MONARTBABIES: Development of IVF/ICSI Children Born From Different Endometrial Preparation Protocols
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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 18 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Natural cycle children Children born from frozen embryo transfer with natural cycle protocol |
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
|
| Modified natural cycle children Children born from frozen embryo transfer with modified natural cycle protocol |
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
|
| Artificial cycle children Children born from frozen embryo transfer with artificial cycle protocol |
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
|
Outcome Measures
Primary Outcome Measures
- The average total ASQ-3 score [Up to 18 months after birth]
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.
Secondary Outcome Measures
- Score of Communication [Up to 18 months after birth]
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
- Score of Gross motor [Up to 18 months after birth]
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
- Score of Fine motor [Up to 18 months after birth]
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
- Score of Problem solving [Up to 18 months after birth]
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
- Score of Personal-Social [Up to 18 months after birth]
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
- The rate of children who have at least one red flag sign [From 6 months to 18 months after birth]
He or she has at least one red flag sign by age. For children at 6 months: he or she Lack of turning toward voices. Does not pass object from one hand to another. No smiling, laughing, or expression. For children at 12 months: he or she Child does not respond to name. Does not understand "no". Does not stand or bear weight on legs when supported. Indifferent or resistant attachment to caregiver. Does not look where caregiver points. For children at 18 months: he or she has Not using at least 6 words. Inability to walk independently. Absence of proto-imperative pointing (point to show interest) or showing gesture.
Eligibility Criteria
Criteria
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 18 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | My Duc Hospital | Ho Chi Minh City | Vietnam | 70000 |
Sponsors and Collaborators
- Mỹ Đức Hospital
Investigators
- Study Chair: Lan N Vuong, University of Medicine and Pharmacy at Ho Chi Minh City
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09/22/DD-BVMD