Child Follow-up in Women Treated With Conventional IVF or ICSI
Condition: Conventional IVF, ICSI
Study type: Observational

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.
    

Intervention name(s): Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Physical development and General Health; Developmental Red flags
Intervention type(s): Other; Other; Other
Intervention description(s): 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
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)