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Completed

NCT Number: NCT04866524

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

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.

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Key information

Conditions

Conventional IVF, ICSI

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

About this study

Over the past two decades, intracytoplasmic sperm injection (ICSI) indications have been extended and routinely applied to all cases of assisted reproductive techniques: unexplained infertility, poor-quality oocytes, low oocyte yeild, advanced marternal age, prior failed fertilization with conventional insemination, after in-vitro maturation of oocytes and for cases of cryopreserved oocytes (Practice Committees of the American Society for Reproductive Medicine, 2020). In 2004, fertilization using ICSI accounted for nearly 60% of all aspirations globally. In the Middle East, the number of ICSI cycles increased rapidly from 2000 (47.6%) to 2007 (65.2%), and reached 97.8% in the Middle East in 2007 (Ishihara et al, 2015). Another survey recorded in Europe in 2011, out of a total of 437,510 cycles of fresh embryo transfer, 68% of cycles were performed using ICSI techniques. In male infertility cases, the rate of implementation of ICSI increased from 76.3% to 93.3%. In particular, in cases of non-male-factor infertility, the incidence of ICSI also increased from 15.4% to 66.9%. From 2008-2012, of 494 907 treatment cycles, 74.6% used ICSI. In which, ICSI accounts for 92.9% of the cycle of male infertility and 64.5% of the cycle of non-male-factor infertility (Boulet, 2015).

However, ICSI is an invasive technique that bypasses the natural barriers of fertilization. This has led to concern about an increase in the incidence of anomalies in ICSI-born babies as this technique is increasingly being used in all cases of contraception. In contrast, there are studies that have also compared IVF with ICSI and show that in the ICSI cycle, the incidence of multiple pregnancies and low birth weight infants is lower than that of IVF, although there is no difference in infant survival between the two groups (Boulet et al, 2015).

In addition to the short-term outcomes, the investigators also have to consider the long-term maternal and neonatal outcomes. There is still not much evidence comparing the effects of the above methods, if any, on the psychomotor development in children.

Therefore, the investigators decide to conduct a study 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Babies died after the perinatal period.

Treatment and study plan

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.

Physical development and General Health

Other

Physical development and General health examination

Developmental Red flags

Other

Developmental Red flags Questionnaires

Primary outcomes

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

    Time frame: Up to 66 months after birth

    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.

Secondary outcomes

  1. Score of Communication

    Time frame: Up to 66 months after birth

    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

  2. Score of Gross motor

    Time frame: Up to 66 months after birth

    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

  3. Score of Fine motor

    Time frame: Up to 66 months after birth

    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

  4. Score of Problem solving

    Time frame: Up to 66 months after birth

    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

  5. Score of Personal-Social

    Time frame: Up to 66 months after birth

    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

  6. The rate of children who have at least one red flag sign

    Time frame: From 2 to 5.5 years after birth

    He or she has at least one red flag sign by age:

    From 12 to < 18 month-old:

    • Doesn't crawl
    • Can't stand when supported
    • Doesn't search for things that he/she sees the participants hide
    • Doesn't say single words ("baba", "mama"...)
    • Doesn't learn gestures like waving or shaking head
    • Doesn't point to things
    • Loses skills he/she once had

    From 18 to < 24 month-old:

    • Doesn't point to show things to others
    • Can't walk
    • Doesn't know what familiar things are for
    • Doesn't gain new words
    • Doesn't have at least 6 words
    • Doesn't notice or mind when a caregiver leaves or returns
    • Lose skills he once had

    From 24 to < 36 month-old:

    • Doesn't use 2-word phrases
    • Doesn't know what to do with common things, like a brush, spoon
    • Doesn't copy actions and words
    • Doesn't follow simple instructions
    • Doesn't walk steadily
    • Loses skills he/she once had

  7. Duration of breast-feeding

    Time frame: Up to 24 months after birth

    Duration of breast-feeding

  8. Infant age at which weaning starts

    Time frame: Up to 24 months after birth

    Infant age at which weaning starts

  9. Name of diseases that lead to hospital admission

    Time frame: Up to 66 months after birth

    Name of diseases that lead to hospital admission

  10. Weight

    Time frame: Through study completion, an average of 1.5 months

    Weight on the examination date

  11. Height

    Time frame: Through study completion, an average of 1.5 months

    Height on the examination date

Other outcomes

  1. The rate of long-term illness and chronic conditions

    Time frame: Up to 66 months after birth

    The rate of long-term illness and chronic conditions

Sponsors and collaborators

Lead sponsor

Mỹ Đức Hospital

Other

Registry information

Official study title

Developmental Outcomes of Children Born Through Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-male Factor Infertility

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2021
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.