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Completed

NCT Number: NCT04296357

Health of IVF Versus IVM Children (FM-BABIES)

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).

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Key information

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Mỹ Đức Hospital

Ho Chi Minh City, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3

Diagnostic Test

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

Other

Physical development and General health examination

Developmental Red flags

Diagnostic Test

Developmental Red flags Questionnaires

Primary outcomes

  1. The average total ASQ-3 score

    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.

Secondary outcomes

  1. Score of Communication

    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

  2. Score of Gross motor

    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

  3. Score of Fine motor

    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

  4. Score of Problem solving

    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

  5. Score of Personal-Social

    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

  6. The rate of children who have at least one red flag sign

    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

    • 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
  7. Duration of breast-feeding

    Time frame: Up to 24 months after birth

    Duration of breast-feeding

  8. Infant age at which weaning starts

    Time frame: Up to 24 months after birth

    Infant age at which weaning starts

  9. Name of diseases that lead to hospital admission

    Time frame: Up to 24 months after birth

    Name of diseases that lead to hospital admission

  10. Number of hospital admission

    Time frame: Up to 24 months after birth

    Number of hospital admission

  11. Weight

    Time frame: Up to 24 months after birth

    Weight on the examination date

  12. Height

    Time frame: Up to 24 months after birth

    Height on the examination date

Other outcomes

  1. Gestational age at delivery

    Time frame: At birth

    Gestational age at delivery

  2. Mode of delivery

    Time frame: At birth

    Vaginal birth or C-section

  3. Birth weight

    Time frame: At birth

    Weight of baby born

  4. Length circumference

    Time frame: At birth

    Head circumference after birth Head circumference after birth Head circumference after birth Length circumference after birth

  5. Head circumference

    Time frame: At birth

    Head circumference after birth

  6. Rate of congenital anomalies

    Time frame: At birth

    Any congenital anomalies detected in baby born

  7. Length of neonatal intensive care unit (NICU) admission

    Time frame: Up to 28 days after birth

    Number of admission days to NICU

  8. Rate of Respiratory distress syndrome

    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

  9. Rate of Periventricular haemorrhage

    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.

  10. Rate of Necrotizing enterocolitis

    Time frame: Up to 28 days after birth

    Necrotizing enterocolitis (NEC) will be diagnosed according to Bell.

  11. Rate of Proven sepsis

    Time frame: Up to 28 days after birth

    Proven sepsis, will be diagnosed on the combination of clinical signs and positive blood cultures.

  12. Rate of Composite of poor perinatal outcomes

    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.

  13. The rate of long-term illness and chronic conditions

    Time frame: Up to 24 months after birth

    Any long-term illness and chronic condition appears in a child

Sponsors and collaborators

Lead sponsor

Mỹ Đức Hospital

Other

Registry information

Official study title

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

Acronym: FM-BABIES

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2020
Registry last updated
Feb 15, 2022

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.

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