Mỹ Đức Hospital
Ho Chi Minh City, Vietnam
NCT Number: NCT04296357
The investigators conduct a follow up of our randomized controlled trial (RCT) to investigate the development of children born from In-vitro fertilization (IVF) and In-vitro maturation (IVM), in order to give strong evidence about the safety of IVM in women with high antral follicle count or especially polycystic ovary syndrome (PCOS).
Looking for future studies?
Notify Me6 month–24 month
All sexes
Observational
Ho Chi Minh City, Vietnam
Since the birth of the first baby born from in-vitro maturation (IVM) in 1991, this technique has been considered an alternative solution for treating infertility beside conventional controlled ovarian stimulation for in-vitro fertilization (IVF). Since then, there are already more than 5000 children born from IVM, and that number is on the trend of increasing.
Regarding technique, immature oocytes (germinal vesicle - GV) were aspirated from secondary follicles sized from 2-10mm, under follicle-stimulating hormone (FSH) priming or no ovarian stimulation at all. Afterward, the maturation process was undertaken in an artificial medium, out of a living body. This technique, by reducing the usage of external hormones, is highly effective in minimizing the risk of ovarian hyperstimulation syndrome (OHSS) in women with high antral follicle count, especially polycystic ovarian syndrome, with a rate of OHSS recorded as low as 0 percent. Alongside that, the pregnancy rate, as well as the live birth rate of IVM, when proceeded well, is not lower than conventional IVF. Until now, there is only one randomized controlled trial comparing these two techniques directly.
Due to differences in the process of culturing between IVM and IVF, primarily the maturation is undertaken in an artificial medium, the health of children born from IVM received many interests. Numerous studies have been conducted to compare the development of children born from IVM and IVF. Neonatal outcomes of children born from IVM and IVF are considerably comparable. And the development of children born from these two techniques is not significantly different. All the information, as mentioned above, was not from randomized controlled trials but retrospective or prospective cohort studies. Thus, we conduct a follow up of our RCT to investigate the development of children born from IVM and IVM, to give strong evidence about the safety of IVM in women with high antral follicle count or especially PCOS.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Up to 24 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.
Time frame: Up to 24 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
Time frame: Up to 24 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
Time frame: Up to 24 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
Time frame: Up to 24 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
Time frame: Up to 24 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
Time frame: From 6 months to 24 months after birth
He or she has at least one red flag sign by age For children at 6 months: he or she
For children at 12 months: he or she
For children at 24 months: he or she
Time frame: Up to 24 months after birth
Duration of breast-feeding
Time frame: Up to 24 months after birth
Infant age at which weaning starts
Time frame: Up to 24 months after birth
Name of diseases that lead to hospital admission
Time frame: Up to 24 months after birth
Number of hospital admission
Time frame: Up to 24 months after birth
Weight on the examination date
Time frame: Up to 24 months after birth
Height on the examination date
Time frame: At birth
Gestational age at delivery
Time frame: At birth
Vaginal birth or C-section
Time frame: At birth
Weight of baby born
Time frame: At birth
Head circumference after birth Head circumference after birth Head circumference after birth Length circumference after birth
Time frame: At birth
Head circumference after birth
Time frame: At birth
Any congenital anomalies detected in baby born
Time frame: Up to 28 days after birth
Number of admission days to NICU
Time frame: Up to 28 days after birth
Respiratory distress syndrome (RDS), diagnosed as the presence of tachypnoea >60/minute, sternal recession and expiratory grunting, need for supplemental oxygen, and a radiological picture of diffuse reticulogranular shadowing with an air bronchogram
Time frame: Up to 28 days after birth
Periventricular haemorrhage II B or worse, will be diagnosed by repeated neonatal cranial ultrasound by the neonatologist according to the guidelines on neuro-imaging described by de Vries et al.
Time frame: Up to 28 days after birth
Necrotizing enterocolitis (NEC) will be diagnosed according to Bell.
Time frame: Up to 28 days after birth
Proven sepsis, will be diagnosed on the combination of clinical signs and positive blood cultures.
Time frame: Up to 28 days after birth
Composite of poor perinatal outcomes, defined as intraventricular haemorrhage, respiratory distress syndrome, necrotizing enterocolitis or neonatal sepsis.
Time frame: Up to 24 months after birth
Any long-term illness and chronic condition appears in a child
Mỹ Đức Hospital
Other
Follow-up of Children Born From In-vitro Maturation Versus In-vitro Fertilization: Follow-up of a Randomized Controlled Trial
Acronym: FM-BABIES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06369415
Development, Child, Genital Diseases
Ho Chi Minh City, Tan Binh, Vietnam
View Trial DetailsNCT06633120
AMH, Adnexal Diseases
Lone Tree, Colorado, United States
View Trial DetailsNCT05722067
Artificial Oocyte Activation, Genital Diseases
Kaohsiung City, Taiwan
View Trial DetailsNCT05873725
Genital Diseases, IVF
Montreal, Quebec, Canada
View Trial Details