Telomere LengthNCT04577560
Telomere Length in Human Polar Body and Telomere Length in Cumulus Cells: A Clinical Validation Study
A study testing First polar body biopsy in MII oocytes and PGT-A blastocyst in people with Telomere Length, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
To investigate whether telomere length (TL) of the first Polar body (PB) correlates with TL in Cumulus cells (CC) Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Telomere Length
- What is being tested?
- First polar body biopsy in MII oocytes and PGT-A blastocyst
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 6 Jun 2021to 1 Jan 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- PCOS patients according to International evidence-based guideline for the assessment and management of polycystic ovarian syndrome 2018.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
ART Fertility Clinics
Abu Dhabi
Neelke De Munck, PhD, +971501982760, Neelke.demunck@artfertilityclinics.com
Barbara Lawrenz, PhD, MD, +971526500757, Barbara.Lawrenz@artfertilityclinics.com
About this study
Official title: 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)
Read the 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.
- Conditions
- Telomere Length
- Being tested
- First polar body biopsy in MII oocytes, PGT-A blastocyst
- Keywords
- PGT-A, telomere length, cumulus cells, polar body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First polar body biopsy in MII oocytesGenetic
Also called telomere lenght
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.
PGT-A blastocystGenetic
preimplantation genetic screening for aneuploidies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: First polar body biopsy in MII oocytes; Genetic: 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. Receives: Genetic: PGT-A blastocyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks
Secondary outcomes (10)
To correlate TL between both polar bodies
If the MII fertilize after performing ICSI, polar body biopsy for the second PB will be performed
Measured: 8 weeks
To correlate TL in male WBC and TL in sperm
TL will be assess in leukocytes (male´s blood sample) and in the sperm (fresh ejaculate)
Measured: 8 weeks
To correlate TL in female WBC and TL in CC
TL will be assess in leukocytes (female´s blood sample) and in the cumulus cells (CC) from the retrieved oocytes.
Measured: 8 weeks
To evaluate a possible correlation between TL-CC and TL-TE
Correlation between TL-CC and TL in trophectoderm biopsy performed in the developed blastocysts
Measured: 8 weeks
To evaluate a possible correlation between TL-CC and ploidy TE
Correlation between TL-CC and PGT-A results in trophectoderm biopsy performed in the developed blastocysts
Measured: 8 weeks
To evaluate telomerase activity (TA) in CC and a possible correlation with CC-TL
Telomerase is a ribonucleoprotein complex responsible for de novo telomere synthesis and addition of telomeric repeats to existing telomeres
Measured: 8 weeks
To evaluate FSH/LH gene expression in CC
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
Measured: 8 weeks
To evaluate a possible correlation between ploidy in PBs and ploidy in TE biopsy
PGT-A in PB and PGT-A in TE biopsy
Measured: 8 weeks
PB biopsy and embryo development
To validate that PB biopsy does not impair embryo development compared to their sibling embryos with no PB biopsied
Measured: 8 weeks
To evaluate TL in sperm + TL-PB and TL in TE
TL in sperm + TL-PB and TL in the resulting biopsied
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start6 Jun 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Telomere LengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Arnanz, ART Fertility Clinics LLC
- Investigators
- Ana Arnanz Poyatos, MSc, Principal investigator, ART Fertility Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577560
- Sponsor's protocol ID
- 2006-ABU-007-AA
- Status last verified
- Jun 2021
- First submitted
- 30 Sep 2020
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 30270279Ozturk 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.
PubMed 25568305Riethman H, Ambrosini A, Paul S. Human subtelomere structure and variation. Chromosome Res. 2005;13(5):505-15. doi: 10.1007/s10577-005-0998-1.
PubMed 16132815Keefe 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.
PubMed 16735827Kidder 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.
PubMed 20555408Cheng 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.
PubMed 23377770Lara-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.
PubMed 31594634Wang 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.
PubMed 24472817Montag 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.
PubMed 23796365Treff 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.
PubMed 21738493Schenk 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.
PubMed 29790071
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Telomere Length in First Human Polar Body Correlates With the Telomere Length in Cumulus Cells: A Clinical Validation Study
- ClinicalTrials.gov ID
- NCT04577560
- Acronym / sponsor ID
- 2006-ABU-007-AA
- Conditions
- Telomere Length
- Keywords
- PGT-A, telomere length, cumulus cells, polar body
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MII with PB biopsy | Experimental | Genetic: First polar body biopsy in MII oocytes, Genetic: PGT-A blastocystFive 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. |
| MII with no PB biopsy | Experimental | Genetic: PGT-A blastocystMII will not go under polar body biopsy. On day 5, 6 or 7, the resulting blastocyst will be biopsied. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- BMI 18- 30kg/m2
- Expected normo/high responders
- Normal female/male karyotype
- Antagonist protocol with agonist trigger.
- PGT-A: NGS in blastocysts
Key exclusion criteria (1 listed)
- PCOS patients according to International evidence-based guideline for the assessment and management of polycystic ovarian syndrome 2018.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First polar body biopsy in MII oocytesAlso: telomere lenghtSince 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. | Genetic | MII with PB biopsy |
| PGT-A blastocystpreimplantation genetic screening for aneuploidies | Genetic | MII with PB biopsy, MII with no PB biopsy |
Primary outcome
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)
10 secondary outcomes
To correlate TL between both polar bodies
Time frame: 8 weeks
To correlate TL in male WBC and TL in sperm
Time frame: 8 weeks
To correlate TL in female WBC and TL in CC
Time frame: 8 weeks
To evaluate a possible correlation between TL-CC and TL-TE
Time frame: 8 weeks
To evaluate a possible correlation between TL-CC and ploidy TE
Time frame: 8 weeks
To evaluate telomerase activity (TA) in CC and a possible correlation with CC-TL
Time frame: 8 weeks
To evaluate FSH/LH gene expression in CC
Time frame: 8 weeks
To evaluate a possible correlation between ploidy in PBs and ploidy in TE biopsy
Time frame: 8 weeks
PB biopsy and embryo development
Time frame: 8 weeks
To evaluate TL in sperm + TL-PB and TL in TE
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Results publication: PubMed 30270279Kosebent 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.
- Results publication: PubMed 25568305Ozturk 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.
- Results publication: PubMed 16132815Riethman H, Ambrosini A, Paul S. Human subtelomere structure and variation. Chromosome Res. 2005;13(5):505-15. doi: 10.1007/s10577-005-0998-1.
- Results publication: PubMed 16735827Keefe 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.
- Results publication: PubMed 20555408Kidder 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.
- Results publication: PubMed 23377770Cheng 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.
- Results publication: PubMed 31594634Lara-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.
- Results publication: PubMed 24472817Wang 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.
- Results publication: PubMed 23796365Montag 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.
- Results publication: PubMed 21738493Treff 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.
- Results publication: PubMed 29790071Schenk 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Arnanz Poyatos, MSc principal investigator
ART Fertility Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First polar body biopsy in MII oocytes and PGT-A blastocyst in people with Telomere Length, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
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 8 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jun 2021. 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 United Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Arnanz Poyatos, MSc (+971563703889 ext. 1007, ana.arnanz@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC) (time frame: 8 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 NCT04577560, which also lists 11 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 9 Jun 2021.