Developmental Outcomes of Children Born Through Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-male Factor Infertility
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 322
- Locations
- 1
- Primary Endpoint
- The number of patients having abnormal ASQ-3 scores in each aspect
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 12 Months to 36 Months (Child)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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
- Weight(Through study completion, an average of 1.5 months)
- Score of Communication(Up to 66 months after birth)
- The rate of children who have at least one red flag sign(From 2 to 5.5 years after birth)
- Score of Problem solving(Up to 66 months after birth)
- Height(Through study completion, an average of 1.5 months)
- Score of Fine motor(Up to 66 months after birth)
- Duration of breast-feeding(Up to 24 months after birth)
- Infant age at which weaning starts(Up to 24 months after birth)
- Score of Gross motor(Up to 66 months after birth)
- Score of Personal-Social(Up to 66 months after birth)
- Name of diseases that lead to hospital admission(Up to 66 months after birth)