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

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05906966
• Other study ID #: 1234567
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• ART
• Child Development

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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