Importance of the Microtubule Cytoskeleton in Oocyte Competence

NCT04546412 | Completed

• 1 other identifier: 1907-LIS-072-AP
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess if there are microtubule cytoplasmic features specifically associated with oocyte vitrification.

Conditions

ART

Keywords

Oocyte competence; Oocyte vitrification; Cryobiology; Microtubule cytoskeleton

Outcome Measures

Primary Outcomes (1)

• Ocurrence of diferent features in the microtubule cytoskeleton

  Both fresh and vitrified-warmed oocytes will be analysed in respect to: spindle morphology; chromosome congression at the metáfase plate; presence of microtubule aggregates and presence of pericentriolar material aggregates.

  From October 2020 up to December 2020

Study Arms (2)

Fresh oocytes

Sibling oocytes not subjected to vitrification prior to assessment

Vitrified-thawed oocytes

Sibling oocytes subjected to vitrification using the Cryotop® - Open System and thawing prior to assessment

Device: Vitrification and thawing

Interventions

Vitrification and thawing DEVICE

Vitrification using the Cryotop® - Open System followed by thawing

Vitrified-thawed oocytes

Eligibility Criteria

• Age: 18 Years - 34 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy women who have consented to a cycle of fresh oocyte donation and who have a total antral-follicle count (AFC) above 20 at the onset of ovarian stimulation.

You may qualify if:

• Informed consent form dated and signed.
• Already consented to perform oocyte donation.
• Age ≥18 and \<35 years old.
• AFC ≥20.
• BMI ≥18.5 Kg/m2 and \<30 Kg/m2.
• Two ovaries present.
• No current pregnancy-wish.

You may not qualify if:

• Previous history of poor ovarian response (\<4 oocytes retrieved) with a maximal dose of ovarian stimulation (≥300 IU/day).
• Presence of a medical condition which is known to affect ART outcome (e.g. thyroid dysfunction).
• Active female smoking.
• Ongoing pregnancy.
• Current use of anti-depressants, anti-psychotics, steroids, antiepileptics or chemotherapy.
• Known allergy or hypersensitivity to any of the study non-IMP.

Sponsors & Collaborators

• Instituto Valenciano de Infertilidade de Lisboa: lead

Study Sites (1)

Instituto Valenciano de Infertilidade

Lisbon, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Consenting subjects will donate supernumerary mature oocytes for the study following exogenous ovarian stimulation. However, no genetic analyses will be performed.

Study Officials

• Sofia Nunes, PhD

  Instituto Valenciano de Infertilidade de Lisboa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: October 9, 2020
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)