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

Not Applicable

• Conditions: Telomere Length
• Interventions: Genetic: First polar body biopsy in MII oocytes; Genetic: PGT-A blastocyst

• Registration Number: NCT04577560
• Lead Sponsor: ART Fertility Clinics LLC

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.

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-08
• Status Verified: 2021-06
• Study Start: 2021-06-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-09
• Primary Completion: 2021-12-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MII with PB biopsy	PGT-A blastocyst	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.
MII with PB biopsy	First polar body biopsy in MII oocytes	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.
MII with no PB biopsy	PGT-A blastocyst	MII will not go under polar body biopsy. On day 5, 6 or 7, the resulting blastocyst will be biopsied.

Primary Outcome Measures

Name	Time	Method
telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)	8 weeks	Correlation between telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)

Secondary Outcome Measures

Name	Time	Method
To evaluate a possible correlation between TL-CC and ploidy TE	8 weeks	Correlation between TL-CC and PGT-A results in trophectoderm biopsy performed in the developed blastocysts
To correlate TL between both polar bodies	8 weeks	If the MII fertilize after performing ICSI, polar body biopsy for the second PB will be performed
To evaluate telomerase activity (TA) in CC and a possible correlation with CC-TL	8 weeks	Telomerase is a ribonucleoprotein complex responsible for de novo telomere synthesis and addition of telomeric repeats to existing telomeres
To evaluate FSH/LH gene expression in CC	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
To evaluate a possible correlation between ploidy in PBs and ploidy in TE biopsy	8 weeks	PGT-A in PB and PGT-A in TE biopsy
To evaluate TL in sperm + TL-PB and TL in TE	8 weeks	TL in sperm + TL-PB and TL in the resulting biopsied
To correlate TL in male WBC and TL in sperm	8 weeks	TL will be assess in leukocytes (male´s blood sample) and in the sperm (fresh ejaculate)
To correlate TL in female WBC and TL in CC	8 weeks	TL 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-TE	8 weeks	Correlation between TL-CC and TL in trophectoderm biopsy performed in the developed blastocysts
PB biopsy and embryo development	8 weeks	To validate that PB biopsy does not impair embryo development compared to their sibling embryos with no PB biopsied

Trial Locations

Locations (1)

ART Fertility Clinics; 🇦🇪 Abu Dhabi, United Arab Emirates