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

NCT ID: NCT05502770

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-12

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Developing further from a previous randomized controlled clinical trial (MONART study - NCT04804020), the investigators decided to assess the physical, mental, and motor development of children up to 24 months after birth, with the aim of providing additional information on the safety of these regimens on the long-term health of the IVF/ICSI children.

Conditions

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Child Development Endometrial Preparation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Natural cycle children

Children born from frozen embryo transfer with natural cycle protocol

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

Intervention Type 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.

Physical development and General Health

Intervention Type OTHER

Physical development and General health examination

Developmental Red flags

Intervention Type DIAGNOSTIC_TEST

Developmental Red flags Questionnaires

Modified natural cycle children

Children born from frozen embryo transfer with modified natural cycle protocol

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

Intervention Type 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.

Physical development and General Health

Intervention Type OTHER

Physical development and General health examination

Developmental Red flags

Intervention Type DIAGNOSTIC_TEST

Developmental Red flags Questionnaires

Artificial cycle children

Children born from frozen embryo transfer with artificial cycle protocol

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

Intervention Type 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.

Physical development and General Health

Intervention Type OTHER

Physical development and General health examination

Developmental Red flags

Intervention Type DIAGNOSTIC_TEST

Developmental Red flags Questionnaires

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Physical development and General Health

Physical development and General health examination

Intervention Type OTHER

Developmental Red flags

Developmental Red flags Questionnaires

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Babies died under or at 24 months
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mỹ Đức Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lan N Vuong

Role: STUDY_CHAIR

University of Medicine and Pharmacy at Ho Chi Minh City

Locations

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My Duc Hospital

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Hieu LT Hoang

Role: CONTACT

(+84) 969 166 318

Vu NA Ho

Role: CONTACT

(+84) 935 843 336

Facility Contacts

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Hieu LT Hoang, MD

Role: primary

(+84) 969 166 318

Other Identifiers

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09/22/DD-BVMD

Identifier Type: -

Identifier Source: org_study_id

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