NCT04099784

Brief Summary

In order to give strong recommendation on the efficacy and safety of fresh versus frozen embryo transfer, we conduct this study in order to investigate the physical and mental development of children from fresh versus frozen embryo transfer. Based on our Freeze-only study (Vuong et al., 2018), the women without polycystic ovary syndrome undergoing the first or second IVF were randomly assigned to receive either fresh or frozen embryos on day 3 after oocyte retrieval, which leads to the similarity in characteristics of these two groups. Hence, the result from analysing these offsprings would be preciously valuable.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

March 3, 2020

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

September 14, 2019

Last Update Submit

March 2, 2020

Conditions

InfertilityIVF

Keywords

Fresh transfer, freeze-only, ASQ-3, health of children

Outcome Measures

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.

    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 (13)

  • Gestational age at delivery

    At birth

  • Mode of delivery

    At birth

  • Birth weight

    At birth

  • +10 more other outcomes

Study Arms (2)

Freeze-only

Children born from freeze-only group and frozen embryo transfer

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

Fresh

Children born from fresh embryo transfer

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.

Freeze-onlyFresh
Physical development and General HealthOTHER

Physical development and General health examination

Freeze-onlyFresh
Developmental Red flagsOTHER

Developmental Red flags Questionnaires

Freeze-onlyFresh

Eligibility Criteria

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

Live babies born following the frozen embryo transfer and fresh embryo transfer from our Freeze-only study (NCT02471573)

You may qualify if:

  • Live babies born from the first transfer of both freeze-only and fresh embryo transfer group from our Freeze-only study.
  • Parents agree to participate in the study.

You may not qualify if:

  • Babies died after perinatal period.

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 (7)

  • Chen ZJ, Shi Y, Sun Y, Zhang B, Liang X, Cao Y, Yang J, Liu J, Wei D, Weng N, Tian L, Hao C, Yang D, Zhou F, Shi J, Xu Y, Li J, Yan J, Qin Y, Zhao H, Zhang H, Legro RS. Fresh versus Frozen Embryos for Infertility in the Polycystic Ovary Syndrome. N Engl J Med. 2016 Aug 11;375(6):523-33. doi: 10.1056/NEJMoa1513873.

    PMID: 27509101BACKGROUND

  • Shi Y, Sun Y, Hao C, Zhang H, Wei D, Zhang Y, Zhu Y, Deng X, Qi X, Li H, Ma X, Ren H, Wang Y, Zhang D, Wang B, Liu F, Wu Q, Wang Z, Bai H, Li Y, Zhou Y, Sun M, Liu H, Li J, Zhang L, Chen X, Zhang S, Sun X, Legro RS, Chen ZJ. Transfer of Fresh versus Frozen Embryos in Ovulatory Women. N Engl J Med. 2018 Jan 11;378(2):126-136. doi: 10.1056/NEJMoa1705334.

    PMID: 29320646BACKGROUND

  • Vuong LN, Dang VQ, Ho TM, Huynh BG, Ha DT, Pham TD, Nguyen LK, Norman RJ, Mol BW. IVF Transfer of Fresh or Frozen Embryos in Women without Polycystic Ovaries. N Engl J Med. 2018 Jan 11;378(2):137-147. doi: 10.1056/NEJMoa1703768.

    PMID: 29320655BACKGROUND

  • Wei D, Liu JY, Sun Y, Shi Y, Zhang B, Liu JQ, Tan J, Liang X, Cao Y, Wang Z, Qin Y, Zhao H, Zhou Y, Ren H, Hao G, Ling X, Zhao J, Zhang Y, Qi X, Zhang L, Deng X, Chen X, Zhu Y, Wang X, Tian LF, Lv Q, Ma X, Zhang H, Legro RS, Chen ZJ. Frozen versus fresh single blastocyst transfer in ovulatory women: a multicentre, randomised controlled trial. Lancet. 2019 Mar 30;393(10178):1310-1318. doi: 10.1016/S0140-6736(18)32843-5. Epub 2019 Feb 28.

    PMID: 30827784BACKGROUND

  • Pelkonen S, Koivunen R, Gissler M, Nuojua-Huttunen S, Suikkari AM, Hyden-Granskog C, Martikainen H, Tiitinen A, Hartikainen AL. Perinatal outcome of children born after frozen and fresh embryo transfer: the Finnish cohort study 1995-2006. Hum Reprod. 2010 Apr;25(4):914-23. doi: 10.1093/humrep/dep477. Epub 2010 Feb 2.

    PMID: 20124395BACKGROUND

  • Spangmose AL, Malchau SS, Henningsen AA, Forman JL, Rasmussen S, Loft A, Schmidt L, Pinborg A. Academic performance in adolescents aged 15-16 years born after frozen embryo transfer compared with fresh embryo transfer: a nationwide registry-based cohort study. BJOG. 2019 Jan;126(2):261-269. doi: 10.1111/1471-0528.15484. Epub 2018 Oct 24.

    PMID: 30276983BACKGROUND

  • Vuong LN, Ly TT, Nguyen NA, Nguyen LMT, Le XTH, Le TK, Le KTQ, Le TV, Nguyen MHN, Dang VQ, Norman RJ, Mol BW, Ho TM. Development of children born from freeze-only versus fresh embryo transfer: follow-up of a randomized controlled trial. Fertil Steril. 2020 Sep;114(3):558-566. doi: 10.1016/j.fertnstert.2020.04.041. Epub 2020 Jun 16.

    PMID: 32560970DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Health Status

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

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
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2019

First Posted

September 23, 2019

Study Start

September 1, 2019

Primary Completion

November 15, 2019

Study Completion

November 20, 2019

Last Updated

March 3, 2020

Record last verified: 2019-11

Locations

VN(1)