Development of IVF/ICSI Children Born From Different Endometrial Preparation Protocols

NCT05502770 | Recruiting DMC

• 1 other identifier: 09/22/DD-BVMD
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy and safety of endometrial preparation regimens remain controversial. In the most recent meta-analysis, using natural and modified natural cycle protocol to prepare the endometrium in frozen embryo transfer resulted in higher live birth rates. In addition, the natural cycle reduces the risk of gestational hypertension, postpartum haemorrhage, and extremely preterm delivery compared with regimens using exogenous hormones. Because there are many physiological and endocrinal differences in the frozen embryo transfer cycle with different endometrial preparation protocols, the development of children born from these regimens has received much attention. For example, there is a complete absence of the corpus luteum during the cycle of exogenous hormone administration. Or in the modified natural cycle, the pharmacokinetics is not entirely the same as the natural physiology when using an additional ovulatory injection with hCG. To date, there have been no longitudinal follow-up studies that evaluated and compared the long-term development of IVF/ICSI children born from frozen embryo transfer with different endometrial preparation protocols. Thus, the investigators conduct a follow-up of our RCT to investigate the IVF/ICSI children born from frozen embryo transfer with different endometrial preparation protocols to give strong evidence about the safety of the three most common endometrial preparation protocols in women undergoing frozen embryo transfer.

Conditions

Child Development; Endometrial Preparation

Keywords

Child development; Endometrial preparation; IVF/ICSI; Natural cycle; Modified natural cycle; Artificial cycle

Outcome Measures

Primary Outcomes (1)

• The average total ASQ-3 score

  ASQ-3 (Ages and Stages Questionaires®) has 5 aspects: Communication, Gross motor, Fine motor, Problem solving and Personal-Social Each aspect has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. ASQ-3 average = average score of 5 aspects.

  Up to 24 months after birth

Secondary Outcomes (6)

• Score of Communication

  Up to 24 months after birth

• Score of Gross motor

  Up to 24 months after birth

• Score of Fine motor

  Up to 24 months after birth

• Score of Problem solving

  Up to 24 months after birth

• Score of Personal-Social

  Up to 24 months after birth

Study Arms (3)

Natural cycle children

Children born from frozen embryo transfer with natural cycle protocol

Diagnostic Test: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Other: Physical development and General Health; Diagnostic Test: Developmental Red flags

Modified natural cycle children

Children born from frozen embryo transfer with modified natural cycle protocol

Diagnostic Test: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Other: Physical development and General Health; Diagnostic Test: Developmental Red flags

Artificial cycle children

Children born from frozen embryo transfer with artificial cycle protocol

Diagnostic Test: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Other: Physical development and General Health; Diagnostic Test: Developmental Red flags

Interventions

Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 DIAGNOSTIC_TEST

Ages \& Stages Questionnaires®, Third Edition (ASQ®-3) is a developmental screening tool designed for use by early educators and health care professionals. It relies on parents as experts, is easy-to-use, family-friendly and creates the snapshot needed to catch delays and celebrate milestones.

Artificial cycle children; Modified natural cycle children; Natural cycle children

Physical development and General Health OTHER

Physical development and General health examination

Artificial cycle children; Modified natural cycle children; Natural cycle children

Developmental Red flags DIAGNOSTIC_TEST

Developmental Red flags Questionnaires

Artificial cycle children; Modified natural cycle children; Natural cycle children

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Live IVF/ICSI babies born from frozen embryo transfer following the natural cycle, modified natural cycle, and artificial cycle from MONART study (NCT04804020)

You may qualify if:

• All live IVF/ICSI babies born from frozen embryo transfer following the natural cycle, modified natural cycle, and artificial cycle from MONART study
• Parents agree to participate in the study.

You may not qualify if:

• Babies died under or at 24 months

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, 70000, Vietnam

RECRUITING

MeSH Terms

Interventions

Health Status

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Lan N Vuong

  University of Medicine and Pharmacy at Ho Chi Minh City

  STUDY CHAIR

Central Study Contacts

Hieu LT Hoang

CONTACT

(+84) 969 166 318; bshieu.hlt@gmail.com

Vu NA Ho

CONTACT

(+84) 935 843 336; bsvu.hna@myduchospital.vn

Study Design

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

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 16, 2022
• Study Start: August 12, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

VN (1)