2016
• Study Start: May 20, 2018
• Primary Completion: August 20, 2021
• Study Completion: February 22, 2022
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)