Health of IVF Versus IVM Children (FM-BABIES)

Completed

• Conditions: Infertility; IVF; IVM

• Registration Number: NCT04296357
• Lead Sponsor: Mỹ Đức Hospital

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-05
• Primary Completion: 2022-01-05
• Study Completion: 2022-01-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-12
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

• All live babies born following the In-vitro Maturation and In-vitro fertilization from our FM study.
• Parents agree to participate in the study.

Exclusion Criteria

• Babies died under or at 24 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The average total ASQ-3 score	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.

Secondary Outcome Measures

Name	Time	Method
Duration of breast-feeding	Up to 24 months after birth	Duration of breast-feeding
Name of diseases that lead to hospital admission	Up to 24 months after birth	Name of diseases that lead to hospital admission
Score of Problem solving	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
Number of hospital admission	Up to 24 months after birth	Number of hospital admission
Score of Gross motor	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
Score of Fine motor	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
Height	Up to 24 months after birth	Height on the examination date
Score of Communication	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
Score of Personal-Social	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
The rate of children who have at least one red flag sign	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; * Do not know to flip before 3 months; * Still holding hands constantly at 3 months; * Do not pay attention to the stimulation from the environment; * Poor head control; * No access to objects/ toys before 5 months; * No laughter; For children at 12 months: he or she; * No babbling before 6 months; * Unable to sit down in a W-style at 7 months; * Unable to identify audio source before 10 months; * Still holding things in your mouth often for 12 months; For children at 24 months: he or she; * Do not speak consonants before 15 months; * Do not know imitate before 16 months; * Do not know to point fingers to attract attention about objects that he or she cares about; * Show right-handedness before 18 months; * Unable to ascend and descend stairs at 24 months; * Repeat the machinery of others' words; * Not reached the single 50 marks yet by 24 months
Infant age at which weaning starts	Up to 24 months after birth	Infant age at which weaning starts
Weight	Up to 24 months after birth	Weight on the examination date

Trial Locations

Locations (1)

Mỹ Đức Hospital; 🇻🇳 Ho Chi Minh City, Vietnam