Health of IVF Versus IVM Children (FM-BABIES)

NCT04296357 | Completed

• 1 other identifier: CS/BVMĐ/20/05
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators conduct a follow up of our randomized controlled trial (RCT) to investigate the development of children born from In-vitro fertilization (IVF) and In-vitro maturation (IVM), in order to give strong evidence about the safety of IVM in women with high antral follicle count or especially polycystic ovary syndrome (PCOS).

Conditions

Infertility; IVF; IVM

Keywords

IVF; IVM; 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 24 months after birth

Secondary Outcomes (12)

• Score of Communication

  Up to 24 months after birth

• Score of Gross motor

  Up to 24 months after birth

• Score of Fine motor

  Up to 24 months after birth

• Score of Problem solving

  Up to 24 months after birth

• Score of Personal-Social

  Up to 24 months after birth

Other Outcomes (13)

• Gestational age at delivery

  At birth

• Mode of delivery

  At birth

• Birth weight

  At birth

Study Arms (2)

IVF children

Children born from in-vitro fertilization

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

IVM children

Children born from in-vitro maturation

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

Interventions

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

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.

IVF children; IVM children

Physical development and General Health OTHER

Physical development and General health examination

IVF children; IVM children

Developmental Red flags DIAGNOSTIC_TEST

Developmental Red flags Questionnaires

IVF children; IVM children

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Live babies born following the IVF and IVM from our FM study (NCT03405701)

You may qualify if:

• All live babies born following the In-vitro Maturation and In-vitro fertilization from our FM study.
• Parents agree to participate in the study.

You may not qualify if:

• Babies died under or at 24 months

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

Mỹ Đức Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (11)

• Vuong LN, Ho VNA, Ho TM, Dang VQ, Phung TH, Giang NH, Le AH, Pham TD, Wang R, Norman RJ, Smitz J, Gilchrist RB, Mol BW. Effectiveness and safety of in vitro maturation of oocytes versus in vitro fertilisation in women with high antral follicle count: study protocol for a randomised controlled trial. BMJ Open. 2018 Dec 9;8(12):e023413. doi: 10.1136/bmjopen-2018-023413.

  PMID: 30530584 BACKGROUND

• Cha KY, Koo JJ, Ko JJ, Choi DH, Han SY, Yoon TK. Pregnancy after in vitro fertilization of human follicular oocytes collected from nonstimulated cycles, their culture in vitro and their transfer in a donor oocyte program. Fertil Steril. 1991 Jan;55(1):109-13. doi: 10.1016/s0015-0282(16)54068-0.

  PMID: 1986950 RESULT

• Das M, Son WY, Buckett W, Tulandi T, Holzer H. In-vitro maturation versus IVF with GnRH antagonist for women with polycystic ovary syndrome: treatment outcome and rates of ovarian hyperstimulation syndrome. Reprod Biomed Online. 2014 Nov;29(5):545-51. doi: 10.1016/j.rbmo.2014.07.019. Epub 2014 Aug 12.

  PMID: 25262236 RESULT

• Gremeau AS, Andreadis N, Fatum M, Craig J, Turner K, McVeigh E, Child T. In vitro maturation or in vitro fertilization for women with polycystic ovaries? A case-control study of 194 treatment cycles. Fertil Steril. 2012 Aug;98(2):355-60. doi: 10.1016/j.fertnstert.2012.04.046. Epub 2012 May 31.

  PMID: 22658347 RESULT

• Ho VNA, Braam SC, Pham TD, Mol BW, Vuong LN. The effectiveness and safety of in vitro maturation of oocytes versus in vitro fertilization in women with a high antral follicle count. Hum Reprod. 2019 Jun 4;34(6):1055-1064. doi: 10.1093/humrep/dez060.

  PMID: 31111879 RESULT

• Mostinckx L, Segers I, Belva F, Buyl R, Santos-Ribeiro S, Blockeel C, Smitz J, Anckaert E, Tournaye H, De Vos M. Obstetric and neonatal outcome of ART in patients with polycystic ovary syndrome: IVM of oocytes versus controlled ovarian stimulation. Hum Reprod. 2019 Aug 1;34(8):1595-1607. doi: 10.1093/humrep/dez086.

  PMID: 31347678 RESULT

• Roesner S, von Wolff M, Elsaesser M, Roesner K, Reuner G, Pietz J, Bruckner T, Strowitzki T. Two-year development of children conceived by IVM: a prospective controlled single-blinded study. Hum Reprod. 2017 Jun 1;32(6):1341-1350. doi: 10.1093/humrep/dex068.

  PMID: 28387798 RESULT

• Sauerbrun-Cutler MT, Vega M, Keltz M, McGovern PG. In vitro maturation and its role in clinical assisted reproductive technology. Obstet Gynecol Surv. 2015 Jan;70(1):45-57. doi: 10.1097/OGX.0000000000000150.

  PMID: 25616347 RESULT

• Shu-Chi M, Jiann-Loung H, Yu-Hung L, Tseng-Chen S, Ming-I L, Tsu-Fuh Y. Growth and development of children conceived by in-vitro maturation of human oocytes. Early Hum Dev. 2006 Oct;82(10):677-82. doi: 10.1016/j.earlhumdev.2006.01.012. Epub 2006 May 11.

  PMID: 16690233 RESULT

• Yu EJ, Yoon TK, Lee WS, Park EA, Heo JY, Ko YK, Kim J. Obstetrical, neonatal, and long-term outcomes of children conceived from in vitro matured oocytes. Fertil Steril. 2019 Oct;112(4):691-699. doi: 10.1016/j.fertnstert.2019.05.034. Epub 2019 Jul 29.

  PMID: 31371040 RESULT

• Vuong LN, Nguyen MHN, Nguyen NA, Ly TT, Tran VTT, Nguyen NT, Hoang HLT, Le XTH, Pham TD, Smitz JEJ, Mol BW, Norman RJ, Ho TM. Development of children born from IVM versus IVF: 2-year follow-up of a randomized controlled trial. Hum Reprod. 2022 Jul 30;37(8):1871-1879. doi: 10.1093/humrep/deac115.

  PMID: 35595193 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Health Status

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment 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: March 3, 2020
• First Posted: March 5, 2020
• Study Start: March 1, 2020
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

VN (1)