IVMNCT04048486
Children Born From IVM-CAPA vs IVF or Natural Conception
An observational study of IVM and IVF, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
CAPA-IVM is a new promising IVM technique involving the use of a new compound to facilitate the oocyte and embryo competence. CAPA-IVM preserved the maintenance of trans-zonal projections and significantly improved maturation rate and blastocyst yield. Read more about this study
- Who is it for?
- Ages 1 month to 66 months
- What is being tested?
- Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Physical development and General Health and Developmental Red flags
- How many people
- 66 participants
- Where
- 1 siteVietnam
- Study dates
- 7 Aug 2019to 15 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 66 months
- All sexes
- Child
Study population: Live babies born from CAPA-IVM, IVF or natural conception
Who may be able to join
- Live babies born from CAPA-IVM
- Live babies born from IVF
- Live babies born from natural conception
- Parents agree to participate
Who cannot join
- Babies born from oocyte donation cycles
- Babies born from sperm donation cycles
- Babies born from PGT cycles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up of Children Born From CAPA-IVM IVF or Natural Conception: a Prospective Cohort Study
CAPA-IVM is a new promising IVM technique involving the use of a new compound to facilitate the oocyte and embryo competence. CAPA-IVM preserved the maintenance of trans-zonal projections and significantly improved maturation rate and blastocyst yield. NGS analysis of 20 good quality CAPA-IVM blastocysts did not reveal increased aneuploidy compared to age-matched routine ICSI patients. The first CAPA-IVM baby was born in 2017 at My Duc Hospital, Vietnam and up to now, there are 33 babies born from this technique. There is no study to investigate the development of babies born from CAPA-IVM.
Read the detailed description
Assisted reproductive technologies (ART), such as in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI) and in vitro maturation (IVM), are widely used to solve human infertility, and have provided great benefits for millions of couples who have struggled with infertility disorders. The use of ART has been growing persistently and more than 8 million babies worldwide have been born via ART since the first IVF conceived child was born in 1978 (ESHRE monitoring).
During the last two decades, many studies have shown that children born following assisted reproductive techniques (ART) have an increased risk of adverse obstetric, perinatal and short-term follow-up outcomes when compared to naturally conceived (NC) infants (Jackson RA 2004, Helmerhorst et al., 2004; Pinborg et al., 2013; Adams et al., 2015). The etiologies of this association are mainly related to higher proportion of multiple pregnancies due to double embryo transfer option and greater rate of unfavorable comorbidities of infertile women (older age, high BMI, diabetes…). But with the trend toward single embryo transfer in current IVF practice, there are existing evidences supporting that the perinatal risks of singleton gestations following IVF treatment are still higher than those that result from a spontaneous conception (McDonald et al., 2009; Pandey et al., 2012).
Long-term development of children born by ART is also a concerned issue. It is evident that children born as a result of IVF treatment have an excess rate of congenital abnormalities, higher risk of developing metabolic, cardiovascular disorders and subclinical hyperthyroidism in later life (Roger Hart and Robert J. Norman, 2013, part I). Regarding mental health and development outcomes, cerebral palsy and slight neurodevelopmental delay are potential long-term associations with ART (Roger Hart and Robert J. Norman, 2013, part II). However, these adverse outcomes can be explained by obstetric factors (higher rate of prematurity and intrauterine growth restriction) rather than IVF. This leads to the concern about research biases in studies of long-term development of children born by ART where multiple gestations, prematurity, neonatal hospitalization and growth restriction were not well-controlled. Another concern about long-term follow-up studies of IVF children is the limitation of literatures and high-quality clinical trials that investigate the general health outcomes of children born by ART. The majority of valuable data only exist on the short-term outcome of infants born as a result of IVF treatment (Kalra and Barnhart, 2011) even though it is possible that some suspected disorders might only be identifiable beyond the first year of life (Oliver et al., 2012).
When studying about the long-term development of children following ART, a very important factor need to be considered is the medium of culture. There have been existing theories that proposed the mechanism of how epigenetic environment can up or down-regulate a set of genes which then results in the changes in embryonic growth or even the long-term development of children in later stage of life. Different ART methods may cause possible changes in DNA methylation patterns which in turn affect development of the placenta and fetus. This is the "developmental origins of health and disease hypothesis" (DOHaD) explaning why exposure to an adverse environment (possibly the culture medium) may result in unfavorable development and illnesses profiles in the ART offspring (Barker, 2007).
CAPA-IVM is a new promising IVM technique involving the use of a new compound to facilitate the oocyte and embryo competence. CAPA-IVM preserved the maintenance of trans-zonal projections and significantly improved maturation rate and blastocyst yield. NGS analysis of 20 good quality CAPA-IVM blastocysts did not reveal increased aneuploidy compared to age matched routine ICSI patients. The first CAPA-IVM baby was born in 2017 at My Duc Hospital, Vietnam and up to now, there are 33 babies born from this technique. There is no study to investigate the development of babies born from CAPA-IVM.
The investigators therefore conduct this study to investigate the physical and mental development of babies born from CAPA-IVM, IVF or natural conception.
- Being tested
- Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Physical development and General Health, Developmental Red flags
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3Other
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 HealthOther
Physical development and General health examination
Developmental Red flagsOther
Developmental Red flags Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| CAPA-IVM | Live babies born from CAPA-IVM Receives: Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Other: Physical development and General Health; Other: Developmental Red flags | |
| IVF/ICSI | Live babies born from IVF/ICSI | |
| Natural conception | Live babies born from natural conception Receives: Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Other: Physical development and General Health; Other: Developmental Red flags |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average total ASQ-3 score
- ASQ-3 (Ages and Stages Questionares®) has 5 aspects: Communication, Gross motor, Fine motor, Problem solving and Personal-Social
- Each aspesct has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0.
- ASQ-3 average = average score of 5 aspects.
Measured: Up to 66 months after birth
Secondary outcomes (12)
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
Measured: Up to 66 months after birth
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
Measured: Up to 66 months after birth
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
Measured: Up to 66 months after birth
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
Measured: Up to 66 months after birth
Score of Personal-Social
- 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
Measured: Up to 66 months after birth
The presence of red flag signs by age
- For children less than 4 months
- Rolling prior to 3 months
- Persistent fisting at 3 months
- Failure to alert to environmental stimuli
- For children from 4 to 6 months
- Poor head control
- Failure to reach for objects by 5 months
- Absent smile
- For children from 6 to 12 months
- Absent babbling by 6 months
- W-sitting at 7 months
- Inability to localize sound by 10 months
- Persistent mouthing of objects at 12 months
- Lack of consonant production by 15 months
- For children from 12 to 24 months
- Lack of imitation by 16 months
- Lack of protodeclarative pointing by 18 months
- Hand dominance prior to 18 months
- Inability to walk up and down stairs at 24 months
- Advanced non-communicative speech (meaningless communication repertoires)
- Delayed Language Development milestone (50 single words at 24 months)
Measured: Up to 24 months after birth
Duration of breast-feeding
Duration of breast-feeding
Measured: Up to 24 months after birth
Infant age at which weaning starts
Infant age at which weaning starts
Measured: Up to 24 months after birth
Diseases that lead to hospital admission
Diseases that lead to hospital admission
Measured: Up to 24 months after birth
Number of hospital admission
Number of hospital admission
Measured: Up to 24 months after birth
Weight
Weight at 3, 6, 12, 18, 24 months and on the examination date
Measured: At 3, 6, 12, 18, 24 months and on the examination date
Height
Height at 3, 6, 12, 18, 24 months and on the examination date
Measured: At 3, 6, 12, 18, 24 months and on the examination date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start7 Aug 2019
- Primary completion30 Sep 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for IVMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan N Vuong, MD, PhD, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048486
- Sponsor's protocol ID
- CS/BVMĐ/19/07
- Status last verified
- Oct 2020
- First submitted
- 2 Aug 2019
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stephens SM, Arnett DM, Meacham RB. The use of in vitro fertilization in the management of male infertility: what the urologist needs to know. Rev Urol. 2013;15(4):154-60.
PubMed 24659912Helmerhorst FM, Perquin DA, Donker D, Keirse MJ. Perinatal outcome of singletons and twins after assisted conception: a systematic review of controlled studies. BMJ. 2004 Jan 31;328(7434):261. doi: 10.1136/bmj.37957.560278.EE. Epub 2004 Jan 23.
PubMed 14742347Pinborg A, Wennerholm UB, Romundstad LB, Loft A, Aittomaki K, Soderstrom-Anttila V, Nygren KG, Hazekamp J, Bergh C. Why do singletons conceived after assisted reproduction technology have adverse perinatal outcome? Systematic review and meta-analysis. Hum Reprod Update. 2013 Mar-Apr;19(2):87-104. doi: 10.1093/humupd/dms044. Epub 2012 Nov 14.
PubMed 23154145McDonald SD, Han Z, Mulla S, Murphy KE, Beyene J, Ohlsson A; Knowledge Synthesis Group. Preterm birth and low birth weight among in vitro fertilization singletons: a systematic review and meta-analyses. Eur J Obstet Gynecol Reprod Biol. 2009 Oct;146(2):138-48. doi: 10.1016/j.ejogrb.2009.05.035. Epub 2009 Jul 4.
PubMed 19577836Pandey S, Shetty A, Hamilton M, Bhattacharya S, Maheshwari A. Obstetric and perinatal outcomes in singleton pregnancies resulting from IVF/ICSI: a systematic review and meta-analysis. Hum Reprod Update. 2012 Sep-Oct;18(5):485-503. doi: 10.1093/humupd/dms018. Epub 2012 May 19.
PubMed 22611174Hart R, Norman RJ. The longer-term health outcomes for children born as a result of IVF treatment: Part I--General health outcomes. Hum Reprod Update. 2013 May-Jun;19(3):232-43. doi: 10.1093/humupd/dms062. Epub 2013 Feb 28.
PubMed 23449642Hart R, Norman RJ. The longer-term health outcomes for children born as a result of IVF treatment. Part II--Mental health and development outcomes. Hum Reprod Update. 2013 May-Jun;19(3):244-50. doi: 10.1093/humupd/dmt002. Epub 2013 Feb 28.
PubMed 23449643Kalra SK, Barnhart KT. In vitro fertilization and adverse childhood outcomes: what we know, where we are going, and how we will get there. A glimpse into what lies behind and beckons ahead. Fertil Steril. 2011 May;95(6):1887-9. doi: 10.1016/j.fertnstert.2011.02.044. Epub 2011 Mar 16.
PubMed 21411083Oliver VF, Miles HL, Cutfield WS, Hofman PL, Ludgate JL, Morison IM. Defects in imprinting and genome-wide DNA methylation are not common in the in vitro fertilization population. Fertil Steril. 2012 Jan;97(1):147-53.e7. doi: 10.1016/j.fertnstert.2011.10.027. Epub 2011 Nov 23.
PubMed 22112648Barker DJ. The origins of the developmental origins theory. J Intern Med. 2007 May;261(5):412-7. doi: 10.1111/j.1365-2796.2007.01809.x.
PubMed 17444880
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Children Born From CAPA-IVM IVF or Natural Conception: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04048486
- Acronym / sponsor ID
- CS/BVMĐ/19/07
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CAPA-IVM is a new promising IVM technique involving the use of a new compound to facilitate the oocyte and embryo competence. CAPA-IVM preserved the maintenance of trans-zonal projections and significantly improved maturation rate and blastocyst yield. NGS analysis of 20 good quality CAPA-IVM blastocysts did not reveal increased aneuploidy compared to age-matched routine ICSI patients. The first CAPA-IVM baby was born in 2017 at My Duc Hospital, Vietnam and up to now, there are 33 babies born from this technique. There is no study to investigate the development of babies born from CAPA-IVM.
Detailed description
Assisted reproductive technologies (ART), such as in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI) and in vitro maturation (IVM), are widely used to solve human infertility, and have provided great benefits for millions of couples who have struggled with infertility disorders. The use of ART has been growing persistently and more than 8 million babies worldwide have been born via ART since the first IVF conceived child was born in 1978 (ESHRE monitoring).
During the last two decades, many studies have shown that children born following assisted reproductive techniques (ART) have an increased risk of adverse obstetric, perinatal and short-term follow-up outcomes when compared to naturally conceived (NC) infants (Jackson RA 2004, Helmerhorst et al., 2004; Pinborg et al., 2013; Adams et al., 2015). The etiologies of this association are mainly related to higher proportion of multiple pregnancies due to double embryo transfer option and greater rate of unfavorable comorbidities of infertile women (older age, high BMI, diabetes…). But with the trend toward single embryo transfer in current IVF practice, there are existing evidences supporting that the perinatal risks of singleton gestations following IVF treatment are still higher than those that result from a spontaneous conception (McDonald et al., 2009; Pandey et al., 2012).
Long-term development of children born by ART is also a concerned issue. It is evident that children born as a result of IVF treatment have an excess rate of congenital abnormalities, higher risk of developing metabolic, cardiovascular disorders and subclinical hyperthyroidism in later life (Roger Hart and Robert J. Norman, 2013, part I). Regarding mental health and development outcomes, cerebral palsy and slight neurodevelopmental delay are potential long-term associations with ART (Roger Hart and Robert J. Norman, 2013, part II). However, these adverse outcomes can be explained by obstetric factors (higher rate of prematurity and intrauterine growth restriction) rather than IVF. This leads to the concern about research biases in studies of long-term development of children born by ART where multiple gestations, prematurity, neonatal hospitalization and growth restriction were not well-controlled. Another concern about long-term follow-up studies of IVF children is the limitation of literatures and high-quality clinical trials that investigate the general health outcomes of children born by ART. The majority of valuable data only exist on the short-term outcome of infants born as a result of IVF treatment (Kalra and Barnhart, 2011) even though it is possible that some suspected disorders might only be identifiable beyond the first year of life (Oliver et al., 2012).
When studying about the long-term development of children following ART, a very important factor need to be considered is the medium of culture. There have been existing theories that proposed the mechanism of how epigenetic environment can up or down-regulate a set of genes which then results in the changes in embryonic growth or even the long-term development of children in later stage of life. Different ART methods may cause possible changes in DNA methylation patterns which in turn affect development of the placenta and fetus. This is the "developmental origins of health and disease hypothesis" (DOHaD) explaning why exposure to an adverse environment (possibly the culture medium) may result in unfavorable development and illnesses profiles in the ART offspring (Barker, 2007).
CAPA-IVM is a new promising IVM technique involving the use of a new compound to facilitate the oocyte and embryo competence. CAPA-IVM preserved the maintenance of trans-zonal projections and significantly improved maturation rate and blastocyst yield. NGS analysis of 20 good quality CAPA-IVM blastocysts did not reveal increased aneuploidy compared to age matched routine ICSI patients. The first CAPA-IVM baby was born in 2017 at My Duc Hospital, Vietnam and up to now, there are 33 babies born from this technique. There is no study to investigate the development of babies born from CAPA-IVM.
The investigators therefore conduct this study to investigate the physical and mental development of babies born from CAPA-IVM, IVF or natural conception.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAPA-IVM | – | Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Other: Physical development and General Health, Other: Developmental Red flagsLive babies born from CAPA-IVM |
| IVF/ICSI | – | –Live babies born from IVF/ICSI |
| Natural conception | – | Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Other: Physical development and General Health, Other: Developmental Red flagsLive babies born from natural conception |
Who may qualify
- Ages
- 1 month to 66 months
- Sex
- All
- Age groups
- Child
- Study population
- Live babies born from CAPA-IVM, IVF or natural conception
Key inclusion criteria (4 listed)
- Live babies born from CAPA-IVM
- Live babies born from IVF
- Live babies born from natural conception
- Parents agree to participate
Key exclusion criteria (3 listed)
- Babies born from oocyte donation cycles
- Babies born from sperm donation cycles
- Babies born from PGT cycles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3Ages \& 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 | CAPA-IVM, Natural conception |
| Physical development and General HealthPhysical development and General health examination | Other | CAPA-IVM, Natural conception |
| Developmental Red flagsDevelopmental Red flags Questionnaires | Other | CAPA-IVM, Natural conception |
Primary outcome
The average total ASQ-3 score
Time frame: Up to 66 months after birth
* ASQ-3 (Ages and Stages Questionares®) has 5 aspects: Communication, Gross motor, Fine motor, Problem solving and Personal-Social * Each aspesct has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. * ASQ-3 average = average score of 5 aspects.
12 secondary outcomes
Score of Communication
Time frame: Up to 66 months after birth
Score of Gross motor
Time frame: Up to 66 months after birth
Score of Fine motor
Time frame: Up to 66 months after birth
Score of Problem solving
Time frame: Up to 66 months after birth
Score of Personal-Social
Time frame: Up to 66 months after birth
The presence of red flag signs by age
Time frame: Up to 24 months after birth
Duration of breast-feeding
Time frame: Up to 24 months after birth
Infant age at which weaning starts
Time frame: Up to 24 months after birth
Diseases that lead to hospital admission
Time frame: Up to 24 months after birth
Number of hospital admission
Time frame: Up to 24 months after birth
Weight
Time frame: At 3, 6, 12, 18, 24 months and on the examination date
Height
Time frame: At 3, 6, 12, 18, 24 months and on the examination date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Background: PubMed 24659912Stephens SM, Arnett DM, Meacham RB. The use of in vitro fertilization in the management of male infertility: what the urologist needs to know. Rev Urol. 2013;15(4):154-60.
- Background: PubMed 14742347Helmerhorst FM, Perquin DA, Donker D, Keirse MJ. Perinatal outcome of singletons and twins after assisted conception: a systematic review of controlled studies. BMJ. 2004 Jan 31;328(7434):261. doi: 10.1136/bmj.37957.560278.EE. Epub 2004 Jan 23.
- Background: PubMed 23154145Pinborg A, Wennerholm UB, Romundstad LB, Loft A, Aittomaki K, Soderstrom-Anttila V, Nygren KG, Hazekamp J, Bergh C. Why do singletons conceived after assisted reproduction technology have adverse perinatal outcome? Systematic review and meta-analysis. Hum Reprod Update. 2013 Mar-Apr;19(2):87-104. doi: 10.1093/humupd/dms044. Epub 2012 Nov 14.
- Background: PubMed 19577836McDonald SD, Han Z, Mulla S, Murphy KE, Beyene J, Ohlsson A; Knowledge Synthesis Group. Preterm birth and low birth weight among in vitro fertilization singletons: a systematic review and meta-analyses. Eur J Obstet Gynecol Reprod Biol. 2009 Oct;146(2):138-48. doi: 10.1016/j.ejogrb.2009.05.035. Epub 2009 Jul 4.
- Background: PubMed 22611174Pandey S, Shetty A, Hamilton M, Bhattacharya S, Maheshwari A. Obstetric and perinatal outcomes in singleton pregnancies resulting from IVF/ICSI: a systematic review and meta-analysis. Hum Reprod Update. 2012 Sep-Oct;18(5):485-503. doi: 10.1093/humupd/dms018. Epub 2012 May 19.
- Background: PubMed 23449642Hart R, Norman RJ. The longer-term health outcomes for children born as a result of IVF treatment: Part I--General health outcomes. Hum Reprod Update. 2013 May-Jun;19(3):232-43. doi: 10.1093/humupd/dms062. Epub 2013 Feb 28.
- Background: PubMed 23449643Hart R, Norman RJ. The longer-term health outcomes for children born as a result of IVF treatment. Part II--Mental health and development outcomes. Hum Reprod Update. 2013 May-Jun;19(3):244-50. doi: 10.1093/humupd/dmt002. Epub 2013 Feb 28.
- Background: PubMed 21411083Kalra SK, Barnhart KT. In vitro fertilization and adverse childhood outcomes: what we know, where we are going, and how we will get there. A glimpse into what lies behind and beckons ahead. Fertil Steril. 2011 May;95(6):1887-9. doi: 10.1016/j.fertnstert.2011.02.044. Epub 2011 Mar 16.
- Background: PubMed 22112648Oliver VF, Miles HL, Cutfield WS, Hofman PL, Ludgate JL, Morison IM. Defects in imprinting and genome-wide DNA methylation are not common in the in vitro fertilization population. Fertil Steril. 2012 Jan;97(1):147-53.e7. doi: 10.1016/j.fertnstert.2011.10.027. Epub 2011 Nov 23.
- Background: PubMed 17444880Barker DJ. The origins of the developmental origins theory. J Intern Med. 2007 May;261(5):412-7. doi: 10.1111/j.1365-2796.2007.01809.x.
- De GeyterLink provided by the sponsor.
- Adams: A meta-analysis of neonatal health outcomesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan N Vuong, MD, PhD principal investigator
Mỹ Đức Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVM and IVF, run by Mỹ Đức Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average total ASQ-3 score (time frame: Up to 66 months after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048486, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020; AzTrials last refreshed its copy on 31 Oct 2026.