AOA Versus Non-AOA in Low Prognosis Patients by the POSEIDON Criteria
The Effectiveness and Safety of Artificial Oocyte Activation With Calcium Ionophore in Low Prognosis Women Classified as POSEIDON Group 4: a Randomized Clinical Trial
1 other identifier
interventional
528
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedStudy Start
First participant enrolled
August 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedAugust 30, 2022
August 1, 2022
1.3 years
May 30, 2022
August 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
At 24 weeks of gestation
Secondary Outcomes (38)
Fertilization rate
One day after oocyte retrieval
Fertilization failure rate
One day after oocyte retrieval
Abnormal fertilization rate
One day after oocyte retrieval
Total embryos on day 3
Three days after oocyte retrieval
Good quality day 3 embryo rate
Three days after oocyte retrieval
- +33 more secondary outcomes
Study Arms (2)
ICSI with AOA
ACTIVE COMPARATORThe 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 COMPARATORPost-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.
Interventions
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
Conventional ICSI procedure will be performed without the application of AOA.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Surgical sperm retrieval
- Previous low fertilization (\< 30%)
- Globozoospermia
- Cycles using donor oocytes
- Preimplantation Genetic Testing (PGT) cycles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mỹ Đức Hospitallead
Study Sites (1)
IVFMD, My Duc Hospital
Ho Chi Minh City, Vietnam
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuong M Ho, M.D
Mỹ Đức Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2022
First Posted
June 2, 2022
Study Start
August 29, 2022
Primary Completion
December 31, 2023
Study Completion
June 30, 2024
Last Updated
August 30, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share