NCT04296357

Health of IVF Versus IVM Children (FM-BABIES)

Follow-up of Children Born From In-vitro Maturation Versus In-vitro Fertilization: Follow-up of a Randomized Controlled Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 231 (actual)
• Sponsor: Mỹ Đức Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Infertility
• IVF
• IVM

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3	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.
OTHER	Physical development and General Health	Physical development and General health examination
DIAGNOSTIC_TEST	Developmental Red flags	Developmental Red flags Questionnaires

Timeline

• Start date: 2020-03-01
• Primary completion: 2022-01-05
• Completion: 2022-01-05
• First posted: 2020-03-05
• Last updated: 2022-02-15

Locations

1 site across 1 country: Vietnam