AzTrials
AzTrials

Infertility Assisted Reproductive TechnologyBlastoCollapseNCT02988544

Artificial Shrinkage of Fresh Blastocysts

A study testing Artificial shrinkage in people with Infertility Assisted Reproductive Technology, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 43 years, women only
What is being tested?
Artificial shrinkage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteFrance
Study dates
20 May 2018to 22 Feb 2022
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 43 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • Attempt with frozen embryo or frozen oocyte
  • Attempt with a pre-implantation diagnosis
  • Patient has not signed informed consent
  • Couple in a period of exclusion determined by a previous study
  • Couple under legal protection, guardianship or guardianship

Trial locations and contacts

1 site in 1 country.

France1 site

  • Montpellier University Hospital

    Montpellier, 34295

Other trials in France

About this study

Official title: Artificial Shrinkage of Fresh Blastocyst: Impact on Success Rates in Assisted Reproductive Technology

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.

Read the detailed description

This is a prospective randomized study designed to determine if artificial shrinkage (AS) before transfer of embryos impact clinical pregnancy rate in single blastocyst embryo transfer (SBET) cycle. Women elected for SBET will be randomized on transfer day in two arms:the AS group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer and a control group.

Clinical pregnancy rates will be compared. Secondarily, rate of monozygotic twin pregnancy and cell free DNA concentration in culture medium will be evaluated in the two groups.

Being tested
Artificial shrinkage
Keywords
Single blastocyst embryo transfer, Artificial Shrinkage, Clinical pregnancy rate, Cell free

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial shrinkageProcedure or surgery

    Artificial shrinkage of blastocyst

Study groups in NCT02988544
Study groupRoleWhat they receive
Artificial shrinkage (AS) groupExperimentalThe Artificial shrinkage group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer
Receives: Procedure: Artificial shrinkage
Control groupNo interventionNo intervention on blastocoelic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 weeks

Secondary outcomes (2)

  1. Twin pregnancy rate by transfer

    Twin pregnancy rate by transfer evaluate the presence of 2 cardiac activities on ultrasound.

    Measured: 5 weeks

  2. Free DNA level

    Free DNA content contained in the drop of culture medium collected after transfer.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2016 (estimated)
  2. Study start20 May 2018
  3. Primary completion20 Aug 2021
  4. Study completion22 Feb 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02988544
Sponsor's protocol ID
RECHMPL16_0267
Acronym
BlastoCollapse
Status last verified
Oct 2026
First submitted
2 Dec 2016
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23182744

  • 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.

    PubMed 22020776

  • Fanchin R, Ayoubi JM. Uterine dynamics: impact on the human reproduction process. Reprod Biomed Online. 2009;18 Suppl 2:57-62. doi: 10.1016/s1472-6483(10)60450-6.

    PubMed 19406033

  • 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.

    PubMed 25442824

  • 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.

    PubMed 25256935

  • 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.

    PubMed 21042844

  • 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.

    PubMed 22384424

  • 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.

    PubMed 21152966

  • 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.

    PubMed 26174844

  • 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.

    PubMed 21215395

  • 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.

    PubMed 18190376

  • 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.

    PubMed 11576729

  • 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.

    PubMed 18875018

  • 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.

    PubMed 23557766

  • 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.

    PubMed 25267787

Questions about this trial

What is this clinical trial studying?

A study testing Artificial shrinkage in people with Infertility Assisted Reproductive Technology, run by University Hospital, Montpellier at 1 site in France.

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 2 inclusion and 5 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: finished, as of the sponsor's last update on 27 Oct 2026. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Clinical pregnancy rate embryo transfer (time frame: 5 weeks). 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 NCT02988544, which also lists 27 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 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in