Aneuploidy Rates of in Vitro Matured Oocytes (IVM)

November 18, 2019 updated by: IVI Barcelona

In general, nearly 85% of retrieved oocytes are mature and reproductively useful after the retrieval, whereas the remaining percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %, respectively).

The objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Under controlled ovarian stimulation, patients with normal functional ovarian reserves produce a good number of oocytes at retrieval. However, in addition to quantity, oocyte maturity is an important variable for the success of reproductive technologies. In general, nearly 85% of retrieved oocytes are mature and reproductively useful, whereas the remaining percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %, respectively). Due to the limited expectations held for in vitro maturation in said stimulated cycles, the rescue of immature oocytes is not widely used in current clinical practice and these oocytes are usually discarded due to the possibility of abnormal embryonic development or an increased rate of abortion.

The objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08017
        • IVI Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Mature ooocytes from the same donors, will be used as control group.

Description

Inclusion Criteria:

  • 18-35-year-old women
  • BMI: >18 and < 30 kg/m2
  • Normal female karyotype
  • Normal uterus and ovaries at transvaginal ultrasound

Exclusion Criteria:

  • > 35 years
  • PCO syndrome carriers
  • Null follicle aspiration
  • History of chemotherapy or radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aneuploidy rate
Time Frame: The moment that the PB is extruded (between 1 hour and 50 hours after the denudation)
Aneuploidy rate of the PB
The moment that the PB is extruded (between 1 hour and 50 hours after the denudation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2019

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

February 27, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1810-BCN-071-ME

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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