Clinical trial NCT04772872: NEURODEVELOPMENTAL OUTCOMES OF SINGLETON CONCEIVED FROM FRESH AND FROZEN EMBRYO TRANSFER COMPARED WITH NATURALLY CONCEIVED
Official title: NEURODEVELOPMENTAL OUTCOMES OF SINGLETON CONCEIVED FROM FRESH AND FROZEN EMBRYO TRANSFER COMPARED WITH NATURALLY CONCEIVED
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Singeleton Conceived Fresh and Frozen Embryo Transfer (ICSI/IVF), Naturally Conceived
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 186
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 186 full term singletons born through IVF/ICSI after 37 weeks of gestation and from naturally conceived will be enrolled in this study

Brief summary: This study aimed to: detect difference in neurobehavior, maturity, Apgar score and birth weight of singleton conceived from fresh and frozen embryo transfer and naturally conceived.

Detailed description: The use of ART has increased significantly during the past decades with more than 390000 children born worldwide annually and the total number of ART children now exceeding 7 million (Adamson et al., 2018). ART is associated with an increased risk of perinatal complications, including preterm birth (PTB) and small for gestational age (SGA) (Pandey et al., 2012 and Pinborg et al., 2013).

When mothers had been received ovarian stimulation in ART, multiple follicles and corpora lutea are produced, which produce supraphysiologic serum levels of multiple hormones and other factors, including estradiol, progesterone, and vascular endothelial growth factor (VEGF). This non physiological hormonal milieu affects both the endometrium and the embryo, potentially resulting in altered growth of the developing fetus. There was a serious effect of the supraphysiologic hormonal environment on pregnancy outcomes. (Imudia et al., 2012).

Neonates born after an IVF/ICSI procedure have an increased risk of various developmental problems, neurological disabilities, impairments or handicap, especially the cerebral palsy (CP) (Strömberg et al., 2002 and Squires and Kaplan, 2007).The increased risk of prematurity and smaller birth weight after an ART procedure required regular periodic screening and careful developmental follow-up of these children. (Boulet et al., 2008).

Singleton born after an IVF procedure were more likely to need habilitation treatment and had increased risk of developing neurological problems, especially cerebral palsy (CP), suspicion for a delay in their development. (Strömberg et al., 2002) Children born after an IVF procedure had three times higher presence of CP compared to the children from the general population and the risk of suspicion for a delay in their development was four times higher in children born after an IVF procedure than in the naturally conceived. (Strömberg et al., 2002). There is evidence of associations among the ART procedure and the developmental delay (Hvidtjørn et al., 2009).

The lack of early examination of neonates׳s neurobehavior conceived from ICSI/IVF may be led to developmental delay in these neonates. Early detection of neurobehavior deviation is essential for effective control of this potentially debilitating morbidity. As there is no available data about neurobehavior of Egyptian neonates conceived from frozen and fresh embryo transfer so there is an arising need to address this gap of knowledge.

Thus, to overcome previous limitation, the current study aimed to evaluate neurobehavior of singletons conceived from fresh and frozen embryo transfer compared with naturally conceived and screening for identify need for early intervention and developmental follow up to prevent worsening and progression of dysfunctions.

Eligibility criteria: Inclusion Criteria:

* Singleton born through IVF/ICSI (frozen embryo transfer and fresh embryo transfer) after 37 weeks of gestation.
* Singleton whose mothers are aged from 25 to 35 years old and has BMI ranged from 18.5 to 29.

Exclusion Criteria:

* Singleton will be excluded from study if one or more of the following is present:

  1. vanishing twins (singleton birth where a twin pregnancy recorded at 7 weeks of gestational age (double heart rate at sound)).
  2. Preterm singleton.
  3. Congenital anomalies
  4. Gestational surrogates.
  5. Donor oocyte pregnant.
  6. Multiple birth.
  7. Singleton whose mothers have

     * Metabolic diseases (hypertension and diabetes).
     * Chronic health issues (asthma and epilepsy).
     * Gestational condition (preeclampsia, impaired glucose tolerance, gestational diabetes, anemia and ULT occurrence).
     * Placenta previa and placenta accrete.
     * Premature rapture of membrane.
     * Premature uterine contraction.
     * Cervical insufficiency.
     * Smoker mother.

Primary outcomes:
measure: Neurobehavior
timeFrame: at first day of birth
measure: maturity
timeFrame: at first day of birth
measure: birth weight
timeFrame: at first day of birth
measure: Apgar scoring
timeFrame: at first day of birth
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References: