InfertilityNCT04099784
Health of Frozen Transferred Versus Fresh Transferred Children
An observational study of Infertility and IVF, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
In order to give strong recommendation on the efficacy and safety of fresh versus frozen embryo transfer, we conduct this study in order to investigate the physical and mental development of children from fresh versus frozen embryo transfer. Read more about this study
- Who is it for?
- Ages 1 month to 66 monthsHealthy volunteers can take part
- Conditions the study is for
- Infertility, IVF
- What is being tested?
- Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Physical development and General Health and Developmental Red flags
- How many people
- 255 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Sep 2019to 20 Nov 2019
- 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 month to 66 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Live babies born following the frozen embryo transfer and fresh embryo transfer from our Freeze-only study (NCT02471573)
Who may be able to join
- Live babies born from the first transfer of both freeze-only and fresh embryo transfer group from our Freeze-only study.
- Parents agree to participate in the study.
Who cannot join
- Babies died after perinatal period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up of Children Born From Freeze-only Versus Fresh Embryo Transfer: a Follow-up of a Randomized Controlled Trial
In order to give strong recommendation on the efficacy and safety of fresh versus frozen embryo transfer, we conduct this study in order to investigate the physical and mental development of children from fresh versus frozen embryo transfer. Based on our Freeze-only study (Vuong et al., 2018), the women without polycystic ovary syndrome undergoing the first or second IVF were randomly assigned to receive either fresh or frozen embryos on day 3 after oocyte retrieval, which leads to the similarity in characteristics of these two groups. Hence, the result from analysing these offsprings would be preciously valuable.
Read the detailed description
Since the first live birth after the transfer of a frozen-thawed embryo reported in 1984, cryopreservation has been considered as an enormous revolution in assisted reproductive technology (ART). It is observed that the trend of ART cycles using frozen embryo transfer is on the increase, which leads to a great deal number of children born from frozen embryos. This is the commencement of 2 embryo transfer strategies, the first one is transferring the fresh embryos, the other is freezing all the embryos and transfer them in the next cycle.
Comparing these two strategies, up till now, there are 4 published randomized control trials (RCTs) indicating different methods for certain groups of patients (Chen et al., 2016; Shi et al., 2018; Vuong et al., 2018; Wei et al., 2019). Regarding the efficacy, the freeze-all strategy outweighs the fresh embryo transfer in women with polycystic ovary syndrome (PCOS). While that efficacy gets a controversy in non-PCOS or ovulatory patients; two groups of authors indicated that these 2 strategies are equally effective, while the other group claims that the better result goes to cycles with frozen embryos. In term of safety, the rate of ovarian hyperstimulation syndrome (OHSS) is the equivalent or lower in the freeze-all group, which implies the important role of embryo-freezing in avoiding maternal risk. The question that whether freezing the embryos exerts effect on offspring is not thoroughly understood. The mostly used parameter in evaluating the safety of children is the perinatal status of infants, not the development of these children.
Searching literature, in 2010, S. Pelkonen published a large cohort study indicating that freezing the embryos do not change the rate of prematurity, low birthweight and being small for gestational age (Pelkonen et al., 2010). Looking further in our freeze-only study, our sub-analysis indicates that the livebirth weight of infants born from frozen embryos is 300 gram heavier than that from fresh embryos (Vuong et al., 2018). Following 4 studies comparing fresh and frozen embryo transfer, children from frozen embryos are similar or higher in term of newborn weight, and there is no study investigate the onward development of childrens born from these two strategies. The only proof on the development of children born from fresh verus frozen embryo is from one study with no randomization which states that children from fresh and frozen embryos share similar academic performance at the age 15-16 (Spangmose et al., 2019). We found no study investigate the impact of different embryo transfer strategies on the growth of children resulting from either fresh or frozen embryos.
In order to give strong recommendation on the efficacy and safety of fresh versus frozen embryo transfer, we conduct this study in order to investigate the physical and mental development of children from fresh versus frozen embryo transfer. Based on our Freeze-only study (Vuong et al., 2018), the women without polycystic ovary syndrome undergoing the first or second IVF were randomly assigned to receive either fresh or frozen embryos on day 3 after oocyte retrieval, which leads to the similarity in characteristics of these two groups. Hence, the result from analysing these offsprings would be preciously valuable.
- Conditions
- Infertility, IVF
- Being tested
- Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Physical development and General Health, Developmental Red flags
- Keywords
- Fresh transfer, freeze-only, 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.
Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3Other
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 HealthOther
Physical development and General health examination
Developmental Red flagsOther
Developmental Red flags Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Freeze-only | Children born from freeze-only group and frozen embryo transfer Receives: Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Other: Physical development and General Health; Other: Developmental Red flags | |
| Fresh | Children born from fresh embryo transfer Receives: Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3; Other: Physical development and General Health; Other: Developmental Red flags |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average total ASQ-3 score
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.
Measured: Up to 66 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 aspects in each stages has alternative threshold
Measured: Up to 66 months after birth
Score of Gross motor
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0.
Measured: Up to 66 months after birth
Score of Fine motor
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0.
Measured: Up to 66 months after birth
Score of Problem solving
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0.
Measured: Up to 66 months after birth
Score of Personal-Social
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0.
Measured: Up to 66 months after birth
The rate of children who have at least one red flag sign
He or she has at least one red flag sign by age
From 2 to < 3 year-old:
- Has very unclear speech
- Doesn't understand simple instruction • Doesn't speak in sentences
- Doesn't make eye contact
- Loses skills he/she once had
From 3 to < 4 year-old:
- Can't jump in place
- Doesn't play pretend or make-believe • Speaks unclearly
- Can't retell a favorite story
- Doesn't use "me" and "you" correctly
- Loses skills he/she once had
From 4 to < 5.5 year-old:
- Is easily distracted, has trouble focusing on one activity for more than 5 minutes • Doesn't talk about daily activities or experiences
- Shows extreme behavior
- Loses skills he/she once had
Measured: From 2 to 5.5 years after birth
Duration of breast-feeding
Duration of breast-feeding
Measured: Up to 24 months after birth
Infant age at which weaning starts
Infant age at which weaning starts
Measured: Up to 24 months after birth
Name of diseases that lead to hospital admission
Name of diseases that lead to hospital admission
Measured: Up to 66 months after birth
Number of hospital admission
Number of hospital admission
Measured: Up to 66 months after birth
Weight
Weight on the examination date
Measured: Through study completion, an average of 1.5 months
Height
Height on the examination date
Measured: Through study completion, an average of 1.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Sep 2019
- Primary completion15 Nov 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Other
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan N Vuong, MD, PhD, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099784
- Sponsor's protocol ID
- CS/BVMĐ/19/08
- Status last verified
- Nov 2019
- First submitted
- 14 Sep 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen ZJ, Shi Y, Sun Y, Zhang B, Liang X, Cao Y, Yang J, Liu J, Wei D, Weng N, Tian L, Hao C, Yang D, Zhou F, Shi J, Xu Y, Li J, Yan J, Qin Y, Zhao H, Zhang H, Legro RS. Fresh versus Frozen Embryos for Infertility in the Polycystic Ovary Syndrome. N Engl J Med. 2016 Aug 11;375(6):523-33. doi: 10.1056/NEJMoa1513873.
PubMed 27509101Shi Y, Sun Y, Hao C, Zhang H, Wei D, Zhang Y, Zhu Y, Deng X, Qi X, Li H, Ma X, Ren H, Wang Y, Zhang D, Wang B, Liu F, Wu Q, Wang Z, Bai H, Li Y, Zhou Y, Sun M, Liu H, Li J, Zhang L, Chen X, Zhang S, Sun X, Legro RS, Chen ZJ. Transfer of Fresh versus Frozen Embryos in Ovulatory Women. N Engl J Med. 2018 Jan 11;378(2):126-136. doi: 10.1056/NEJMoa1705334.
PubMed 29320646Vuong LN, Dang VQ, Ho TM, Huynh BG, Ha DT, Pham TD, Nguyen LK, Norman RJ, Mol BW. IVF Transfer of Fresh or Frozen Embryos in Women without Polycystic Ovaries. N Engl J Med. 2018 Jan 11;378(2):137-147. doi: 10.1056/NEJMoa1703768.
PubMed 29320655Wei D, Liu JY, Sun Y, Shi Y, Zhang B, Liu JQ, Tan J, Liang X, Cao Y, Wang Z, Qin Y, Zhao H, Zhou Y, Ren H, Hao G, Ling X, Zhao J, Zhang Y, Qi X, Zhang L, Deng X, Chen X, Zhu Y, Wang X, Tian LF, Lv Q, Ma X, Zhang H, Legro RS, Chen ZJ. Frozen versus fresh single blastocyst transfer in ovulatory women: a multicentre, randomised controlled trial. Lancet. 2019 Mar 30;393(10178):1310-1318. doi: 10.1016/S0140-6736(18)32843-5. Epub 2019 Feb 28.
PubMed 30827784Pelkonen S, Koivunen R, Gissler M, Nuojua-Huttunen S, Suikkari AM, Hyden-Granskog C, Martikainen H, Tiitinen A, Hartikainen AL. Perinatal outcome of children born after frozen and fresh embryo transfer: the Finnish cohort study 1995-2006. Hum Reprod. 2010 Apr;25(4):914-23. doi: 10.1093/humrep/dep477. Epub 2010 Feb 2.
PubMed 20124395Spangmose AL, Malchau SS, Henningsen AA, Forman JL, Rasmussen S, Loft A, Schmidt L, Pinborg A. Academic performance in adolescents aged 15-16 years born after frozen embryo transfer compared with fresh embryo transfer: a nationwide registry-based cohort study. BJOG. 2019 Jan;126(2):261-269. doi: 10.1111/1471-0528.15484. Epub 2018 Oct 24.
PubMed 30276983Vuong LN, Ly TT, Nguyen NA, Nguyen LMT, Le XTH, Le TK, Le KTQ, Le TV, Nguyen MHN, Dang VQ, Norman RJ, Mol BW, Ho TM. Development of children born from freeze-only versus fresh embryo transfer: follow-up of a randomized controlled trial. Fertil Steril. 2020 Sep;114(3):558-566. doi: 10.1016/j.fertnstert.2020.04.041. Epub 2020 Jun 16.
PubMed 32560970
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Children Born From Freeze-only Versus Fresh Embryo Transfer: a Follow-up of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04099784
- Acronym / sponsor ID
- CS/BVMĐ/19/08
- Conditions
- Infertility, IVF
- Keywords
- Fresh transfer, freeze-only, ASQ-3, health of children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 23 Sep 2019 (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.
In order to give strong recommendation on the efficacy and safety of fresh versus frozen embryo transfer, we conduct this study in order to investigate the physical and mental development of children from fresh versus frozen embryo transfer. Based on our Freeze-only study (Vuong et al., 2018), the women without polycystic ovary syndrome undergoing the first or second IVF were randomly assigned to receive either fresh or frozen embryos on day 3 after oocyte retrieval, which leads to the similarity in characteristics of these two groups. Hence, the result from analysing these offsprings would be preciously valuable.
Detailed description
Since the first live birth after the transfer of a frozen-thawed embryo reported in 1984, cryopreservation has been considered as an enormous revolution in assisted reproductive technology (ART). It is observed that the trend of ART cycles using frozen embryo transfer is on the increase, which leads to a great deal number of children born from frozen embryos. This is the commencement of 2 embryo transfer strategies, the first one is transferring the fresh embryos, the other is freezing all the embryos and transfer them in the next cycle.
Comparing these two strategies, up till now, there are 4 published randomized control trials (RCTs) indicating different methods for certain groups of patients (Chen et al., 2016; Shi et al., 2018; Vuong et al., 2018; Wei et al., 2019). Regarding the efficacy, the freeze-all strategy outweighs the fresh embryo transfer in women with polycystic ovary syndrome (PCOS). While that efficacy gets a controversy in non-PCOS or ovulatory patients; two groups of authors indicated that these 2 strategies are equally effective, while the other group claims that the better result goes to cycles with frozen embryos. In term of safety, the rate of ovarian hyperstimulation syndrome (OHSS) is the equivalent or lower in the freeze-all group, which implies the important role of embryo-freezing in avoiding maternal risk. The question that whether freezing the embryos exerts effect on offspring is not thoroughly understood. The mostly used parameter in evaluating the safety of children is the perinatal status of infants, not the development of these children.
Searching literature, in 2010, S. Pelkonen published a large cohort study indicating that freezing the embryos do not change the rate of prematurity, low birthweight and being small for gestational age (Pelkonen et al., 2010). Looking further in our freeze-only study, our sub-analysis indicates that the livebirth weight of infants born from frozen embryos is 300 gram heavier than that from fresh embryos (Vuong et al., 2018). Following 4 studies comparing fresh and frozen embryo transfer, children from frozen embryos are similar or higher in term of newborn weight, and there is no study investigate the onward development of childrens born from these two strategies. The only proof on the development of children born from fresh verus frozen embryo is from one study with no randomization which states that children from fresh and frozen embryos share similar academic performance at the age 15-16 (Spangmose et al., 2019). We found no study investigate the impact of different embryo transfer strategies on the growth of children resulting from either fresh or frozen embryos.
In order to give strong recommendation on the efficacy and safety of fresh versus frozen embryo transfer, we conduct this study in order to investigate the physical and mental development of children from fresh versus frozen embryo transfer. Based on our Freeze-only study (Vuong et al., 2018), the women without polycystic ovary syndrome undergoing the first or second IVF were randomly assigned to receive either fresh or frozen embryos on day 3 after oocyte retrieval, which leads to the similarity in characteristics of these two groups. Hence, the result from analysing these offsprings would be preciously valuable.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freeze-only | – | Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Other: Physical development and General Health, Other: Developmental Red flagsChildren born from freeze-only group and frozen embryo transfer |
| Fresh | – | Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Other: Physical development and General Health, Other: Developmental Red flagsChildren born from fresh embryo transfer |
Who may qualify
- Ages
- 1 month to 66 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Live babies born following the frozen embryo transfer and fresh embryo transfer from our Freeze-only study (NCT02471573)
Key inclusion criteria (2 listed)
- Live babies born from the first transfer of both freeze-only and fresh embryo transfer group from our Freeze-only study.
- Parents agree to participate in the study.
Key exclusion criteria (1 listed)
- Babies died after perinatal period.
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 |
|---|---|---|
| Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3Ages \& 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 | Freeze-only, Fresh |
| Physical development and General HealthPhysical development and General health examination | Other | Freeze-only, Fresh |
| Developmental Red flagsDevelopmental Red flags Questionnaires | Other | Freeze-only, Fresh |
Primary outcome
The average total ASQ-3 score
Time frame: Up to 66 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.
12 secondary outcomes
Score of Communication
Time frame: Up to 66 months after birth
Score of Gross motor
Time frame: Up to 66 months after birth
Score of Fine motor
Time frame: Up to 66 months after birth
Score of Problem solving
Time frame: Up to 66 months after birth
Score of Personal-Social
Time frame: Up to 66 months after birth
The rate of children who have at least one red flag sign
Time frame: From 2 to 5.5 years after birth
Duration of breast-feeding
Time frame: Up to 24 months after birth
Infant age at which weaning starts
Time frame: Up to 24 months after birth
Name of diseases that lead to hospital admission
Time frame: Up to 66 months after birth
Number of hospital admission
Time frame: Up to 66 months after birth
Weight
Time frame: Through study completion, an average of 1.5 months
Height
Time frame: Through study completion, an average of 1.5 months
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 3 Mar 2020.
- Background: PubMed 27509101Chen ZJ, Shi Y, Sun Y, Zhang B, Liang X, Cao Y, Yang J, Liu J, Wei D, Weng N, Tian L, Hao C, Yang D, Zhou F, Shi J, Xu Y, Li J, Yan J, Qin Y, Zhao H, Zhang H, Legro RS. Fresh versus Frozen Embryos for Infertility in the Polycystic Ovary Syndrome. N Engl J Med. 2016 Aug 11;375(6):523-33. doi: 10.1056/NEJMoa1513873.
- Background: PubMed 29320646Shi Y, Sun Y, Hao C, Zhang H, Wei D, Zhang Y, Zhu Y, Deng X, Qi X, Li H, Ma X, Ren H, Wang Y, Zhang D, Wang B, Liu F, Wu Q, Wang Z, Bai H, Li Y, Zhou Y, Sun M, Liu H, Li J, Zhang L, Chen X, Zhang S, Sun X, Legro RS, Chen ZJ. Transfer of Fresh versus Frozen Embryos in Ovulatory Women. N Engl J Med. 2018 Jan 11;378(2):126-136. doi: 10.1056/NEJMoa1705334.
- Background: PubMed 29320655Vuong LN, Dang VQ, Ho TM, Huynh BG, Ha DT, Pham TD, Nguyen LK, Norman RJ, Mol BW. IVF Transfer of Fresh or Frozen Embryos in Women without Polycystic Ovaries. N Engl J Med. 2018 Jan 11;378(2):137-147. doi: 10.1056/NEJMoa1703768.
- Background: PubMed 30827784Wei D, Liu JY, Sun Y, Shi Y, Zhang B, Liu JQ, Tan J, Liang X, Cao Y, Wang Z, Qin Y, Zhao H, Zhou Y, Ren H, Hao G, Ling X, Zhao J, Zhang Y, Qi X, Zhang L, Deng X, Chen X, Zhu Y, Wang X, Tian LF, Lv Q, Ma X, Zhang H, Legro RS, Chen ZJ. Frozen versus fresh single blastocyst transfer in ovulatory women: a multicentre, randomised controlled trial. Lancet. 2019 Mar 30;393(10178):1310-1318. doi: 10.1016/S0140-6736(18)32843-5. Epub 2019 Feb 28.
- Background: PubMed 20124395Pelkonen S, Koivunen R, Gissler M, Nuojua-Huttunen S, Suikkari AM, Hyden-Granskog C, Martikainen H, Tiitinen A, Hartikainen AL. Perinatal outcome of children born after frozen and fresh embryo transfer: the Finnish cohort study 1995-2006. Hum Reprod. 2010 Apr;25(4):914-23. doi: 10.1093/humrep/dep477. Epub 2010 Feb 2.
- Background: PubMed 30276983Spangmose AL, Malchau SS, Henningsen AA, Forman JL, Rasmussen S, Loft A, Schmidt L, Pinborg A. Academic performance in adolescents aged 15-16 years born after frozen embryo transfer compared with fresh embryo transfer: a nationwide registry-based cohort study. BJOG. 2019 Jan;126(2):261-269. doi: 10.1111/1471-0528.15484. Epub 2018 Oct 24.
- Derived from this study: PubMed 32560970Vuong LN, Ly TT, Nguyen NA, Nguyen LMT, Le XTH, Le TK, Le KTQ, Le TV, Nguyen MHN, Dang VQ, Norman RJ, Mol BW, Ho TM. Development of children born from freeze-only versus fresh embryo transfer: follow-up of a randomized controlled trial. Fertil Steril. 2020 Sep;114(3):558-566. doi: 10.1016/j.fertnstert.2020.04.041. Epub 2020 Jun 16.
- Individual participant dataSharing planned: Undecided
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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 N Vuong, MD, 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 IVF, 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 2 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 3 Mar 2020. 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 average total ASQ-3 score (time frame: Up to 66 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 NCT04099784, which also lists 7 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 3 Mar 2020.