Singeleton Conceived Fresh and Frozen Embryo Transfer (ICSI/IVF), Naturally ConceivedNCT04772872
NEURODEVELOPMENTAL OUTCOMES OF SINGLETON CONCEIVED FROM FRESH AND FROZEN EMBRYO TRANSFER COMPARED WITH NATURALLY CONCEIVED
An observational study of Singeleton Conceived Fresh and Frozen Embryo Transfer (ICSI/IVF), Naturally Conceived, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 2 days
- Conditions the study is for
- Singeleton Conceived Fresh and Frozen Embryo Transfer (ICSI/IVF), Naturally Conceived
- What is being tested?
- Assessment by Brazelton neonatal behavior for group A,Band C
- How many people
- 186 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 2 days
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- Singleton will be excluded from study if one or more of the following is present:
- vanishing twins (singleton birth where a twin pregnancy recorded at 7 weeks of gestational age (double heart rate at sound)).
- Preterm singleton.
- Congenital anomalies
- Gestational surrogates.
- Donor oocyte pregnant.
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- Multiple birth.
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Cairo
sally ashraf asker, assistant lecture, 01065856641, sallyasker2016@gmail.com
About this study
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.
Read the 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.
- Being tested
- Assessment by Brazelton neonatal behavior for group A,Band C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment by Brazelton neonatal behavior for group A,Band COther
Also called Assessment by new ballard score for group A,Band C, Assessment infant weight scale for group A,Band C, assessment by APGAR score for group A,B and C
- Neonatal neurobehavior will be measured by Brazelton neonatal behavior assessment scale.
- Neonatal maturity will be represented by the variance of estimated gestational age that determined by new Ballard score.
- Apgar score will be represented by the variance of degree of scores.
- Birth weight will be measured in grams.
| Study group | Role | What they receive |
|---|---|---|
| Group A:Naturally conceived singleton | * Neonatal neurobehavior will be measured by Brazelton neonatal behavior assessment scale.
* Neonatal maturity will be represented by the variance of estimated gestational age that determined by new Ballard score.
* Apgar score will be represented by the variance of degree of scores.
* Birth weight will be measured in grams. Receives: Other: Assessment by Brazelton neonatal behavior for group A,Band C | |
| Group B: Singleton conceived from fresh embryo transfer(IVF/ICSI) | * Neonatal neurobehavior will be measured by Brazelton neonatal behavior assessment scale.
* Neonatal maturity will be represented by the variance of estimated gestational age that determined by new Ballard score.
* Apgar score will be represented by the variance of degree of scores.
* Birth weight will be measured in grams. Receives: Other: Assessment by Brazelton neonatal behavior for group A,Band C | |
| Group C: Singleton conceived from frozen embryo transfer (IVF/ICSI) | * Neonatal neurobehavior will be measured by Brazelton neonatal behavior assessment scale.
* Neonatal maturity will be represented by the variance of estimated gestational age that determined by new Ballard score.
* Apgar score will be represented by the variance of degree of scores.
* Birth weight will be measured in grams. Receives: Other: Assessment by Brazelton neonatal behavior for group A,Band C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobehavior
Brazelton behavioral neonatal assessment (BNBAS) The NBAS assesses the infant's behavioral capacities, including his or her ability to respond to the environment, such as the ability to orient and habituate to visual or auditory stimuli, both animate and inanimate; the quality of motor tone and activity levels elected priories those that potentially reflect skills associated with attention
Measured: at first day of birth
maturity
New Ballard Score New Ballard score was rapid, accurate method of clinically assessing gestational maturation of newly born infants developed by Dr. Jeanne L Ballard. (Ballard et al., 1991).
The New Ballard Score is a set of procedures to determine Gestational age through neuromuscular and physical assessment of a newborn infant.:
- Neuromuscular maturity contains: posture, square window, assessing the flexibility of the wrist, arm recoil, popliteal angle, scarf sign and heel to ear.
- The physical assessment contains: skin, ear/eye, lanugo hair, plantar surface, breast bud and genitals. (Appendix III) This scoring used for the estimation of age in the range of 26 gestational weeks to 44 gestational weeks.
Measured: at first day of birth
birth weight
Weight record is essential to monitor the adequacy of nutrition as well as fluid balance. Weight of birth is the single most useful predictor of neonatal morbidity and mortality. A weighing scale for measuring the weight at birth is essential for all facilities where deliveries take place and where neonates are looked after
Measured: at first day of birth
Apgar scoring
Apgar scoring The Apgar score, the first test given to new born, assessed in the delivery or birthing room after the fetus birth. The test was designed to quickly evaluate a newborn's physical condition and to see if there is an immediate need for extra medical or emergency care. It was done at 1 minute and 5 minutes after birth, newborns are observed and rated according to the Apgar score
Measured: at first day of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Singeleton Conceived Fresh and Frozen Embryo Transfer (ICSI/IVF), Naturally ConceivedStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Ashraf Mohammed Askar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772872
- Sponsor's protocol ID
- Sasker_phd2021
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEURODEVELOPMENTAL OUTCOMES OF SINGLETON CONCEIVED FROM FRESH AND FROZEN EMBRYO TRANSFER COMPARED WITH NATURALLY CONCEIVED
- ClinicalTrials.gov ID
- NCT04772872
- Acronym / sponsor ID
- Sasker_phd2021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A:Naturally conceived singleton | – | Other: Assessment by Brazelton neonatal behavior for group A,Band C* Neonatal neurobehavior will be measured by Brazelton neonatal behavior assessment scale. * Neonatal maturity will be represented by the variance of estimated gestational age that determined by new Ballard score. * Apgar score will be represented by the variance of degree of scores. * Birth weight will be measured in grams. |
| Group B: Singleton conceived from fresh embryo transfer(IVF/ICSI) | – | Other: Assessment by Brazelton neonatal behavior for group A,Band C* Neonatal neurobehavior will be measured by Brazelton neonatal behavior assessment scale. * Neonatal maturity will be represented by the variance of estimated gestational age that determined by new Ballard score. * Apgar score will be represented by the variance of degree of scores. * Birth weight will be measured in grams. |
| Group C: Singleton conceived from frozen embryo transfer (IVF/ICSI) | – | Other: Assessment by Brazelton neonatal behavior for group A,Band C* Neonatal neurobehavior will be measured by Brazelton neonatal behavior assessment scale. * Neonatal maturity will be represented by the variance of estimated gestational age that determined by new Ballard score. * Apgar score will be represented by the variance of degree of scores. * Birth weight will be measured in grams. |
Who may qualify
- Ages
- 1 hour to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (16 listed)
- Singleton will be excluded from study if one or more of the following is present:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment by Brazelton neonatal behavior for group A,Band CAlso: Assessment by new ballard score for group A,Band C, Assessment infant weight scale for group A,Band C, assessment by APGAR score for group A,B and C* Neonatal neurobehavior will be measured by Brazelton neonatal behavior assessment scale. * Neonatal maturity will be represented by the variance of estimated gestational age that determined by new Ballard score. * Apgar score will be represented by the variance of degree of scores. * Birth weight will be measured in grams. | Other | Group A:Naturally conceived singleton, Group B: Singleton conceived from fresh embryo transfer(IVF/ICSI), Group C: Singleton conceived from frozen embryo transfer (IVF/ICSI) |
Primary outcome
Neurobehavior
Time frame: at first day of birth
Brazelton behavioral neonatal assessment (BNBAS) The NBAS assesses the infant's behavioral capacities, including his or her ability to respond to the environment, such as the ability to orient and habituate to visual or auditory stimuli, both animate and inanimate; the quality of motor tone and activity levels elected priories those that potentially reflect skills associated with attention
maturity
Time frame: at first day of birth
New Ballard Score New Ballard score was rapid, accurate method of clinically assessing gestational maturation of newly born infants developed by Dr. Jeanne L Ballard. (Ballard et al., 1991). The New Ballard Score is a set of procedures to determine Gestational age through neuromuscular and physical assessment of a newborn infant.: * Neuromuscular maturity contains: posture, square window, assessing the flexibility of the wrist, arm recoil, popliteal angle, scarf sign and heel to ear. * The physical assessment contains: skin, ear/eye, lanugo hair, plantar surface, breast bud and genitals. (Appendix III) This scoring used for the estimation of age in the range of 26 gestational weeks to 44 gestational weeks.
birth weight
Time frame: at first day of birth
Weight record is essential to monitor the adequacy of nutrition as well as fluid balance. Weight of birth is the single most useful predictor of neonatal morbidity and mortality. A weighing scale for measuring the weight at birth is essential for all facilities where deliveries take place and where neonates are looked after
Apgar scoring
Time frame: at first day of birth
Apgar scoring The Apgar score, the first test given to new born, assessed in the delivery or birthing room after the fetus birth. The test was designed to quickly evaluate a newborn's physical condition and to see if there is an immediate need for extra medical or emergency care. It was done at 1 minute and 5 minutes after birth, newborns are observed and rated according to the Apgar score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Singeleton Conceived Fresh and Frozen Embryo Transfer (ICSI/IVF), Naturally Conceived, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobehavior (time frame: at first day of birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.