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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04866524
Enrollment
322
Registered
2021-04-29
Start date
2021-05-14
Completion date
2021-10-01
Last updated
2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conventional IVF, ICSI

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.

Detailed description

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.

Interventions

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 examination

Developmental Red flags Questionnaires

Sponsors

Mỹ Đức Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Months to 36 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The number of patients having abnormal ASQ-3 scores in each aspectUp to 66 months after birthASQ-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

MeasureTime frameDescription
Score of CommunicationUp to 66 months after birth6 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
Score of Gross motorUp to 66 months after birth6 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
Score of Fine motorUp to 66 months after birth6 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
Score of Problem solvingUp to 66 months after birth6 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
Score of Personal-SocialUp to 66 months after birth6 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
Duration of breast-feedingUp to 24 months after birthDuration of breast-feeding
Infant age at which weaning startsUp to 24 months after birthInfant age at which weaning starts
Name of diseases that lead to hospital admissionUp to 66 months after birthName of diseases that lead to hospital admission
WeightThrough study completion, an average of 1.5 monthsWeight on the examination date
HeightThrough study completion, an average of 1.5 monthsHeight on the examination date
The rate of children who have at least one red flag signFrom 2 to 5.5 years after birthHe 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

Other

MeasureTime frameDescription
The rate of long-term illness and chronic conditionsUp to 66 months after birthThe rate of long-term illness and chronic conditions

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026