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

NCT05502770 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2025-09-16

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

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.

OTHER

Physical development and General Health

Physical development and General health examination

DIAGNOSTIC_TEST

Developmental Red flags

Developmental Red flags Questionnaires

Sponsors & Collaborators

  • Mỹ Đức Hospital

    lead OTHER

Principal Investigators

  • Lan N Vuong · University of Medicine and Pharmacy at Ho Chi Minh City

Eligibility

Min Age
6 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-12
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Vietnam

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05502770 on ClinicalTrials.gov