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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorMỹ Đức Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Babies died under or at 24 months

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • Physical development and General Health

    Other intervention

    Physical development and General health examination

  • Developmental Red flags

    Diagnostic test

    Developmental Red flags Questionnaires

Treatment groups

700 Participants
are divided into 3 treatment groups
Group A: Natural cycle children3 interventions
Group B: Modified natural cycle children3 interventions
Group C: Artificial cycle children3 interventions

Trial outcomes

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.

Time frame
Up to 24 months after birth

Secondary outcomes

1

Score of Communication

6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold

Time frame
Up to 24 months after birth
2

Score of Gross motor

6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold

Time frame
Up to 24 months after birth
3

Score of Fine motor

6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold

Time frame
Up to 24 months after birth
4

Score of Problem solving

6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold

Time frame
Up to 24 months after birth

Other outcomes

Sponsors and contacts

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