NCT03860064

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

March 27, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 19, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

February 27, 2019

Last Update Submit

November 18, 2019

Conditions

Aneuploidy

Outcome Measures

Primary Outcomes (1)

  • Aneuploidy rate

    Aneuploidy rate of the PB

    The moment that the PB is extruded (between 1 hour and 50 hours after the denudation)

Interventions

Non interventionOTHER

Non

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivi Barcelona

Barcelona, 08017, Spain

Location

MeSH Terms

Conditions

Aneuploidy

Condition Hierarchy (Ancestors)

Chromosome AberrationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 1, 2019

Study Start

March 27, 2019

Primary Completion

July 30, 2019

Study Completion

September 30, 2019

Last Updated

November 19, 2019

Record last verified: 2019-07

Locations

ES(1)