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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04577560
Enrollment
10
Registered
2020-10-08
Start date
2021-06-06
Completion date
2022-01-01
Last updated
2021-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Telomere Length

Keywords

PGT-A, telomere length, cumulus cells, polar body

Brief summary

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

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.

Interventions

GENETICFirst 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.

GENETICPGT-A blastocyst

preimplantation genetic screening for aneuploidies

Sponsors

ART Fertility Clinics LLC
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)8 weeksCorrelation between telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)

Secondary

MeasureTime frameDescription
To correlate TL in male WBC and TL in sperm8 weeksTL will be assess in leukocytes (male´s blood sample) and in the sperm (fresh ejaculate)
To correlate TL in female WBC and TL in CC8 weeksTL will be assess in leukocytes (female´s blood sample) and in the cumulus cells (CC) from the retrieved oocytes.
To evaluate a possible correlation between TL-CC and TL-TE8 weeksCorrelation between TL-CC and TL in trophectoderm biopsy performed in the developed blastocysts
To evaluate a possible correlation between TL-CC and ploidy TE8 weeksCorrelation between TL-CC and PGT-A results in trophectoderm biopsy performed in the developed blastocysts
To correlate TL between both polar bodies8 weeksIf the MII fertilize after performing ICSI, polar body biopsy for the second PB will be performed
To evaluate FSH/LH gene expression in CC8 weeksDuring 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
To evaluate a possible correlation between ploidy in PBs and ploidy in TE biopsy8 weeksPGT-A in PB and PGT-A in TE biopsy
PB biopsy and embryo development8 weeksTo validate that PB biopsy does not impair embryo development compared to their sibling embryos with no PB biopsied
To evaluate TL in sperm + TL-PB and TL in TE8 weeksTL in sperm + TL-PB and TL in the resulting biopsied
To evaluate telomerase activity (TA) in CC and a possible correlation with CC-TL8 weeksTelomerase is a ribonucleoprotein complex responsible for de novo telomere synthesis and addition of telomeric repeats to existing telomeres

Countries

United Arab Emirates

Contacts

Primary ContactAna Arnanz Poyatos, MSc
ana.arnanz@artfertilityclinics.com+971563703889
Backup ContactNeelke DeMunck, PhD
neelke.demunck@artfertilityclinics.com+971501982760

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026