Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04866524
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2021-04-27
Brief Title:
Child Follow-up in Women Treated With Conventional IVF or ICSI
Sponsor:
Mỹ Đức Hospital
Organization:
Mỹ Đức Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 476 to 2007 652 and reached 978 in the Middle East in 2007 Ishihara et al 2015 Another survey recorded in Europe in 2011 out of a total of 437510 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 763 to 933 In particular in cases of non-male-factor infertility the incidence of ICSI also increased from 154 to 669 From 2008-2012 of 494 907 treatment cycles 746 used ICSI In which ICSI accounts for 929 of the cycle of male infertility and 645 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None