Cognitive, Emotional, Communicative, and Motor Development in Children Born From IOC

June 13, 2023 updated by: Istituto Clinico Humanitas

Cognitive, Emotional, Communicative, and Motor Development in Children Born From in Vitro Fertilization of Cryopreserved Oocytes

The study focuses on children born after in vitro fertilization (IVF) of cryopreserved oocytes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Evaluate whether the cognitive development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.
  • Evaluate whether the emotional development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.
  • Evaluate whether the communicative development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.
  • Evaluate whether the motor development of children born by IVF of cryopreserved oocytes is comparable to expected peer development

Study Type

Observational

Enrollment (Actual)

377

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

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Live births from pregnancies resulted from fresh and frozen embryo transfer after fertilization of cryopreserved oocytes are included.

Description

Inclusion Criteria:

  • Live births from pregnancies resulted from fresh and frozen embryo transfer after fertilization of cryopreserved oocytes are included.

Exclusion Criteria:

  • Children born from pregnancies obtained from cryopreserved donated oocytes have been excluded.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CHILDREN
BORN FROM IN VITRO FERTILIZATION OF CRYOPRESERVED OOCYTES
Other: Phone contact
. All mothers of children of born from cryopreserved oocytes will be contacted by phone and administered a questionnaire, to gather additional information about further psychomotor development of children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive development
Time Frame: 18 YEARS
Evaluation through a newly edited questionnaire according to milestones, set for age, established by CDC guidelines (Zubler et al, 2022). The objective is to compare cognitive development of children born by IVF of cryopreserved oocytes in comparison to expected peer development. Answers will be reported as yes/no according if milestones are achieved or not.
18 YEARS
Communicative development
Time Frame: 18 YEARS
Evaluation through a newly edited questionnaire according to milestones, set for age, established by CDC guidelines (Zubler et al, 2022). The objective is to compare communicative development of children born by IVF of cryopreserved oocytes in comparison to expected peer development. Answers will be reported as yes/no according if milestones are achieved or not.
18 YEARS
Motor development
Time Frame: 18 YEARS
Evaluation through a newly edited questionnaire according to milestones, set for age, established by CDC guidelines (Zubler et al, 2022). The objective is to compare motor development of children born by IVF of cryopreserved oocytes in comparison to expected peer development. Answers will be reported as yes/no according if milestones are achieved or not.
18 YEARS
Emotional development
Time Frame: 18 YEARS
Evaluation through a newly edited questionnaire according to milestones, set for age, established by CDC guidelines (Zubler et al, 2022). The objective is to compare emotional development of children born by IVF of cryopreserved oocytes in comparison to expected peer development. Answers will be reported as yes/no according if milestones are achieved or not.
18 YEARS

Collaborators and Investigators

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

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Paolo Emanuele Levi Setti, MD, Istituto Clinico Humanitas

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)

June 1, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Estimated)

June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1234567

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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