Clinical trial NCT04866524: Child Follow-up in Women Treated With Conventional IVF or ICSI
Official title: Developmental Outcomes of Children Born Through Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-male Factor Infertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conventional IVF, ICSI
Lead sponsor: Mỹ Đức Hospital
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 322
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of patients having abnormal ASQ-3 scores in each aspect
timeFrame: Up to 66 months after birth
Secondary outcomes:
measure: Score of Communication
timeFrame: Up to 66 months after birth
measure: Score of Gross motor
timeFrame: Up to 66 months after birth
measure: Score of Fine motor
timeFrame: Up to 66 months after birth
measure: Score of Problem solving
timeFrame: Up to 66 months after birth
measure: Score of Personal-Social
timeFrame: Up to 66 months after birth
measure: The rate of children who have at least one red flag sign
timeFrame: From 2 to 5.5 years after birth
measure: Duration of breast-feeding
timeFrame: Up to 24 months after birth
measure: Infant age at which weaning starts
timeFrame: Up to 24 months after birth
measure: Name of diseases that lead to hospital admission
timeFrame: Up to 66 months after birth
measure: Weight
timeFrame: Through study completion, an average of 1.5 months
measure: Height
timeFrame: Through study completion, an average of 1.5 months
Other outcomes:
measure: The rate of long-term illness and chronic conditions
timeFrame: Up to 66 months after birth
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Mỹ Đức Hospital
state: Tan Binh
Study officials:
affiliation: Mỹ Đức Hospital
name: Nghia A Nguyen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: