IVFONESTEPNCT07088640
Single Step Protocol and Multi-step Warming Protocol for Blastocyst FET
A study testing Single-step warming protocol by thawing solution only and Standard warming protocol in people with IVF and Frozen Embryo Transfer (FET), run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
The multi-step thawing protocol with a reduction of non-permeable cryoprotectant concentrations to reduce osmotic shock caused by the rapid influx of water. Recent studies have shown that a simplified warming protocol by only a thawing solution gave a comparable survival rate but increased pregnancy rate, reduced… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- IVF, Frozen Embryo Transfer (FET), Embryo Thawing Protocol
- What is being tested?
- Single-step warming protocol by thawing solution only and Standard warming protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 816 participants
- Where
- 1 siteVietnam
- Study dates
- 13 Aug 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged from 18
- Undergoing no more than 3 previous IVF/ICSI cycles
- Had at least a single good-quality blastocyst frozen.
- Endometrium preparation using artificial cycle
- Agree to single blastocyst transfer
- Not participating in any interventional studies at the same time
Who cannot join
- Embryos from cycles after in-vitro maturation, pre-implantation genetic testing (PGT)
- Having contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease)
- Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx or endometrial polyp)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
My Duc Hospital
Ho Chi Minh City, City, 7000
Tuong M Ho, MSc, MD, +84 90 3633377, tuongho.ivfmd@gmail.com
About this study
Official title: The Live Birth Rate Between Single and Multi-step Warming Protocol Applied in Blastocyst Vitrification: a Randomized Controlled Trial
The multi-step thawing protocol with a reduction of non-permeable cryoprotectant concentrations to reduce osmotic shock caused by the rapid influx of water. Recent studies have shown that a simplified warming protocol by only a thawing solution gave a comparable survival rate but increased pregnancy rate, reduced patients' waiting time, and decreased the workload of embryologists.
Read the detailed description
Nowadays, vitrification is the gold standard method in freezing human embryos, using different commercial brands of ready-to-use kits. Removing cytotoxic cryoprotectants and rehydration to prevent osmotic shock has been a fundamental principle in cryobiology. This minimized damage during the vitrification/thawing (V/T) process. However, the entire process is time-consuming and labor-intensive in the IVF laboratory. Especially, some laboratories have difficulty ordering the same brand of medium for V/T kits. Because of the long period of cryopreserved embryos, it may be that embryos were vitrified and warmed with different kits with a potentially different kind and concentrations of cryoprotective agents. Recently, the combinations of the two different V/T commercial kits have shown comparable survival, blastulation, and implantation rates in both own and donor oocyte cycles.
Additionally, there remains an opportunity and a necessity to continue improving the warming protocol. The key factors for thawing require a fast warming rate, a gradually decreasing concentration of intracellular cryoprotectant, and embryologist skills to secure the survival rate.
Based on previous work, one option would be shortening the time necessary to rehydrate. A study by Seki and Mazur has shown that embryo survival is almost entirely dependent on the warming rate rather than the extracellular cryoprotectant concentration used. A recent study by Liebermann showed that simplifying warming procedures in one step by using 1M sucrose only is possible with an encouragingly higher ongoing pregnancy rate and comparable clinical outcomes when compared to the same conventional multi-step warming protocol, showing a significantly lower miscarriage rate (4.0% vs. 7.6%). These results lead to a faster, safer, and more cost-effective procedure.
This study aims to investigate the effectiveness and safety of a new combination of V/W solutions-single and multi-step thawing protocol- on live birth rate (LBR), as well as embryo transfer, obstetric, and neonatal outcomes.
- Conditions
- IVF, Frozen Embryo Transfer (FET), Embryo Thawing Protocol
- Being tested
- Single-step warming protocol by thawing solution only, Standard warming protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-step warming protocol by thawing solution onlyProcedure or surgery
Also called Single-step thawing protocol
Potentially eligible patients' vitrified blastocysts will be thawed by a single-step thawing protocol. For the warming phase, vitrified blastocysts are exposed to the thawing solution of a commercial embryo thawing kit (Irvine Scientific Inc., USA) at 37°C for one minute. Immediately following this, embryos will be rinsed in a 35mm diameter dish of 2ml of pre-equilibrated thawing solution before being placed in culture media in the incubator for at least 2 hours before transfer.
Standard warming protocolProcedure or surgery
Also called Multi-step warming protocol
For the MS protocol, thawing kits were equilibrated overnight in a 37°C incubator. Warming procedures utilized the kits (Cryotech RtU, Japan). To remove the cryoprotectants, blastocysts were warmed, and cryoprotectants were diluted in a three-step process.
The warming process starts with the exposure of blastocysts to thaw solution (TS) with 1M trehalose for one minute at 37°C. Subsequently, the blastocyst will be transferred to a second well containing a dilution solution (DS) of 0.5M trehalose for a two-minute rinse at room temperature. This is followed by two additional three-minute and 30-second rinses in the wash solution (WS) at room temperature. The timeline for standard warming of blastocysts requires a total of 6.5 min. After thawing, embryo will be placed in the incubator at least 2 hours before transfer.
| Study group | Role | What they receive |
|---|---|---|
| Single-step thawing protocol | Experimental | For the warming phase, vitrified blastocysts are exposed to the thawing solution of a commercial embryo thawing kit (Irvine Scientific Inc., USA) at 37°C for one minute. Immediately following this, embryos will be rinsed through a 35mm diameter dish of 2ml of pre-equilibrated thawing solution before being placed in culture media in the incubator for at least 2 hours before transfer. Receives: Procedure: Single-step warming protocol by thawing solution only |
| Multi-step thawing protocol | Experimental | For the Multi-step (MS) protocol, thawing kits were equilibrated overnight in a 37°C incubator. Warming procedures utilized the kits (Cryotech RtU, Japan). To remove the cryoprotectants, blastocysts were warmed, and cryoprotectants were diluted in a three-step process.
The warming process starts with the exposure of blastocysts to thaw solution (TS) with 1M trehalose for one minute, set at a temperature to ensure 37°C. Subsequently, blastocysts will be transferred to a second well containing dilution solution (DS) 0.5M trehalose for a two-minute rinse at room temperature. This is followed by two additional three-minute and 30 seconds rinses in the wash solution (WS) at room temperature. The timeline for standard warming of blastocysts requires a total of 6.5 min. After thawing, embryo will be placed in the incubator at least 2 hours before transfer. Receives: Procedure: Standard warming protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown
Measured: At 22 weeks of gestation
Secondary outcomes (20)
Survival rate
The survival rate by the presence of blastocoel re-expansion before embryo transfer.
Measured: At least 2 hours after thawing.
Cancellation rate
Cancellation due to: The blastocyst cells are lysed after thawing.
Measured: Any day during endometrium preparation days before embryo transfer.
Positive pregnancy test
Serum ß-hCG ≥25mIU/mL
Measured: At 2 weeks after embryo placement
Implantation rate
The implantation rate is explained as the number of gestational sacs per number of embryos transferred
Measured: At 3 weeks after embryo placement
Clinical pregnancy
diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy at 6 weeks or more after the onset of the last menstrual period. In addition to intra-uterine pregnancy, it includes a clinically documented ectopic pregnancy.
Measured: At 5 weeks after embryo placement
Ectopic pregnancy
A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualisation, or histopathology
Measured: At 7 weeks of gestation
Ongoing pregnancy
Having at least one gestational sac on ultrasound at 12 weeks' gestation with heart beat activity
Measured: At 10 weeks after embryo placement
Miscarriage
The spontaneous loss of an intra-uterine pregnancy before 22 completed weeks of gestational age
Measured: before 22 completed weeks of gestational age
Preterm delivery
Multiple definitions, defined as delivery at <24, <28, <32, <37 completed weeks
Measured: At 22, 28, 32 weeks and 37 weeks of gestation
Major congenital abnormalities
Structural or functional disorders that occur during intra-uterine life and can be identified prenatally, at birth or later in life. Congenital anomalies can be caused by single gene defects, chromosomal disorders, multifactorial inheritance, environmental teratogens and micronutrient deficiencies. The time of identification should be reported. Any congenital anomaly will be included as followed definition of congenital abnormalities in Surveillance of Congenital Anomalies by Division of Birth Defects and Developmental Disabilities, NCBDDD, Centers for Disease Control and Prevention (2020).
Measured: At birth
Birth weight
Weight of singletons and twins
Measured: At the time of delivery
Low birth weight
Weight < 2500 gm at birth
Measured: At the time of delivery
Very low birth weight
Weight < 1500 gm at birth
Measured: At the time of delivery
High birth weight
Weight over than 4.500 g for women with diabetes, and a threshold of 5.000 g for women without diabetes
Measured: At the time of delivery
Admission to NICU
The admittance of the newborn to NICU
Measured: At birth
Multiple pregnancy
≥2 gestational sac at early pregnancy ultrasound
Measured: At 6 to 8 weeks' gestation
Multiple delivery
Birth of more than one baby beyond 22 weeks
Measured: At 22 weeks' gestation
Still birth
The death of a fetus prior to the complete expulsion or extraction from its mother after 20 completed weeks of gestational age. The death is determined by the fact that, after such separation, the fetus does not breathe or show any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles.
Measured: At 20 weeks' gestation
Neonatal mortality
Death of a live-born baby within 28 days of birth. This can be divided into early neonatal mortality, if death occurs in the first seven days after birth, and late neonatal if death occurs between eight and 28 days after delivery
Measured: within 28 days of birth
Direct costs to live birth
Total direct cost to have a live birth after embryo transfer. Direct cost include medical consultations, ovulation stimulation drugs, laboratory and embryology services, ultrasound scanning, medical procedures such as oocyte retrieval and embryo transfer, hospital charges, nursing and counselling services and administrative and overhead charges. Cost data will be collected for a supplementary analysis and will be reported in a separated paper.
Measured: At the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start13 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IVFStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 816 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan TN Vuong, MD, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088640
- Sponsor's protocol ID
- 07/25/DD-BVMD
- Acronym
- ONESTEP
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Connolly MP, Hoorens S, Chambers GM; ESHRE Reproduction and Society Task Force. The costs and consequences of assisted reproductive technology: an economic perspective. Hum Reprod Update. 2010 Nov-Dec;16(6):603-13. doi: 10.1093/humupd/dmq013. Epub 2010 Jun 8.
PubMed 20530804Seki S, Mazur P. The dominance of warming rate over cooling rate in the survival of mouse oocytes subjected to a vitrification procedure. Cryobiology. 2009 Aug;59(1):75-82. doi: 10.1016/j.cryobiol.2009.04.012. Epub 2009 May 7.
PubMed 19427303Gallardo M, Saenz J, Risco R. Human oocytes and zygotes are ready for ultra-fast vitrification after 2 minutes of exposure to standard CPA solutions. Sci Rep. 2019 Nov 5;9(1):15986. doi: 10.1038/s41598-019-52014-x.
PubMed 31690725
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Live Birth Rate Between Single and Multi-step Warming Protocol Applied in Blastocyst Vitrification: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07088640
- Acronym / sponsor ID
- ONESTEP / 07/25/DD-BVMD
- Conditions
- IVF, Frozen Embryo Transfer (FET), Embryo Thawing Protocol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 816 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Jul 2025 (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 multi-step thawing protocol with a reduction of non-permeable cryoprotectant concentrations to reduce osmotic shock caused by the rapid influx of water. Recent studies have shown that a simplified warming protocol by only a thawing solution gave a comparable survival rate but increased pregnancy rate, reduced patients' waiting time, and decreased the workload of embryologists.
Detailed description
Nowadays, vitrification is the gold standard method in freezing human embryos, using different commercial brands of ready-to-use kits. Removing cytotoxic cryoprotectants and rehydration to prevent osmotic shock has been a fundamental principle in cryobiology. This minimized damage during the vitrification/thawing (V/T) process. However, the entire process is time-consuming and labor-intensive in the IVF laboratory. Especially, some laboratories have difficulty ordering the same brand of medium for V/T kits. Because of the long period of cryopreserved embryos, it may be that embryos were vitrified and warmed with different kits with a potentially different kind and concentrations of cryoprotective agents. Recently, the combinations of the two different V/T commercial kits have shown comparable survival, blastulation, and implantation rates in both own and donor oocyte cycles.
Additionally, there remains an opportunity and a necessity to continue improving the warming protocol. The key factors for thawing require a fast warming rate, a gradually decreasing concentration of intracellular cryoprotectant, and embryologist skills to secure the survival rate.
Based on previous work, one option would be shortening the time necessary to rehydrate. A study by Seki and Mazur has shown that embryo survival is almost entirely dependent on the warming rate rather than the extracellular cryoprotectant concentration used. A recent study by Liebermann showed that simplifying warming procedures in one step by using 1M sucrose only is possible with an encouragingly higher ongoing pregnancy rate and comparable clinical outcomes when compared to the same conventional multi-step warming protocol, showing a significantly lower miscarriage rate (4.0% vs. 7.6%). These results lead to a faster, safer, and more cost-effective procedure.
This study aims to investigate the effectiveness and safety of a new combination of V/W solutions-single and multi-step thawing protocol- on live birth rate (LBR), as well as embryo transfer, obstetric, and neonatal outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-step thawing protocol | Experimental | Procedure: Single-step warming protocol by thawing solution onlyFor the warming phase, vitrified blastocysts are exposed to the thawing solution of a commercial embryo thawing kit (Irvine Scientific Inc., USA) at 37°C for one minute. Immediately following this, embryos will be rinsed through a 35mm diameter dish of 2ml of pre-equilibrated thawing solution before being placed in culture media in the incubator for at least 2 hours before transfer. |
| Multi-step thawing protocol | Experimental | Procedure: Standard warming protocolFor the Multi-step (MS) protocol, thawing kits were equilibrated overnight in a 37°C incubator. Warming procedures utilized the kits (Cryotech RtU, Japan). To remove the cryoprotectants, blastocysts were warmed, and cryoprotectants were diluted in a three-step process. The warming process starts with the exposure of blastocysts to thaw solution (TS) with 1M trehalose for one minute, set at a temperature to ensure 37°C. Subsequently, blastocysts will be transferred to a second well containing dilution solution (DS) 0.5M trehalose for a two-minute rinse at room temperature. This is followed by two additional three-minute and 30 seconds rinses in the wash solution (WS) at room temperature. The timeline for standard warming of blastocysts requires a total of 6.5 min. After thawing, embryo will be placed in the incubator at least 2 hours before transfer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged from 18
- Undergoing no more than 3 previous IVF/ICSI cycles
- Had at least a single good-quality blastocyst frozen.
- Endometrium preparation using artificial cycle
- Agree to single blastocyst transfer
Key exclusion criteria (3 listed)
- Embryos from cycles after in-vitro maturation, pre-implantation genetic testing (PGT)
- Having contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease)
- Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx or endometrial polyp)
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 |
|---|---|---|
| Single-step warming protocol by thawing solution onlyAlso: Single-step thawing protocolPotentially eligible patients' vitrified blastocysts will be thawed by a single-step thawing protocol. For the warming phase, vitrified blastocysts are exposed to the thawing solution of a commercial embryo thawing kit (Irvine Scientific Inc., USA) at 37°C for one minute. Immediately following this, embryos will be rinsed in a 35mm diameter dish of 2ml of pre-equilibrated thawing solution before being placed in culture media in the incubator for at least 2 hours before transfer. | Procedure or surgery | Single-step thawing protocol |
| Standard warming protocolAlso: Multi-step warming protocolFor the MS protocol, thawing kits were equilibrated overnight in a 37°C incubator. Warming procedures utilized the kits (Cryotech RtU, Japan). To remove the cryoprotectants, blastocysts were warmed, and cryoprotectants were diluted in a three-step process. The warming process starts with the exposure of blastocysts to thaw solution (TS) with 1M trehalose for one minute at 37°C. Subsequently, the blastocyst will be transferred to a second well containing a dilution solution (DS) of 0.5M trehalose for a two-minute rinse at room temperature. This is followed by two additional three-minute and 30-second rinses in the wash solution (WS) at room temperature. The timeline for standard warming of blastocysts requires a total of 6.5 min. After thawing, embryo will be placed in the incubator at least 2 hours before transfer. | Procedure or surgery | Multi-step thawing protocol |
Primary outcome
Live birth rate
Time frame: At 22 weeks of gestation
Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown
20 secondary outcomes
Survival rate
Time frame: At least 2 hours after thawing.
Cancellation rate
Time frame: Any day during endometrium preparation days before embryo transfer.
Positive pregnancy test
Time frame: At 2 weeks after embryo placement
Implantation rate
Time frame: At 3 weeks after embryo placement
Clinical pregnancy
Time frame: At 5 weeks after embryo placement
Ectopic pregnancy
Time frame: At 7 weeks of gestation
Ongoing pregnancy
Time frame: At 10 weeks after embryo placement
Miscarriage
Time frame: before 22 completed weeks of gestational age
Preterm delivery
Time frame: At 22, 28, 32 weeks and 37 weeks of gestation
Major congenital abnormalities
Time frame: At birth
Birth weight
Time frame: At the time of delivery
Low birth weight
Time frame: At the time of delivery
Very low birth weight
Time frame: At the time of delivery
High birth weight
Time frame: At the time of delivery
Admission to NICU
Time frame: At birth
Multiple pregnancy
Time frame: At 6 to 8 weeks' gestation
Multiple delivery
Time frame: At 22 weeks' gestation
Still birth
Time frame: At 20 weeks' gestation
Neonatal mortality
Time frame: within 28 days of birth
Direct costs to live birth
Time frame: At the time of delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 20530804Connolly MP, Hoorens S, Chambers GM; ESHRE Reproduction and Society Task Force. The costs and consequences of assisted reproductive technology: an economic perspective. Hum Reprod Update. 2010 Nov-Dec;16(6):603-13. doi: 10.1093/humupd/dmq013. Epub 2010 Jun 8.
- Results publication: PubMed 19427303Seki S, Mazur P. The dominance of warming rate over cooling rate in the survival of mouse oocytes subjected to a vitrification procedure. Cryobiology. 2009 Aug;59(1):75-82. doi: 10.1016/j.cryobiol.2009.04.012. Epub 2009 May 7.
- Results publication: PubMed 31690725Gallardo M, Saenz J, Risco R. Human oocytes and zygotes are ready for ultra-fast vitrification after 2 minutes of exposure to standard CPA solutions. Sci Rep. 2019 Nov 5;9(1):15986. doi: 10.1038/s41598-019-52014-x.
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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.
Lan TN Vuong, MD, PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-step warming protocol by thawing solution only and Standard warming protocol in people with IVF and Frozen Embryo Transfer (FET), 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tam TM Luu, MD (+84357426024, tam.ltm@myduchospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: At 22 weeks of gestation). 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 NCT07088640, which also lists 3 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 12 Sep 2025.