NCT04577560

Brief Summary

To investigate whether telomere length (TL) of the first Polar body (PB) correlates with TL in Cumulus cells (CC)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

June 6, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

September 30, 2020

Last Update Submit

June 8, 2021

Conditions

Telomere Length

Keywords

PGT-Atelomere lengthcumulus cellspolar body

Outcome Measures

Primary Outcomes (1)

  • telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)

    Correlation between telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)

    8 weeks

Secondary Outcomes (10)

  • To correlate TL between both polar bodies

    8 weeks

  • To correlate TL in male WBC and TL in sperm

    8 weeks

  • To correlate TL in female WBC and TL in CC

    8 weeks

  • To evaluate a possible correlation between TL-CC and TL-TE

    8 weeks

  • To evaluate a possible correlation between TL-CC and ploidy TE

    8 weeks

  • +5 more secondary outcomes

Study Arms (2)

MII with PB biopsy

EXPERIMENTAL

Five selected MII will undergo sequential polar biopsy; on day 0 \[PB1\] (36-42 hours post trigger injection) and if fertilization occurred on day 1 \[PB2\] (17-20 hours post ICSI). On day 5, 6 or 7, the resulting blastocyst will be biopsied.

Genetic: First polar body biopsy in MII oocytesGenetic: PGT-A blastocyst

MII with no PB biopsy

EXPERIMENTAL

MII will not go under polar body biopsy. On day 5, 6 or 7, the resulting blastocyst will be biopsied.

Genetic: PGT-A blastocyst

Interventions

First polar body biopsy in MII oocytesGENETIC

Since PBs are by-products of the meiotic division of the oocyte and are not required for fertilization and subsequent embryo development, they can be removed to assess exclusively maternal chromosomal information without harming the embryo integrity. As previously described, PB biopsy does not impact the morphokinetic parameters of the embryo development and can be safely applied without the risk of impairing the reproductive potential of the embryo.

Also known as: telomere lenght
MII with PB biopsy
PGT-A blastocystGENETIC

preimplantation genetic screening for aneuploidies

MII with PB biopsyMII with no PB biopsy

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18- 30kg/m2
  • Expected normo/high responders
  • Normal female/male karyotype
  • Antagonist protocol with agonist trigger.
  • PGT-A: NGS in blastocysts
  • Fresh autologous ejaculates (≥5 mill/ml)
  • Primary and secondary infertility
  • Only ICSI as insemination technique

You may not qualify if:

  • PCOS patients according to International evidence-based guideline for the assessment and management of polycystic ovarian syndrome 2018.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ART Fertility Clinics

Abu Dhabi, United Arab Emirates

RECRUITING

Related Publications (11)

  • Kosebent EG, Uysal F, Ozturk S. Telomere length and telomerase activity during folliculogenesis in mammals. J Reprod Dev. 2018 Dec 14;64(6):477-484. doi: 10.1262/jrd.2018-076. Epub 2018 Sep 28.

    PMID: 30270279RESULT

  • Ozturk S. Telomerase activity and telomere length in male germ cells. Biol Reprod. 2015 Feb;92(2):53. doi: 10.1095/biolreprod.114.124008. Epub 2015 Jan 7.

    PMID: 25568305RESULT

  • Riethman H, Ambrosini A, Paul S. Human subtelomere structure and variation. Chromosome Res. 2005;13(5):505-15. doi: 10.1007/s10577-005-0998-1.

    PMID: 16132815RESULT

  • Keefe DL, Marquard K, Liu L. The telomere theory of reproductive senescence in women. Curr Opin Obstet Gynecol. 2006 Jun;18(3):280-5. doi: 10.1097/01.gco.0000193019.05686.49.

    PMID: 16735827RESULT

  • Kidder GM, Vanderhyden BC. Bidirectional communication between oocytes and follicle cells: ensuring oocyte developmental competence. Can J Physiol Pharmacol. 2010 Apr;88(4):399-413. doi: 10.1139/y10-009.

    PMID: 20555408RESULT

  • Cheng EH, Chen SU, Lee TH, Pai YP, Huang LS, Huang CC, Lee MS. Evaluation of telomere length in cumulus cells as a potential biomarker of oocyte and embryo quality. Hum Reprod. 2013 Apr;28(4):929-36. doi: 10.1093/humrep/det004. Epub 2013 Feb 1.

    PMID: 23377770RESULT

  • Lara-Molina EE, Franasiak JM, Marin D, Tao X, Diaz-Gimeno P, Florensa M, Martin M, Seli E, Pellicer A. Cumulus cells have longer telomeres than leukocytes in reproductive-age women. Fertil Steril. 2020 Jan;113(1):217-223. doi: 10.1016/j.fertnstert.2019.08.089. Epub 2019 Oct 6.

    PMID: 31594634RESULT

  • Wang W, Chen H, Li R, Ouyang N, Chen J, Huang L, Mai M, Zhang N, Zhang Q, Yang D. Telomerase activity is more significant for predicting the outcome of IVF treatment than telomere length in granulosa cells. Reproduction. 2014 Apr 8;147(5):649-57. doi: 10.1530/REP-13-0223. Print 2014 May.

    PMID: 24472817RESULT

  • Montag M, Koster M, Strowitzki T, Toth B. Polar body biopsy. Fertil Steril. 2013 Sep;100(3):603-7. doi: 10.1016/j.fertnstert.2013.05.053. Epub 2013 Jun 21.

    PMID: 23796365RESULT

  • Treff NR, Su J, Taylor D, Scott RT Jr. Telomere DNA deficiency is associated with development of human embryonic aneuploidy. PLoS Genet. 2011 Jun;7(6):e1002161. doi: 10.1371/journal.pgen.1002161. Epub 2011 Jun 30.

    PMID: 21738493RESULT

  • Schenk M, Groselj-Strele A, Eberhard K, Feldmeier E, Kastelic D, Cerk S, Weiss G. Impact of polar body biopsy on embryo morphokinetics-back to the roots in preimplantation genetic testing? J Assist Reprod Genet. 2018 Aug;35(8):1521-1528. doi: 10.1007/s10815-018-1207-4. Epub 2018 May 22.

    PMID: 29790071RESULT

Study Officials

  • Ana Arnanz Poyatos, MSc

    ART Fertility Clinics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Arnanz Poyatos, MSc

CONTACT

+971563703889ana.arnanz@artfertilityclinics.com

Neelke DeMunck, PhD

CONTACT

+971501982760neelke.demunck@artfertilityclinics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 8, 2020

Study Start

June 6, 2021

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

June 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
From March 2021
Access Criteria
pubmed
More information

Locations

AE(1)