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

Last updated: December 24, 2024
Sponsor: Mỹ Đức Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Physical development and General Health

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

Developmental Red flags

Clinical Study ID

NCT05502770
09/22/DD-BVMD
  • Ages 6-18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All live IVF/ICSI babies born from frozen embryo transfer following the naturalcycle, modified natural cycle, and artificial cycle from MONART study

  • Parents agree to participate in the study.

Exclusion

Exclusion Criteria:

  • Babies died under or at 24 months

Study Design

Total Participants: 700
Treatment Group(s): 3
Primary Treatment: Physical development and General Health
Phase:
Study Start date:
August 12, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • My Duc Hospital

    Ho Chi Minh City, 70000
    Vietnam

    Active - Recruiting

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