Child Follow-up in Women Treated With Conventional IVF or ICSI
- Conditions
- Conventional IVF, ICSI
- Interventions
- Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3Other: Physical development and General HealthOther: Developmental Red flags
- Registration Number
- NCT04866524
- Lead Sponsor
- Mỹ Đức Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 322
- Live babies born from ICSI Versus Conventional IVF in Non-male Factor Couples (NCT03428919)
- Parents agree to participate in the study.
- Babies died after the perinatal period.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Conventional IVF Developmental Red flags In conventional IVF group, insemination will be performed by conventional IVF. Two hours after retrieval, collected OCCs will be inseminated for another 2 hours, at a concentration of 100,000 motile sperm/ml. Inseminated OCCs will be cultured overnight in culture medium. ICSI technique Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 In ICSI group, insemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. OCCs will be stripped by using hyaluronidase. Only matured oocytes will be inseminated. ICSI technique Physical development and General Health In ICSI group, insemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. OCCs will be stripped by using hyaluronidase. Only matured oocytes will be inseminated. ICSI technique Developmental Red flags In ICSI group, insemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. OCCs will be stripped by using hyaluronidase. Only matured oocytes will be inseminated. Conventional IVF Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 In conventional IVF group, insemination will be performed by conventional IVF. Two hours after retrieval, collected OCCs will be inseminated for another 2 hours, at a concentration of 100,000 motile sperm/ml. Inseminated OCCs will be cultured overnight in culture medium. Conventional IVF Physical development and General Health In conventional IVF group, insemination will be performed by conventional IVF. Two hours after retrieval, collected OCCs will be inseminated for another 2 hours, at a concentration of 100,000 motile sperm/ml. Inseminated OCCs will be cultured overnight in culture medium.
- Primary Outcome Measures
Name Time Method The number of patients having abnormal ASQ-3 scores in each aspect 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 Outcome Measures
Name Time Method Weight Through study completion, an average of 1.5 months Weight on the examination date
Score of Communication Up to 66 months after birth 6 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
The rate of children who have at least one red flag sign From 2 to 5.5 years after birth He 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 hadScore of Problem solving Up to 66 months after birth 6 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
Height Through study completion, an average of 1.5 months Height on the examination date
Score of Fine motor Up to 66 months after birth 6 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-feeding Up to 24 months after birth Duration of breast-feeding
Infant age at which weaning starts Up to 24 months after birth Infant age at which weaning starts
Score of Gross motor Up to 66 months after birth 6 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-Social Up to 66 months after birth 6 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
Name of diseases that lead to hospital admission Up to 66 months after birth Name of diseases that lead to hospital admission
Trial Locations
- Locations (1)
Mỹ Đức Hospital
🇻🇳Ho Chi Minh City, Tan Binh, Vietnam