Health of Frozen Transferred Versus Fresh Transferred Children
- Conditions
- IVFInfertility
- Registration Number
- NCT04099784
- Lead Sponsor
- Mỹ Đức Hospital
- Brief Summary
In order to give strong recommendation on the efficacy and safety of fresh versus frozen embryo transfer, we conduct this study in order to investigate the physical and mental development of children from fresh versus frozen embryo transfer. Based on our Freeze-only study (Vuong et al., 2018), the women without polycystic ovary syndrome undergoing the first or second IVF were randomly assigned to receive either fresh or frozen embryos on day 3 after oocyte retrieval, which leads to the similarity in characteristics of these two groups. Hence, the result from analysing these offsprings would be preciously valuable.
- Detailed Description
Since the first live birth after the transfer of a frozen-thawed embryo reported in 1984, cryopreservation has been considered as an enormous revolution in assisted reproductive technology (ART). It is observed that the trend of ART cycles using frozen embryo transfer is on the increase, which leads to a great deal number of children born from frozen embryos. This is the commencement of 2 embryo transfer strategies, the first one is transferring the fresh embryos, the other is freezing all the embryos and transfer them in the next cycle.
Comparing these two strategies, up till now, there are 4 published randomized control trials (RCTs) indicating different methods for certain groups of patients (Chen et al., 2016; Shi et al., 2018; Vuong et al., 2018; Wei et al., 2019). Regarding the efficacy, the freeze-all strategy outweighs the fresh embryo transfer in women with polycystic ovary syndrome (PCOS). While that efficacy gets a controversy in non-PCOS or ovulatory patients; two groups of authors indicated that these 2 strategies are equally effective, while the other group claims that the better result goes to cycles with frozen embryos. In term of safety, the rate of ovarian hyperstimulation syndrome (OHSS) is the equivalent or lower in the freeze-all group, which implies the important role of embryo-freezing in avoiding maternal risk. The question that whether freezing the embryos exerts effect on offspring is not thoroughly understood. The mostly used parameter in evaluating the safety of children is the perinatal status of infants, not the development of these children.
Searching literature, in 2010, S. Pelkonen published a large cohort study indicating that freezing the embryos do not change the rate of prematurity, low birthweight and being small for gestational age (Pelkonen et al., 2010). Looking further in our freeze-only study, our sub-analysis indicates that the livebirth weight of infants born from frozen embryos is 300 gram heavier than that from fresh embryos (Vuong et al., 2018). Following 4 studies comparing fresh and frozen embryo transfer, children from frozen embryos are similar or higher in term of newborn weight, and there is no study investigate the onward development of childrens born from these two strategies. The only proof on the development of children born from fresh verus frozen embryo is from one study with no randomization which states that children from fresh and frozen embryos share similar academic performance at the age 15-16 (Spangmose et al., 2019). We found no study investigate the impact of different embryo transfer strategies on the growth of children resulting from either fresh or frozen embryos.
In order to give strong recommendation on the efficacy and safety of fresh versus frozen embryo transfer, we conduct this study in order to investigate the physical and mental development of children from fresh versus frozen embryo transfer. Based on our Freeze-only study (Vuong et al., 2018), the women without polycystic ovary syndrome undergoing the first or second IVF were randomly assigned to receive either fresh or frozen embryos on day 3 after oocyte retrieval, which leads to the similarity in characteristics of these two groups. Hence, the result from analysing these offsprings would be preciously valuable.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
- Live babies born from the first transfer of both freeze-only and fresh embryo transfer group from our Freeze-only study.
- Parents agree to participate in the study.
- Babies died after perinatal period.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The average total ASQ-3 score 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.
ASQ-3 average = average score of 5 aspects.
- Secondary Outcome Measures
Name Time Method Duration of breast-feeding Up to 24 months after birth Duration of breast-feeding
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
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.
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.
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 2 to \< 3 year-old:
* Has very unclear speech
* Doesn't understand simple instruction • Doesn't speak in sentences
* Doesn't make eye contact
* Loses skills he/she once had
From 3 to \< 4 year-old:
* Can't jump in place
* Doesn't play pretend or make-believe • Speaks unclearly
* Can't retell a favorite story
* Doesn't use "me" and "you" correctly
* Loses skills he/she once had
From 4 to \< 5.5 year-old:
* Is easily distracted, has trouble focusing on one activity for more than 5 minutes • Doesn't talk about daily activities or experiences
* Shows extreme behavior
* Loses skills he/she once hadInfant age at which weaning starts Up to 24 months after birth Infant age at which weaning starts
Number of hospital admission Up to 66 months after birth Number of hospital admission
Name of diseases that lead to hospital admission Up to 66 months after birth Name of diseases that lead to hospital admission
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.
Score of Problem solving Up to 66 months after birth 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0.
Weight Through study completion, an average of 1.5 months Weight on the examination date
Trial Locations
- Locations (1)
Mỹ Đức Hospital
🇻🇳Ho Chi Minh City, Tan Binh, Vietnam
Mỹ Đức Hospital🇻🇳Ho Chi Minh City, Tan Binh, Vietnam