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

• Sponsor: Istituto Clinico Humanitas (Other)
• Overall Status: Completed
• CT.gov ID: NCT05906966
• Collaborator: (none)
• Enrollment: 377
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
ART; Child Development	Other: Phone contact

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 Design

• Study Type: Observational
• Actual Enrollment: 377 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Cognitive, Emotional, Communicative, and Motor Development in Children Born From in Vitro Fertilization of Cryopreserved Oocytes
• Actual Study Start Date: Jun 1, 2023
• Actual Primary Completion Date: Jun 1, 2023
• Actual Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Clinico Humanitas	Rozzano	Milano	Italy	20089

Sponsors and Collaborators

• Istituto Clinico Humanitas

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istituto Clinico Humanitas
• ClinicalTrials.gov Identifier: NCT05906966
• Other Study ID Numbers: 1234567
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 18, 2023