NCT04048486

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 7, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

August 2, 2019

Last Update Submit

October 8, 2020

Conditions

IVMIVF

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 66 months after birth

Secondary Outcomes (12)

  • Score of Communication

    Up to 66 months after birth

  • Score of Gross motor

    Up to 66 months after birth

  • Score of Fine motor

    Up to 66 months after birth

  • Score of Problem solving

    Up to 66 months after birth

  • Score of Personal-Social

    Up to 66 months after birth

  • +7 more secondary outcomes

Other Outcomes (15)

  • Gestational age at delivery

    At birth

  • Mode of delivery

    At birth

  • Birth weight

    At birth

  • +12 more other outcomes

Study Arms (3)

CAPA-IVM

Live babies born from CAPA-IVM

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

IVF/ICSI

Live babies born from IVF/ICSI

Natural conception

Live babies born from natural conception

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

Interventions

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.

CAPA-IVMNatural conception
Physical development and General HealthOTHER

Physical development and General health examination

CAPA-IVMNatural conception
Developmental Red flagsOTHER

Developmental Red flags Questionnaires

CAPA-IVMNatural conception

Eligibility Criteria

Age1 Month - 66 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Live babies born from CAPA-IVM, IVF or natural conception

You may qualify if:

  • Live babies born from CAPA-IVM
  • Live babies born from IVF
  • Live babies born from natural conception
  • Parents agree to participate

You may not qualify if:

  • Babies born from oocyte donation cycles
  • Babies born from sperm donation cycles
  • Babies born from PGT cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

Location

Related Publications (10)

  • 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.

    PMID: 24659912BACKGROUND

  • Helmerhorst 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.

    PMID: 14742347BACKGROUND

  • Pinborg 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.

    PMID: 23154145BACKGROUND

  • McDonald 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.

    PMID: 19577836BACKGROUND

  • Pandey 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.

    PMID: 22611174BACKGROUND

  • Hart 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.

    PMID: 23449642BACKGROUND

  • Hart 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.

    PMID: 23449643BACKGROUND

  • Kalra 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.

    PMID: 21411083BACKGROUND

  • Oliver 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.

    PMID: 22112648BACKGROUND

  • Barker 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.

    PMID: 17444880BACKGROUND

Related Links

MeSH Terms

Interventions

Health Status

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Lan N Vuong, MD, PhD

    Mỹ Đức Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 7, 2019

Study Start

August 7, 2019

Primary Completion

September 30, 2019

Study Completion

December 15, 2019

Last Updated

October 12, 2020

Record last verified: 2020-10

Locations

VN(1)