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

Completed

• Conditions: ART; Child Development
• Interventions: Other: Phone contact

• Registration Number: NCT05906966
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-03-31
• Status Verified: 2023-06
• Study Start: 2023-06-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Study First Submitted QC: 2023-06-13
• Last Update Submitted: 2023-06-13
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHILDREN	Phone contact	BORN FROM IN VITRO FERTILIZATION OF CRYOPRESERVED OOCYTES

Primary Outcome Measures

Name	Time	Method
Motor development	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.
Cognitive development	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.
Communicative development	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.
Emotional development	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.

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy