InfertilityNCT05578118
Health of Children Born From ICSI With AOA (AOA-BABIES)
An observational study of Infertility and Intracytoplasmic Sperm Injection, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
The investigators follow up on the development of children born from ICSI-AOA using the Developmental Red Flags and Ages \& Stages Third Edition (ASQ-3) Questionnaires to give strong evidence about the safety of AOA in assisted reproductive technology. Read more about this study
- Who is it for?
- Ages 12 to 12 months
- Conditions the study is for
- Infertility, Intracytoplasmic Sperm Injection
- How many people
- 63 participants
- Where
- 1 siteVietnam
- Study dates
- 23 Oct 2022to 30 Mar 2023
- 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 12 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: In the ICSI+AOA group, indications of AOA are: * Previous failed IVF treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes<35%) or poor embryo result (number of embryos/pick-up oocytes<35%, <3 embryos, no good-quality embryo) * Using sperm after retrieval technique, cryptozoospermia In the Control group, the indications of AOA for the next IVF cycle (if patients continue the next IVF cycle) are: * Currently failed IVF treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes<35%) or poor embryo result (number of embryos/pick-up oocytes<35%, <3 embryos, no good-quality embryo)
Who may be able to join
- All single, live babies born following ICSI with AOA and ICSI without AOA from 08/2020 to 04/2021.
- Parents consent to participate in the study. Group ICSI+AOA: Embryos from ICSI with AOA with calcium ionophore
- In the ICSI+AOA group, indications of AOA are:
- Previous failed IVF treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes<35%) or poor embryo result (number of embryos/pick-up oocytes<35%, <3 embryos, no good-quality embryo)
- Using sperm after retrieval technique, cryptozoospermia Group Control: Embryos from ICSI without AOA.
- In the Control group, the indications of AOA for the next IVF cycle (if patients continue the next IVF cycle) are:
- Currently failed IVF treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes<35%) or poor embryo result (number of embryos/pick-up oocytes<35%, <3 embryos, no good-quality embryo)
Who cannot join
- Embryos with PGT. Oocyte donation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical, Mental, and Motor Development of Children Born From Intracytoplasmic Sperm Injection With Assisted Oocyte Activation With Calcium Ionophore
The investigators follow up on the development of children born from ICSI-AOA using the Developmental Red Flags and Ages \& Stages Third Edition (ASQ-3) Questionnaires to give strong evidence about the safety of AOA in assisted reproductive technology.
Read the detailed description
Intracytoplasmic sperm injection (ICSI) is the most widely utilized assisted reproductive technique (ART) worldwide. Fertilization rates obtained after ICSI treatment are reported between 70 and 80%, representing the most efficient ART; however, complete post-ICSI fertilization failure still occurs in 3-5% of cases.
The leading cause of failed fertilization is failure to achieve oocyte activation, a crucial stage in the initiation of embryo development during fertilization. Assisted oocyte activation (AOA) using a calcium ionophore has been used for over a decade following ICSI fertilization failure. AOA is not considered a routine practice of ART yet, which is only suitable for patients with proper indications, including (i) total fertilization failure or low fertilization rate (<30%) in the previous IVF; (ii) severe male factor infertility; (iii) patients with a history of embryo arrest or poor embryo quality in previous IVF cycle.
Regarding technique, the artificial rise of induced calcium rises cannot precisely mimic the physiologically sperm-induced calcium oscillations. Little is known yet about the possible adverse effects of ionophores on post-implantation embryo development. Numerous studies have been conducted to compare the development of children born from ICSI - AOA versus non-AOA. Thus, the investigators performed this study to investigate the physical, mental, and motor development of children born following ICSI - AOA using the Developmental Red Flags and Ages \& Stages Third Edition (ASQ-3) Questionnaires.
- Conditions
- Infertility, Intracytoplasmic Sperm Injection
- Keywords
- ICSI, Total fertilization failure, AOA, ASQ-3, Health of children
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICSI + AOA | Children born after ICSI + AOA | |
| Control | Children born after ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of abnormal ASQ-3 score
ASQ-3 (Ages and Stages Questionaires®) has 5 aspects: Communication, Gross Motor, Fine Motor, Problem-solving, and Personal-Social Each element has 6 questions. If the answer is Yes, score = 10, Sometimes = 5, and Not yet = 0.
ASQ-3 average = average score of 5 aspects.
Measured: 12 months after birth
Secondary outcomes (12)
Score of Communication
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 aspect in each stage has an alternative threshold.
Measured: 12 months after birth
Score of Gross motor
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 aspect in each stage has an alternative threshold.
Measured: 12 months after birth
Score of Fine motor
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 aspect in each stage has an alternative threshold.
Measured: 12 months after birth
Score of Problem-solving skill
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 aspect in each stage has an alternative threshold.
Measured: 12 months after birth
Score of Personal-Social
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 aspect in each stage has an alternative threshold.
Measured: 12 months after birth
The rate of children who have at least one red flag sign(s):
For children at 12 months: they
- No response when being called by their name
- Does not understand "no"
- Can not stand even when being supported
- Apathy or non-observance of the caregiver
- Does not look at the point where the caregiver points
Measured: 12 months after birth
Duration of breastfeeding
Duration of breastfeeding
Measured: 12 months after birth
Infant age at which weaning starts
Infant age at which weaning starts
Measured: 12 months after birth
Name of diseases that lead to hospital admission
Name of diseases that lead to hospital admission
Measured: 12 months after birth
Number of hospital admission
Number of hospital admission
Measured: 12 months after birth
Weight
Weight on the examination date
Measured: 12 months after birth
Height
Height on the examination date
Measured: 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start23 Oct 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Vuong Ngoc, PhD, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578118
- Sponsor's protocol ID
- 10/22/DD-BVMD
- Status last verified
- Aug 2023
- First submitted
- 10 Oct 2022
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alberio R, Zakhartchenko V, Motlik J, Wolf E. Mammalian oocyte activation: lessons from the sperm and implications for nuclear transfer. Int J Dev Biol. 2001 Oct;45(7):797-809.
PubMed 11732839Bos-Mikich A, Whittingham DG, Jones KT. Meiotic and mitotic Ca2+ oscillations affect cell composition in resulting blastocysts. Dev Biol. 1997 Feb 1;182(1):172-9. doi: 10.1006/dbio.1996.8468.
PubMed 9073459Capalbo A, Ottolini CS, Griffin DK, Ubaldi FM, Handyside AH, Rienzi L. Artificial oocyte activation with calcium ionophore does not cause a widespread increase in chromosome segregation errors in the second meiotic division of the oocyte. Fertil Steril. 2016 Mar;105(3):807-814.e2. doi: 10.1016/j.fertnstert.2015.11.017. Epub 2015 Dec 1.
PubMed 26658129D'haeseleer E, Vanden Meerschaut F, Bettens K, Luyten A, Gysels H, Thienpont Y, De Witte G, Heindryckx B, Oostra A, Roeyers H, Sutter PD, van Lierde K. Language development of children born following intracytoplasmic sperm injection (ICSI) combined with assisted oocyte activation (AOA). Int J Lang Commun Disord. 2014 Nov;49(6):702-9. doi: 10.1111/1460-6984.12100. Epub 2014 May 26.
PubMed 24861451Ducibella T, Huneau D, Angelichio E, Xu Z, Schultz RM, Kopf GS, Fissore R, Madoux S, Ozil JP. Egg-to-embryo transition is driven by differential responses to Ca(2+) oscillation number. Dev Biol. 2002 Oct 15;250(2):280-91.
PubMed 12376103Ebner T, Oppelt P, Wober M, Staples P, Mayer RB, Sonnleitner U, Bulfon-Vogl S, Gruber I, Haid AE, Shebl O. Treatment with Ca2+ ionophore improves embryo development and outcome in cases with previous developmental problems: a prospective multicenter study. Hum Reprod. 2015 Jan;30(1):97-102. doi: 10.1093/humrep/deu285. Epub 2014 Nov 5.
PubMed 25376461Fawzy M, Emad M, Mahran A, Sabry M, Fetih AN, Abdelghafar H, Rasheed S. Artificial oocyte activation with SrCl2 or calcimycin after ICSI improves clinical and embryological outcomes compared with ICSI alone: results of a randomized clinical trial. Hum Reprod. 2018 Sep 1;33(9):1636-1644. doi: 10.1093/humrep/dey258.
PubMed 30099496Heytens E, Soleimani R, Lierman S, De Meester S, Gerris J, Dhont M, Van der Elst J, De Sutter P. Effect of ionomycin on oocyte activation and embryo development in mouse. Reprod Biomed Online. 2008 Dec;17(6):764-71. doi: 10.1016/s1472-6483(10)60403-8.
PubMed 19079959Hirata, K., Nakamura, Y., Hattori, H., Kuchiki, M., Sakamoto, E., & Kyono, K. (2013). Follow-up child growth regarding new technologies: Testicular sperm extraction (TESE), in vitro maturation (IVM), and assisted oocyte activation (AOA). Fertility and Sterility, 100(3), S470. https://doi.org/10.1016/j.fertnstert.2013.07.445
Kashir J, Nomikos M, Lai FA, Swann K. Sperm-induced Ca2+ release during egg activation in mammals. Biochem Biophys Res Commun. 2014 Aug 1;450(3):1204-11. doi: 10.1016/j.bbrc.2014.04.078. Epub 2014 Apr 21.
PubMed 24769204Kim BY, Yoon SY, Cha SK, Kwak KH, Fissore RA, Parys JB, Yoon TK, Lee DR. Alterations in calcium oscillatory activity in vitrified mouse eggs impact on egg quality and subsequent embryonic development. Pflugers Arch. 2011 May;461(5):515-26. doi: 10.1007/s00424-011-0955-0. Epub 2011 Mar 23.
PubMed 21431324Koo OJ, Jang G, Kwon DK, Kang JT, Kwon OS, Park HJ, Kang SK, Lee BC. Electrical activation induces reactive oxygen species in porcine embryos. Theriogenology. 2008 Oct 15;70(7):1111-8. doi: 10.1016/j.theriogenology.2008.06.031.
PubMed 18675447Miller N, Biron-Shental T, Sukenik-Halevy R, Klement AH, Sharony R, Berkovitz A. Oocyte activation by calcium ionophore and congenital birth defects: a retrospective cohort study. Fertil Steril. 2016 Sep 1;106(3):590-596.e2. doi: 10.1016/j.fertnstert.2016.04.025. Epub 2016 Apr 30.
PubMed 27143515Ozil JP, Huneau D. Activation of rabbit oocytes: the impact of the Ca2+ signal regime on development. Development. 2001 Mar;128(6):917-28. doi: 10.1242/dev.128.6.917.
PubMed 11222146Ozil JP, Banrezes B, Toth S, Pan H, Schultz RM. Ca2+ oscillatory pattern in fertilized mouse eggs affects gene expression and development to term. Dev Biol. 2006 Dec 15;300(2):534-44. doi: 10.1016/j.ydbio.2006.08.041. Epub 2006 Aug 25.
PubMed 16996050
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical, Mental, and Motor Development of Children Born From Intracytoplasmic Sperm Injection With Assisted Oocyte Activation With Calcium Ionophore
- ClinicalTrials.gov ID
- NCT05578118
- Acronym / sponsor ID
- 10/22/DD-BVMD
- Conditions
- Infertility, Intracytoplasmic Sperm Injection
- Keywords
- ICSI, Total fertilization failure, AOA, ASQ-3, Health of children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 23 Oct 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 13 Oct 2022 (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.
The investigators follow up on the development of children born from ICSI-AOA using the Developmental Red Flags and Ages \& Stages Third Edition (ASQ-3) Questionnaires to give strong evidence about the safety of AOA in assisted reproductive technology.
Detailed description
Intracytoplasmic sperm injection (ICSI) is the most widely utilized assisted reproductive technique (ART) worldwide. Fertilization rates obtained after ICSI treatment are reported between 70 and 80%, representing the most efficient ART; however, complete post-ICSI fertilization failure still occurs in 3-5% of cases.
The leading cause of failed fertilization is failure to achieve oocyte activation, a crucial stage in the initiation of embryo development during fertilization. Assisted oocyte activation (AOA) using a calcium ionophore has been used for over a decade following ICSI fertilization failure. AOA is not considered a routine practice of ART yet, which is only suitable for patients with proper indications, including (i) total fertilization failure or low fertilization rate (<30%) in the previous IVF; (ii) severe male factor infertility; (iii) patients with a history of embryo arrest or poor embryo quality in previous IVF cycle.
Regarding technique, the artificial rise of induced calcium rises cannot precisely mimic the physiologically sperm-induced calcium oscillations. Little is known yet about the possible adverse effects of ionophores on post-implantation embryo development. Numerous studies have been conducted to compare the development of children born from ICSI - AOA versus non-AOA. Thus, the investigators performed this study to investigate the physical, mental, and motor development of children born following ICSI - AOA using the Developmental Red Flags and Ages \& Stages Third Edition (ASQ-3) Questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICSI + AOA | – | –Children born after ICSI + AOA |
| Control | – | –Children born after ICSI |
Who may qualify
- Ages
- 12 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- In the ICSI+AOA group, indications of AOA are: * Previous failed IVF treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes<35%) or poor embryo result (number of embryos/pick-up oocytes<35%, <3 embryos, no good-quality embryo) * Using sperm after retrieval technique, cryptozoospermia In the Control group, the indications of AOA for the next IVF cycle (if patients continue the next IVF cycle) are: * Currently failed IVF treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes<35%) or poor embryo result (number of embryos/pick-up oocytes<35%, <3 embryos, no good-quality embryo)
Key inclusion criteria (7 listed)
- All single, live babies born following ICSI with AOA and ICSI without AOA from 08/2020 to 04/2021.
- Parents consent to participate in the study. Group ICSI+AOA: Embryos from ICSI with AOA with calcium ionophore
- Previous failed IVF treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes<35%) or poor embryo result (number of embryos/pick-up oocytes<35%, <3 embryos, no good-quality embryo)
- Using sperm after retrieval technique, cryptozoospermia Group Control: Embryos from ICSI without AOA.
- In the Control group, the indications of AOA for the next IVF cycle (if patients continue the next IVF cycle) are:
Key exclusion criteria (1 listed)
- Embryos with PGT. Oocyte donation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of abnormal ASQ-3 score
Time frame: 12 months after birth
ASQ-3 (Ages and Stages Questionaires®) has 5 aspects: Communication, Gross Motor, Fine Motor, Problem-solving, and Personal-Social Each element has 6 questions. If the answer is Yes, score = 10, Sometimes = 5, and Not yet = 0. ASQ-3 average = average score of 5 aspects.
12 secondary outcomes
Score of Communication
Time frame: 12 months after birth
Score of Gross motor
Time frame: 12 months after birth
Score of Fine motor
Time frame: 12 months after birth
Score of Problem-solving skill
Time frame: 12 months after birth
Score of Personal-Social
Time frame: 12 months after birth
The rate of children who have at least one red flag sign(s):
Time frame: 12 months after birth
Duration of breastfeeding
Time frame: 12 months after birth
Infant age at which weaning starts
Time frame: 12 months after birth
Name of diseases that lead to hospital admission
Time frame: 12 months after birth
Number of hospital admission
Time frame: 12 months after birth
Weight
Time frame: 12 months after birth
Height
Time frame: 12 months after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Results publication: PubMed 11732839Alberio R, Zakhartchenko V, Motlik J, Wolf E. Mammalian oocyte activation: lessons from the sperm and implications for nuclear transfer. Int J Dev Biol. 2001 Oct;45(7):797-809.
- Results publication: PubMed 9073459Bos-Mikich A, Whittingham DG, Jones KT. Meiotic and mitotic Ca2+ oscillations affect cell composition in resulting blastocysts. Dev Biol. 1997 Feb 1;182(1):172-9. doi: 10.1006/dbio.1996.8468.
- Results publication: PubMed 26658129Capalbo A, Ottolini CS, Griffin DK, Ubaldi FM, Handyside AH, Rienzi L. Artificial oocyte activation with calcium ionophore does not cause a widespread increase in chromosome segregation errors in the second meiotic division of the oocyte. Fertil Steril. 2016 Mar;105(3):807-814.e2. doi: 10.1016/j.fertnstert.2015.11.017. Epub 2015 Dec 1.
- Results publication: PubMed 24861451D'haeseleer E, Vanden Meerschaut F, Bettens K, Luyten A, Gysels H, Thienpont Y, De Witte G, Heindryckx B, Oostra A, Roeyers H, Sutter PD, van Lierde K. Language development of children born following intracytoplasmic sperm injection (ICSI) combined with assisted oocyte activation (AOA). Int J Lang Commun Disord. 2014 Nov;49(6):702-9. doi: 10.1111/1460-6984.12100. Epub 2014 May 26.
- Results publication: PubMed 12376103Ducibella T, Huneau D, Angelichio E, Xu Z, Schultz RM, Kopf GS, Fissore R, Madoux S, Ozil JP. Egg-to-embryo transition is driven by differential responses to Ca(2+) oscillation number. Dev Biol. 2002 Oct 15;250(2):280-91.
- Results publication: PubMed 25376461Ebner T, Oppelt P, Wober M, Staples P, Mayer RB, Sonnleitner U, Bulfon-Vogl S, Gruber I, Haid AE, Shebl O. Treatment with Ca2+ ionophore improves embryo development and outcome in cases with previous developmental problems: a prospective multicenter study. Hum Reprod. 2015 Jan;30(1):97-102. doi: 10.1093/humrep/deu285. Epub 2014 Nov 5.
- Results publication: PubMed 30099496Fawzy M, Emad M, Mahran A, Sabry M, Fetih AN, Abdelghafar H, Rasheed S. Artificial oocyte activation with SrCl2 or calcimycin after ICSI improves clinical and embryological outcomes compared with ICSI alone: results of a randomized clinical trial. Hum Reprod. 2018 Sep 1;33(9):1636-1644. doi: 10.1093/humrep/dey258.
- Results publication: PubMed 19079959Heytens E, Soleimani R, Lierman S, De Meester S, Gerris J, Dhont M, Van der Elst J, De Sutter P. Effect of ionomycin on oocyte activation and embryo development in mouse. Reprod Biomed Online. 2008 Dec;17(6):764-71. doi: 10.1016/s1472-6483(10)60403-8.
- Results publicationHirata, K., Nakamura, Y., Hattori, H., Kuchiki, M., Sakamoto, E., & Kyono, K. (2013). Follow-up child growth regarding new technologies: Testicular sperm extraction (TESE), in vitro maturation (IVM), and assisted oocyte activation (AOA). Fertility and Sterility, 100(3), S470. https://doi.org/10.1016/j.fertnstert.2013.07.445
- Results publication: PubMed 24769204Kashir J, Nomikos M, Lai FA, Swann K. Sperm-induced Ca2+ release during egg activation in mammals. Biochem Biophys Res Commun. 2014 Aug 1;450(3):1204-11. doi: 10.1016/j.bbrc.2014.04.078. Epub 2014 Apr 21.
- Results publication: PubMed 21431324Kim BY, Yoon SY, Cha SK, Kwak KH, Fissore RA, Parys JB, Yoon TK, Lee DR. Alterations in calcium oscillatory activity in vitrified mouse eggs impact on egg quality and subsequent embryonic development. Pflugers Arch. 2011 May;461(5):515-26. doi: 10.1007/s00424-011-0955-0. Epub 2011 Mar 23.
- Results publication: PubMed 18675447Koo OJ, Jang G, Kwon DK, Kang JT, Kwon OS, Park HJ, Kang SK, Lee BC. Electrical activation induces reactive oxygen species in porcine embryos. Theriogenology. 2008 Oct 15;70(7):1111-8. doi: 10.1016/j.theriogenology.2008.06.031.
- Individual participant dataSharing planned: Undecided
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Lan Vuong Ngoc, PhD principal investigator
Mỹ Đức Hospital
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 Infertility and Intracytoplasmic Sperm Injection, run by Mỹ Đức Hospital at 1 site in Vietnam.
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 7 inclusion and 1 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: finished, as of the sponsor's last update on 15 Apr 2025. 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 Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of abnormal ASQ-3 score (time frame: 12 months after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05578118, which also lists 23 linked publications.
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 15 Apr 2025.