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

Mỹ Đức Hospital

Status: Enrolling

Conditions: Child Development; Endometrial Preparation

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

Study type: Observational

Funder types: Other

Identifiers

NCT05502770

09/22/DD-BVMD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 6 to 18 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

700 participants in 3 patient groups

Natural cycle children

Description:

Children born from frozen embryo transfer with natural cycle protocol

Treatment:

Other: Physical development and General Health

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

Diagnostic Test: Developmental Red flags

Modified natural cycle children

Description:

Children born from frozen embryo transfer with modified natural cycle protocol

Treatment:

Other: Physical development and General Health

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

Diagnostic Test: Developmental Red flags

Artificial cycle children

Description:

Children born from frozen embryo transfer with artificial cycle protocol

Treatment:

Other: Physical development and General Health

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

Diagnostic Test: Developmental Red flags