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

ART Fertility Clinics LLC

Status: Unknown

Conditions: Telomere Length

Treatments: Genetic: First polar body biopsy in MII oocytes; Genetic: PGT-A blastocyst

Study type: Interventional

Funder types: Other

Identifiers

NCT04577560

2006-ABU-007-AA

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

MII with PB biopsy

Experimental group

Description:

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.

Treatment:

Genetic: PGT-A blastocyst

Genetic: First polar body biopsy in MII oocytes

MII with no PB biopsy

Experimental group

Description:

MII will not go under polar body biopsy. On day 5, 6 or 7, the resulting blastocyst will be biopsied.

Treatment:

Genetic: PGT-A blastocyst