in Vitro FertilizationNCT05402605
AOA Versus Non-AOA in Low Prognosis Patients by the POSEIDON Criteria
A study testing ICSI with AOA and ICSI without AOA in people with in Vitro Fertilization, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
Poor ovarian response (POR) remains one of the significant challenges of Assisted Reproductive Technology (ART). Facing difficulties related to clinical practice, optimizing the embryo culture process is necessary to improve the embryo number and quality in this group of patients. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- in Vitro Fertilization
- What is being tested?
- ICSI with AOA and ICSI without AOA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteVietnam
- Study dates
- 29 Aug 2022to 30 Jun 2024
- Phase
- Interventional
- 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 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Was diagnosed as low prognosis patients by the POSEIDON criteria in group 4: maternal age ≥ 35 years old, AMH < 1,2 ng/ml and AFC < 5
- Cycles ≤ 3
- Oocytes could be collected with OPU procedure
- Ovarian stimulation with GnRH antagonist protocol
- Agree to participate in the randomization
Who cannot join
- Uterine abnormalities such as unicornuate, bicornuate uterus, didelphys and adenomyosis
- Recent history of any current untreated endocrine abnormality
- Gonadotropin resistance syndrome
- Contraindications of gonadotropins
- Absolute asthernozoospermia
- Cryptozoospermia
Show all 11Show fewer
- Surgical sperm retrieval
- Previous low fertilization (< 30%)
- Globozoospermia
- Cycles using donor oocytes
- Preimplantation Genetic Testing (PGT) cycles
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
IVFMD, My Duc Hospital
Ho Chi Minh City
Tuong M Ho, M.D, +84903633377, tuongho.ivfmd@gmail.com
Kha T Huynh, MSc, +84946699470, kha.ht@myduchospital.vn
About this study
Official title: The Effectiveness and Safety of Artificial Oocyte Activation With Calcium Ionophore in Low Prognosis Women Classified as POSEIDON Group 4: a Randomized Clinical Trial
Poor ovarian response (POR) remains one of the significant challenges of Assisted Reproductive Technology (ART). Facing difficulties related to clinical practice, optimizing the embryo culture process is necessary to improve the embryo number and quality in this group of patients. Potential techniques mentioned in the current literature include follicular size at trigger, dual trigger, artificial oocyte activation (AOA), blastocyst transfer, and the role of preimplantation genetic testing for aneuploidy (PGT-A). AOA is currently expected to improve treatment outcomes in poor ovarian responders with the potential for clinical efficacy. However, this issue has not been evaluated before.
Read the detailed description
Poor ovarian response (POR) remains one of the significant challenges of Assisted Reproductive Technology (ART). Patients with POR yield a low number of oocytes, leading to a low number of useable embryos and a decline in the live birth rate. According to the consensus of the European Society of Human Reproduction and Embryology (ESHRE) in 2011, POR was diagnosed using Bologna criteria. However, some recent studies show the classification by Bologna is not efficient, because the oocyte number should be combined with female age since the likelihood of achieving a live birth among patients with similar oocyte yield ultimately depends on the age of the patient. In 2016, POSEIDON (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number) Group was established and released the new criteria. The POSEIDON criteria proposed a shift from the terminology of POR to the concept of low prognosis. According to POSEIDON criteria, low prognosis account for 30-40% of all stimulated in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles. The low prognosis patient is classified into four groups according to the results of ovarian reserve markers (AMH, AFC, or both), female age, and the number of oocytes retrieved in previous cycles, such as: maternal age < 35, AMH ≥ 1,2 ng/ml and AFC ≥ 5 (subgroup 1a: < 4 oocytes; subgroup 1b: 4-9 oocytes); maternal age ≥ 35, AMH ≥ 1,2 ng/ml and AFC ≥ 5 (subgroup 2a: < 4 oocytes; subgroup 2b: 4-9 oocytes); maternal age < 35, AMH < 1,2 ng/ml and AFC < 5; maternal age ≥ 35, AMH < 1,2 ng/mL and AFC < 5. Although many efforts have been made to improve treatment outcomes in this group of patients, such as researching, understanding, and modifying clinical ovarian stimulation regimens, the results are still not feasible. Especially, group 4, which have advanced maternal age (≥ 35) and seized for 14.4% of low prognosis, has a low cumulative live birth rate (11% in group 4). Female age is a critical element in the POSEIDON classification because age is crucially related to embryo ploidy and more importantly live birth outcome. The probability of having embryo ploidy sharply declined after the age of 34 and was lower than 50% in women aged 35 years and over. Therefore, patients in group 4 will have an increased risk of aneuploidy embryos, decreasing the live birth rate in these groups of patients. A recent study evaluated cumulative live birth rates per cycle, there was a remarkable difference between POSEIDON patients (21, 43, 10, 25, 29, and 17% in groups 1a, 1b, 2a, 2b, 3, and 4, respectively) and non-POSEIDON counterparts (52%). Facing difficulties related to clinical practice, optimizing the embryo culture process is necessary to improve the embryo number and quality in the POR group. Potential techniques include follicular size at the trigger, dual trigger, artificial oocyte activation (AOA), blastocyst transfer, and the role of preimplantation genetic testing for aneuploidy (PGT-A).
In Vietnam, AOA was first reported in 2011, performing on 1588 oocytes, and said the fertilization rate was higher in the ICSI - AOA than in the ICSI group (80.8% vs 74.3%, respectively; p<0.002).
AOA is expected to improve treatment outcomes for low prognosis patients, especially in group 4 by the POSEIDON criteria with the potential for clinical efficacy and safety. Therefore, this study aims to evaluate the effectiveness and safety of AOA on treatment outcomes in low prognosis patients defined by the POSEIDON criteria (2016).
- Conditions
- in Vitro Fertilization
- Being tested
- ICSI with AOA, ICSI without AOA
- Keywords
- POSEIDON, in vitro fertilization, live birth, low prognosis, AOA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICSI with AOAProcedure or surgery
Step 1: All post-ICSI oocytes will be added in the medium drop in AOA dish, these oocytes will be placed in the incubator at 37oC, 6% CO2, and 5% O2 for 20 minutes.
Step 2: After 20 minutes, calcium ionophore stock (Sigma-Aldrich - USA) will be diluted into 10µM drops in AOA dish.
Step 3: After 10 minutes of incubation, all post-ICSI oocytes will be moved to the AOA drop, then this dish will be put back in the incubator for 10 minutes.
Step 4: After 10 minutes, all the oocytes in drop AOA will be moved to another drop for rinsing and then put back in the incubator for 20 minutes.
Step 5: After 20 minutes, the oocytes will be moved into drop AOA and then put back in the incubator for 10 minutes.
Step 6: After 10 minutes, all post-ICSI oocytes will be added in the medium drop, then divided into drops with maximum 3 oocytes per drop for culturing. After that, the culture dish will be put in the K-system G185 incubator at 37oC, 6% CO2, and 5% O2
ICSI without AOAProcedure or surgery
Conventional ICSI procedure will be performed without the application of AOA.
| Study group | Role | What they receive |
|---|---|---|
| ICSI with AOA | Active comparator | The oocytes were transferred into the calcium ionophore activation solution for two times of post-ICSI AOA (Ionomycin concentration of 10 µM).
Then the oocytes will be washed several times using the medium drops in dish AOA and dish ICSI, then divided into drops with maximum 3 oocytes per drop for culturing. After that, the culture dish will be put in the K-system G185 incubator at 37oC, 6% CO2, and 5% O2. Receives: Procedure: ICSI with AOA |
| ICSI without AOA | Active comparator | Post-ICSI oocytes will be cultured in drops containing the Sage - 1 - StepSM medium (maximum 3 oocytes per drop) at 37oC, 6% CO2 and 5% O2 in K-system G185 incubator. Receives: Procedure: ICSI without AOA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
The complete expulsion or extraction from a woman of a product of fertilisation, after 24 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 350 grams or more can be used if gestational age is unknown (twins are a single count).
Measured: At 24 weeks of gestation
Secondary outcomes (38)
Fertilization rate
The percentage of transformation of micro injected oocytes into two pronuclei
Measured: One day after oocyte retrieval
Fertilization failure rate
The percentage transformation of micro injected oocytes into no pronuclei
Measured: One day after oocyte retrieval
Abnormal fertilization rate
The percentage transformation of micro injected oocytes into more than two pronuclei
Measured: One day after oocyte retrieval
Total embryos on day 3
Number of embryos on day 3
Measured: Three days after oocyte retrieval
Good quality day 3 embryo rate
Number of good quality embryos on day 3
Measured: Three days after oocyte retrieval
Total embryos blastocyst
Number of embryos on day 5
Measured: Five days after oocyte retrieval
Good quality blastocyst rate
Number of good quality embryos on day 5
Measured: Five days after oocyte retrieval
Positive pregnancy test
Serum ß-hCG ≥25mIU/mL
Measured: At 2 weeks after embryo placement
Implantation rate
Implantation rate is explained as as the number of gestational sacs per number of embryos transferred.
Measured: At 3 weeks after embryo placement
Cumulative implantation rate at 12 months
After 12 months, most patients doing IVF have finished all their frozen embryos; therefore, we consider this time point for analyzing the cumulative implantation rate.
Cumulative implantation is total case of gestational sacs per total patient to be enrolled into the study at 12 months after randomization
Measured: 12 months after randomization
Clinical pregnancy
Having at least 1 gestational sac on ultrasound at 5 weeks' gestation
Measured: At 7 weeks after embryo placement]
Cumulative clinical pregnancy at 12 months
After 12 months, most patients doing IVF have finished all their frozen embryos; therefore, we consider this time point for analyzing the cumulative clinical pregnancy rate.
Cumulative Clinical pregnancy is total case clinical pregnancy per total patient to be enrolled into the study at 12 months after randomization
Measured: 12 months after randomization
Ongoing pregnancy
Having at least 1 gestational sac on ultrasound at 12 weeks' gestation with heart beat activity
Measured: At 12 weeks after embryo placement
Cumulative ongoing pregnancy at 12 months
After 12 months, most patients doing IVF have finished all their frozen embryos; therefore, we consider this time point for analyzing the cumulative ongoing pregnancy rate.
Cumulative ongoing pregnancy is total case ongoing pregnancy per total patient to be enrolled into the study at 12 months after randomization
Measured: 12 months after randomization
Ectopic pregnancy
A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualisation, or histopathology
Measured: At 12 weeks of gestation
Cumulative ectopic pregnancy at 12 months
After 12 months, most patients doing IVF have finished all their frozen embryos; therefore, we consider this time point for analyzing the cumulative ectopic pregnancy rate.
Cumulative ectopic pregnancy is total case ectopic pregnancy per total patient to be enrolled into the study at 12 months after randomization
Measured: 12 months after randomization
Miscarriage
The spontaneous loss of an intra-uterine pregnancy prior to 12 completed weeks of gestational age
Measured: At 12 weeks of gestation
Cumulative miscarriage
After 12 months, most patients doing IVF have finished all their frozen embryos; therefore, we consider this time point for analyzing the cumulative miscarriage rate.
Cumulative miscarriage is total case miscarriage per total patient to be enrolled into the study at 12 months after randomization
Measured: 12 months after randomization
Multiple pregnancy
≥1 gestational sac at early pregnancy ultrasound
Measured: At 6 to 8 weeks' gestation
Cumulative multiple pregnancy
After 12 months, most patients doing IVF have finished all their frozen embryos; therefore, we consider this time point for analyzing the cumulative multiple pregnancy rate.
Cumulative multiple pregnancy is total case multiple pregnancy per total patient to be enrolled into the study at 12 months after randomization
Measured: 12 months after randomization
Vanishing twins
Vanishing twins is defined as a pregnancy with two or more gestational sacs or positive heart beats at 7 weeks of gestation, but only one at 12 weeks' gestation.
Measured: At 12 weeks' gestation
Cumulative vanishing twins
After 12 months, most patients doing IVF have finished all their frozen embryos; therefore, we consider this time point for analyzing the cumulative vanishing twins rate.
Cumulative vanishing twins is total case vanishing twins per total patient to be enrolled into the study at 12 months after randomization
Measured: 12 months after randomization
Multiple delivery
Birth of more than one baby beyond 24 weeks
Measured: At 24 weeks' gestation
Cumulative multiple delivery
After 12 months, most patients doing IVF have finished all their frozen embryos; therefore, we consider this time point for analyzing the cumulative multiple delivery rate.
Cumulative multiple delivery is total case multiple delivery per total patient to be enrolled into the study at 12 months after randomization
Measured: 12 months after randomization
Hypertensive disorders of pregnancy
Pregnancy-induced hypertension, pre-eclampsia and eclampsia
Measured: At 20 weeks of gestation or beyond after the completion of the first transfer
Gestational diabetes mellitus
using a 75g oral glucose tolerance test
Measured: At 24 to 28 weeks of gestation
Cumulative live birth rate
Cumulative live birth rate at 12 months after the randomization.
Measured: At 24 weeks of gestation
Birth weight
Weight of singletons and twins
Measured: At the time of delivery
Low birth weight
Weight < 2500 gm at birth
Measured: At birth
Major congenital abnormalities
Structural, functional, and genetic anomalies, that occur during pregnancy, and identified antenatally, at birth, or later in life, and require surgical repair of a defect, or are visually evident, or are life-threatening, or cause death. 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
High birth weight
Weight >4000 gm at birth
Measured: At birth
Very low birth weight
Weight < 1500 gm at birth
Measured: At birth
Large for gestational age
defined as birth weight >90th centile for gestation, based on standardised ethnicity based charts
Measured: At birth
small for gestational age
defined as less than 10th centile for gestational age at delivery based on standardised ethnicity based charts
Measured: At birth
Very high birth weight
Weight >4500 gm at birth
Measured: At birth
Antepartum haemorrhage
including placenta previa, placenta accreta and unexplained
Measured: At birth
Perinatal mortality
the death of a fetus or infant from 24 weeks of gestation to the end of the neonatal period of 4 weeks after birth.
Measured: 24 weeks of gestation to the end of the neonatal period of 4 weeks after birth
Admission to NICU
The admittance of the newborn to NICU
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start29 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for in Vitro FertilizationStudies 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
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuong M Ho, M.D, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402605
- Sponsor's protocol ID
- 04/2022/MĐ-HĐĐĐ
- Status last verified
- Aug 2022
- First submitted
- 30 May 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Artificial Oocyte Activation With Calcium Ionophore in Low Prognosis Women Classified as POSEIDON Group 4: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05402605
- Acronym / sponsor ID
- 04/2022/MĐ-HĐĐĐ
- Conditions
- in Vitro Fertilization
- Keywords
- POSEIDON, in vitro fertilization, live birth, low prognosis, AOA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 2 Jun 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.
Poor ovarian response (POR) remains one of the significant challenges of Assisted Reproductive Technology (ART). Facing difficulties related to clinical practice, optimizing the embryo culture process is necessary to improve the embryo number and quality in this group of patients. Potential techniques mentioned in the current literature include follicular size at trigger, dual trigger, artificial oocyte activation (AOA), blastocyst transfer, and the role of preimplantation genetic testing for aneuploidy (PGT-A). AOA is currently expected to improve treatment outcomes in poor ovarian responders with the potential for clinical efficacy. However, this issue has not been evaluated before.
Detailed description
Poor ovarian response (POR) remains one of the significant challenges of Assisted Reproductive Technology (ART). Patients with POR yield a low number of oocytes, leading to a low number of useable embryos and a decline in the live birth rate. According to the consensus of the European Society of Human Reproduction and Embryology (ESHRE) in 2011, POR was diagnosed using Bologna criteria. However, some recent studies show the classification by Bologna is not efficient, because the oocyte number should be combined with female age since the likelihood of achieving a live birth among patients with similar oocyte yield ultimately depends on the age of the patient. In 2016, POSEIDON (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number) Group was established and released the new criteria. The POSEIDON criteria proposed a shift from the terminology of POR to the concept of low prognosis. According to POSEIDON criteria, low prognosis account for 30-40% of all stimulated in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles. The low prognosis patient is classified into four groups according to the results of ovarian reserve markers (AMH, AFC, or both), female age, and the number of oocytes retrieved in previous cycles, such as: maternal age < 35, AMH ≥ 1,2 ng/ml and AFC ≥ 5 (subgroup 1a: < 4 oocytes; subgroup 1b: 4-9 oocytes); maternal age ≥ 35, AMH ≥ 1,2 ng/ml and AFC ≥ 5 (subgroup 2a: < 4 oocytes; subgroup 2b: 4-9 oocytes); maternal age < 35, AMH < 1,2 ng/ml and AFC < 5; maternal age ≥ 35, AMH < 1,2 ng/mL and AFC < 5. Although many efforts have been made to improve treatment outcomes in this group of patients, such as researching, understanding, and modifying clinical ovarian stimulation regimens, the results are still not feasible. Especially, group 4, which have advanced maternal age (≥ 35) and seized for 14.4% of low prognosis, has a low cumulative live birth rate (11% in group 4). Female age is a critical element in the POSEIDON classification because age is crucially related to embryo ploidy and more importantly live birth outcome. The probability of having embryo ploidy sharply declined after the age of 34 and was lower than 50% in women aged 35 years and over. Therefore, patients in group 4 will have an increased risk of aneuploidy embryos, decreasing the live birth rate in these groups of patients. A recent study evaluated cumulative live birth rates per cycle, there was a remarkable difference between POSEIDON patients (21, 43, 10, 25, 29, and 17% in groups 1a, 1b, 2a, 2b, 3, and 4, respectively) and non-POSEIDON counterparts (52%). Facing difficulties related to clinical practice, optimizing the embryo culture process is necessary to improve the embryo number and quality in the POR group. Potential techniques include follicular size at the trigger, dual trigger, artificial oocyte activation (AOA), blastocyst transfer, and the role of preimplantation genetic testing for aneuploidy (PGT-A).
In Vietnam, AOA was first reported in 2011, performing on 1588 oocytes, and said the fertilization rate was higher in the ICSI - AOA than in the ICSI group (80.8% vs 74.3%, respectively; p<0.002).
AOA is expected to improve treatment outcomes for low prognosis patients, especially in group 4 by the POSEIDON criteria with the potential for clinical efficacy and safety. Therefore, this study aims to evaluate the effectiveness and safety of AOA on treatment outcomes in low prognosis patients defined by the POSEIDON criteria (2016).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICSI with AOA | Active comparator | Procedure: ICSI with AOAThe oocytes were transferred into the calcium ionophore activation solution for two times of post-ICSI AOA (Ionomycin concentration of 10 µM). Then the oocytes will be washed several times using the medium drops in dish AOA and dish ICSI, then divided into drops with maximum 3 oocytes per drop for culturing. After that, the culture dish will be put in the K-system G185 incubator at 37oC, 6% CO2, and 5% O2. |
| ICSI without AOA | Active comparator | Procedure: ICSI without AOAPost-ICSI oocytes will be cultured in drops containing the Sage - 1 - StepSM medium (maximum 3 oocytes per drop) at 37oC, 6% CO2 and 5% O2 in K-system G185 incubator. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Was diagnosed as low prognosis patients by the POSEIDON criteria in group 4: maternal age ≥ 35 years old, AMH < 1,2 ng/ml and AFC < 5
- Cycles ≤ 3
- Oocytes could be collected with OPU procedure
- Ovarian stimulation with GnRH antagonist protocol
- Agree to participate in the randomization
Key exclusion criteria (11 listed)
- Uterine abnormalities such as unicornuate, bicornuate uterus, didelphys and adenomyosis
- Recent history of any current untreated endocrine abnormality
- Gonadotropin resistance syndrome
- Contraindications of gonadotropins
- Absolute asthernozoospermia
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 |
|---|---|---|
| ICSI with AOAStep 1: All post-ICSI oocytes will be added in the medium drop in AOA dish, these oocytes will be placed in the incubator at 37oC, 6% CO2, and 5% O2 for 20 minutes. Step 2: After 20 minutes, calcium ionophore stock (Sigma-Aldrich - USA) will be diluted into 10µM drops in AOA dish. Step 3: After 10 minutes of incubation, all post-ICSI oocytes will be moved to the AOA drop, then this dish will be put back in the incubator for 10 minutes. Step 4: After 10 minutes, all the oocytes in drop AOA will be moved to another drop for rinsing and then put back in the incubator for 20 minutes. Step 5: After 20 minutes, the oocytes will be moved into drop AOA and then put back in the incubator for 10 minutes. Step 6: After 10 minutes, all post-ICSI oocytes will be added in the medium drop, then divided into drops with maximum 3 oocytes per drop for culturing. After that, the culture dish will be put in the K-system G185 incubator at 37oC, 6% CO2, and 5% O2 | Procedure or surgery | ICSI with AOA |
| ICSI without AOAConventional ICSI procedure will be performed without the application of AOA. | Procedure or surgery | ICSI without AOA |
Primary outcome
Live birth rate
Time frame: At 24 weeks of gestation
The complete expulsion or extraction from a woman of a product of fertilisation, after 24 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 350 grams or more can be used if gestational age is unknown (twins are a single count).
38 secondary outcomes
Fertilization rate
Time frame: One day after oocyte retrieval
Fertilization failure rate
Time frame: One day after oocyte retrieval
Abnormal fertilization rate
Time frame: One day after oocyte retrieval
Total embryos on day 3
Time frame: Three days after oocyte retrieval
Good quality day 3 embryo rate
Time frame: Three days after oocyte retrieval
Total embryos blastocyst
Time frame: Five days after oocyte retrieval
Good quality blastocyst rate
Time frame: Five days after oocyte retrieval
Positive pregnancy test
Time frame: At 2 weeks after embryo placement
Implantation rate
Time frame: At 3 weeks after embryo placement
Cumulative implantation rate at 12 months
Time frame: 12 months after randomization
Clinical pregnancy
Time frame: At 7 weeks after embryo placement]
Cumulative clinical pregnancy at 12 months
Time frame: 12 months after randomization
Ongoing pregnancy
Time frame: At 12 weeks after embryo placement
Cumulative ongoing pregnancy at 12 months
Time frame: 12 months after randomization
Ectopic pregnancy
Time frame: At 12 weeks of gestation
Cumulative ectopic pregnancy at 12 months
Time frame: 12 months after randomization
Miscarriage
Time frame: At 12 weeks of gestation
Cumulative miscarriage
Time frame: 12 months after randomization
Multiple pregnancy
Time frame: At 6 to 8 weeks' gestation
Cumulative multiple pregnancy
Time frame: 12 months after randomization
Vanishing twins
Time frame: At 12 weeks' gestation
Cumulative vanishing twins
Time frame: 12 months after randomization
Multiple delivery
Time frame: At 24 weeks' gestation
Cumulative multiple delivery
Time frame: 12 months after randomization
Hypertensive disorders of pregnancy
Time frame: At 20 weeks of gestation or beyond after the completion of the first transfer
Gestational diabetes mellitus
Time frame: At 24 to 28 weeks of gestation
Cumulative live birth rate
Time frame: At 24 weeks of gestation
Birth weight
Time frame: At the time of delivery
Low birth weight
Time frame: At birth
Major congenital abnormalities
Time frame: At birth
High birth weight
Time frame: At birth
Very low birth weight
Time frame: At birth
Large for gestational age
Time frame: At birth
small for gestational age
Time frame: At birth
Very high birth weight
Time frame: At birth
Antepartum haemorrhage
Time frame: At birth
Perinatal mortality
Time frame: 24 weeks of gestation to the end of the neonatal period of 4 weeks after birth
Admission to NICU
Time frame: At birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Tuong M Ho, M.D 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?
A study testing ICSI with AOA and ICSI without AOA in people with in Vitro Fertilization, 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 5 inclusion and 11 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 30 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuong M Ho, M.D (+84903633377, tuongho.ivfmd@gmail.com), 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 24 weeks of gestation). 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 30 Aug 2022.