Telomere Length in Human Polar Body and Telomere Length in Cumulus Cells: A Clinical Validation Study

June 8, 2021 updated by: Ana Arnanz, ART Fertility Clinics LLC

Does the Telomere Length in First Human Polar Body Correlates With the Telomere Length in Cumulus Cells: A Clinical Validation Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

With the present study we want to analyze, as a primary objective, whether telomere length (TL) in the first Polar Body (PB) correlates with TL in the corresponding Cumulus cells (CC). As a secondary objective, a possible correlation between TL in PBs and blastocyst TL and ploidy will be evaluated.

To our best knowledge, there are no studies evaluating TL in CC and TL in PBs of the corresponding oocyte. With the present prospective study, we sought to investigate whether there is a correlation between CC-TL and PB-TL. If a correlation exists, CC-TL assessment would serve as a valuable non-invasive technique to gain information about oocyte competence.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MII with PB biopsy
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 oocytes
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.
Other Names:
  • telomere lenght
Genetic: PGT-A blastocyst
preimplantation genetic screening for aneuploidies
EXPERIMENTAL: MII with no PB biopsy
MII will not go under polar body biopsy. On day 5, 6 or 7, the resulting blastocyst will be biopsied.
Genetic: PGT-A blastocyst
preimplantation genetic screening for aneuploidies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)
Time Frame: 8 weeks
Correlation between telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To correlate TL between both polar bodies
Time Frame: 8 weeks
If the MII fertilize after performing ICSI, polar body biopsy for the second PB will be performed
8 weeks
To correlate TL in male WBC and TL in sperm
Time Frame: 8 weeks
TL will be assess in leukocytes (male´s blood sample) and in the sperm (fresh ejaculate)
8 weeks
To correlate TL in female WBC and TL in CC
Time Frame: 8 weeks
TL will be assess in leukocytes (female´s blood sample) and in the cumulus cells (CC) from the retrieved oocytes.
8 weeks
To evaluate a possible correlation between TL-CC and TL-TE
Time Frame: 8 weeks
Correlation between TL-CC and TL in trophectoderm biopsy performed in the developed blastocysts
8 weeks
To evaluate a possible correlation between TL-CC and ploidy TE
Time Frame: 8 weeks
Correlation between TL-CC and PGT-A results in trophectoderm biopsy performed in the developed blastocysts
8 weeks
To evaluate telomerase activity (TA) in CC and a possible correlation with CC-TL
Time Frame: 8 weeks
Telomerase is a ribonucleoprotein complex responsible for de novo telomere synthesis and addition of telomeric repeats to existing telomeres
8 weeks
To evaluate FSH/LH gene expression in CC
Time Frame: 8 weeks
During the follicular phase LH whose receptors (LHR) are expressed in granulosa cells under the influence of FSH, plays an important role in the regulation of ovarian function and is essential to promote the growth of the dominant follicle, final oocyte maturation as well as ovulation induction
8 weeks
To evaluate a possible correlation between ploidy in PBs and ploidy in TE biopsy
Time Frame: 8 weeks
PGT-A in PB and PGT-A in TE biopsy
8 weeks
PB biopsy and embryo development
Time Frame: 8 weeks
To validate that PB biopsy does not impair embryo development compared to their sibling embryos with no PB biopsied
8 weeks
To evaluate TL in sperm + TL-PB and TL in TE
Time Frame: 8 weeks
TL in sperm + TL-PB and TL in the resulting biopsied
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Ana Arnanz Poyatos, MSc, ART Fertility Clinics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 6, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (ACTUAL)

October 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2006-ABU-007-AA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

From March 2021

IPD Sharing Access Criteria

pubmed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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