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

NCT05906966 | Completed

• 1 other identifier: 1234567
• Study Type: observational
• Target: 377
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ART; Child Development

Outcome Measures

Primary Outcomes (4)

• Cognitive development

  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

  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

  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

  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

Study Arms (1)

CHILDREN

BORN FROM IN VITRO FERTILIZATION OF CRYOPRESERVED OOCYTES

Other: Phone contact

Interventions

Phone contact OTHER

. 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.

CHILDREN

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Study Officials

• Paolo Emanuele Levi Setti, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: June 18, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

IT (1)