Clinical trial NCT04577560: Telomere Length in Human Polar Body and Telomere Length in Cumulus Cells: A Clinical Validation Study
Official title: Does the Telomere Length in First Human Polar Body Correlates With the Telomere Length in Cumulus Cells: A Clinical Validation Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Telomere Length
Keywords: PGT-A
telomere length
cumulus cells
polar body
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)
timeFrame: 8 weeks
Secondary outcomes:
measure: To correlate TL between both polar bodies
timeFrame: 8 weeks
measure: To correlate TL in male WBC and TL in sperm
timeFrame: 8 weeks
measure: To correlate TL in female WBC and TL in CC
timeFrame: 8 weeks
measure: To evaluate a possible correlation between TL-CC and TL-TE
timeFrame: 8 weeks
measure: To evaluate a possible correlation between TL-CC and ploidy TE
timeFrame: 8 weeks
measure: To evaluate telomerase activity (TA) in CC and a possible correlation with CC-TL
timeFrame: 8 weeks
measure: To evaluate FSH/LH gene expression in CC
timeFrame: 8 weeks
measure: To evaluate a possible correlation between ploidy in PBs and ploidy in TE biopsy
timeFrame: 8 weeks
measure: PB biopsy and embryo development
timeFrame: 8 weeks
measure: To evaluate TL in sperm + TL-PB and TL in TE
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics
Study officials:
affiliation: ART Fertility Clinics
name: Ana Arnanz Poyatos, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.