Child Follow-up in Women Treated With Conventional IVF or ICSI

NCT04866524 | Completed

• 1 other identifier: 04/2021/MĐ-HĐĐĐ
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the physical, mental and motor development of babies born from pregnancy using ICSI technique and and conventional IVF in non-male factor infertile couples. Based on our previous RCT (NCT03428919), the non-male factor couples were randomly assigned to IVF or ICSI, which leads to the similarity in characteristics of these two groups. Hence, the result of analyzing these offsprings would be preciously valuable.

Conditions

Conventional IVF, ICSI

Outcome Measures

Primary Outcomes (1)

• The number of patients having abnormal ASQ-3 scores in each aspect

  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. Abnormal ASQ-3 score in an aspect = ASQ-3 score of 2 standard deviations below the mean of the aspect.

  Up to 66 months after birth

Secondary Outcomes (11)

• 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

Other Outcomes (1)

• The rate of long-term illness and chronic conditions

  Up to 66 months after birth

Study Arms (2)

ICSI technique

In ICSI group, insemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. OCCs will be stripped by using hyaluronidase. Only matured oocytes will be inseminated.

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

Conventional IVF

In conventional IVF group, insemination will be performed by conventional IVF. Two hours after retrieval, collected OCCs will be inseminated for another 2 hours, at a concentration of 100,000 motile sperm/ml. Inseminated OCCs will be cultured overnight in culture medium.

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

Interventions

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

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.

Conventional IVF; ICSI technique

Physical development and General Health OTHER

Physical development and General health examination

Conventional IVF; ICSI technique

Developmental Red flags OTHER

Developmental Red flags Questionnaires

Conventional IVF; ICSI technique

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Live babies born through intracytoplasmic sperm injection (ICSI) versus conventional in vitro fertilization (IVF) in couples with non-male factor infertility (NCT03428919)

You may qualify if:

• Live babies born from ICSI Versus Conventional IVF in Non-male Factor Couples (NCT03428919)
• Parents agree to participate in the study.

You may not qualify if:

• Babies died after the perinatal period.

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

Location

Related Publications (1)

• Nguyen NA, Nguyen NT, Tran VTT, Vo TTM, Uong TS, Nguyen HT, Nguyen NT, Nguyen DL, Pham TD, Nguyen DTN, Ho TM, Vuong LN. Developmental outcomes of children born through ICSI versus conventional IVF (cIVF) in couples with non-male factor infertility. Hum Reprod. 2024 Jun 5:deae120. doi: 10.1093/humrep/deae120. Online ahead of print.

  PMID: 38840410 DERIVED

MeSH Terms

Interventions

Health Status

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Nghia A Nguyen, MD, PhD

  Mỹ Đức Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 29, 2021
• Study Start: May 14, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)