POSEIDON Category 4NCT07533695
Impact of Day 2 Versus Day 3 Fresh Embryo Transfer on Live Birth Rate in Poor-Prognosis Patients
A study testing Day 2 Fresh Embryo Transfer in people with POSEIDON Category 4 and Low Prognosis in Assisted Reproductive Technology, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial summary
This study aimed to compare the efficacy (live birth rate) of fresh embryo transfer on Day 2 versus Day 3 in POSEIDON Group 4 patients, and to determine the optimal timing of embryo transfer for this population. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- POSEIDON Category 4, Low Prognosis in Assisted Reproductive Technology, Female Infertility Due to Diminished Ovarian Reserve
- What is being tested?
- Day 2 Fresh Embryo Transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 31 Dec 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 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1: Meet the definition of POSEIDON Category 4: age ≥ 35 years, with antral follicle count (AFC) < 5 or anti-Müllerian hormone (AMH) < 1.2 ng/mL
- 2: Undergoing first or second IVF/ICSI cycle
- 3: Undergoing controlled ovarian hyperstimulation (COH) using a gonadotropin-releasing hormone (GnRH) antagonist protocol, with at least 1 oocyte retrieved
- 4: Provide written informed consent
Who cannot join
- 1: Use of donor oocytes/sperm, or planned preimplantation genetic testing (PGT)
- 2: Severe immune or chromosomal abnormalities
- 3: Uterine cavity abnormalities (i.e., submucous fibroids, complete uterine septum, severe intrauterine adhesions, etc.) or untreated, ultrasound-visible hydrosalpinx
- 4: Presence of severe underlying diseases (e.g., uncontrolled hypertension/diabetes mellitus, active malignant tumors)
- 5: History of recurrent implantation failure (≥2 cycles) or recurrent miscarriage (≥2 episodes)
- 6: Progesterone level > 1.5 ng/mL on the day of human chorionic gonadotropin (hCG) trigger
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Day 2 Versus Day 3 Fresh Embryo Transfer on Live Birth Rate in Poor-Prognosis POSEIDON Group 4 Patients: A Single-Center, Parallel-Group, Open-Label Randomized Controlled Trial
This study aimed to compare the efficacy (live birth rate) of fresh embryo transfer on Day 2 versus Day 3 in POSEIDON Group 4 patients, and to determine the optimal timing of embryo transfer for this population. It is a single-center, parallel-group, open-label prospective randomized controlled trial, and outcome assessors are masked. The main questions it aims to answer are:
Is there a significant difference in the live birth rate between Day 2 and Day 3 fresh embryo transfer in patients with POSEIDON Category 4 low prognosis? What are the differences in secondary outcomes (including clinical pregnancy rate, ongoing pregnancy rate, implantation rate, embryo utilization rate, miscarriage rate, incidence of moderate/severe OHSS, and adverse neonatal outcomes) between the two embryo transfer timings, and which timing is safer and more effective for this patient population?
Read more
A total of 470 patients meeting the POSEIDON Category 4 criteria will be enrolled and randomly assigned to the Day 2 Fresh Embryo Transfer Group and the Day 3 Fresh Embryo Transfer Group in a 1:1 ratio using stratified block randomization. Researchers will compare the two groups to clarify the difference in live birth rate (primary outcome) and other secondary outcomes, so as to determine the optimal embryo transfer timing.
Participants will:
- Be female patients aged ≥ 35 years with antral follicle count (AFC) < 5 or anti-Müllerian hormone (AMH) < 1.2 ng/mL, undergoing the first or second IVF/ICSI cycle, receiving controlled ovarian hyperstimulation (COH) with the GnRH antagonist protocol, and having ≥ 1 oocyte retrieved (excluding those using donor oocytes/sperm, with uterine cavity abnormalities, or complicated with severe underlying diseases).
- Be randomly assigned to either the Day 2 Fresh Embryo Transfer Group or the Day 3 Fresh Embryo Transfer Group, and receive embryo transfer according to the corresponding group's protocol
- Receive routine luteal support treatment after embryo transfer
- Attend follow-up visits at multiple time points (on the day of transfer, 12-15 days after transfer, 28 days after transfer, during pregnancy, and after delivery) to collect relevant clinical and laboratory data for outcome assessment.
- Undergo safety evaluation throughout the study; the study will adopt intention-to-treat (ITT) as the main statistical method and per-protocol (PP) as the sensitivity analysis, with subgroup analysis by age, AMH level, and number of oocytes retrieved, following ethical norms and data quality control requirements.
- Conditions
- POSEIDON Category 4, Low Prognosis in Assisted Reproductive Technology, Female Infertility Due to Diminished Ovarian Reserve
- Being tested
- Day 2 Fresh Embryo Transfer
- Keywords
- fresh embryo transfer, in-vitro fertilization, POSEIDON, low prognosis, diminished ovarian reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day 2 Fresh Embryo TransferProcedure or surgery
Embryos will be cultured for 44-48 hours after oocyte retrieval (Day 2), and embryos with ≥ 2 cells, grade II or above, and no multinucleation will be selected for transfer, with 1-2 embryos transferred; routine luteal support treatment will be given after transfer.
| Study group | Role | What they receive |
|---|---|---|
| D2 Embryo Transfer Group | Experimental | Embryos will be cultured for 44-48 hours after oocyte retrieval (Day 2), and embryos with ≥ 2 cells, grade II or above, and no multinucleation will be selected for transfer, with 1-2 embryos transferred; routine luteal support treatment will be given after transfer. Receives: Procedure: Day 2 Fresh Embryo Transfer |
| D3 Embryo Transfer Group | No intervention | Embryos will be cultured for 68-72 hours after oocyte retrieval (Day 3), and embryos with ≥ 6 cells, grade II or above, and no multinucleation will be selected for transfer, with 1-2 embryos transferred; routine luteal support treatment will be given after transfer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Live birth rate, defined as the delivery of at least one neonate with heartbeat and breathing at ≥ 28 weeks of gestation.
Measured: From enrollment to delivery
Secondary outcomes (11)
Congenital malformation rate
The proportion of participants who achieved a live birth and delivered a newborn diagnosed with a congenital malformation according to the International Classification of Diseases (ICD-10).
Measured: From enrollment to 1 month after delivery
Low birth weight rate
The proportion of participants who achieved a live birth and delivered a newborn with a birth weight of less than 2500g.
Measured: From enrollment to the delivery
Embryo utilization rate
The proportion of all obtained fertilized embryos (2PN zygotes) that are available for subsequent embryo transfer.
Measured: Day 2 or Day 3 after oocyte retrieval
Moderate/severe OHSS incidence rate
The proportion of participants enrolled in the study who developed moderate or severe ovarian hyperstimulation syndrome (OHSS), meeting the criteria of the Royal College of Obstetricians and Gynaecologists (RCOG), between oocyte retrieval and 12 weeks of gestation.
Measured: From oocyte retrieval to 12 weeks of gestation
Miscarriage rate
The proportion of participants who experienced a clinical pregnancy and subsequently had a spontaneous pregnancy loss before 28 weeks of gestation.
Measured: From enrollment to ≤28 weeks of gestation
Clinical pregnancy rate
The proportion of participants enrolled in the study who experienced a clinical pregnancy, defined as the confirmation of an intrauterine gestational sac via ultrasound examination 28 days after embryo transfer.
Measured: From enrollment to 28 days after embryo transfer
Implantation rate
The proportion of all transferred embryos that developed into an intrauterine gestational sac, as confirmed by ultrasound examination 28 days after embryo transfer.
Measured: From enrollment to 28 days after embryo transfer
Rate of no available embryos
The proportion of participants enrolled in the study who, following ovarian stimulation, oocyte retrieval, and embryo culture, have no embryos available for transfer.
Measured: Day 2 or Day 3 after oocyte retrieval
Biochemical pregnancy rate
The proportion of participants enrolled in the study who experienced a biochemical pregnancy, defined as a serum HCG level ≥25 IU/L measured 14 or 15 days after embryo transfer.
Measured: From enrollment to 14 days (D3) or 15 days (D2) after embryo transfer
Preterm birth rate
The proportion of participants who achieved a live birth and delivered between 28 and 36⁺⁶ weeks of gestation.
Measured: From enrollment to the delivery
Ongoing pregnancy rate
The proportion of participants enrolled in the study who experienced an ongoing pregnancy, defined as the confirmation of an intrauterine viable fetus via ultrasound examination at 12 weeks of gestation.
Measured: From enrollment to 12 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POSEIDON Category 4Studies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533695
- Sponsor's protocol ID
- SH9H-2026-T107-1
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), along with the study protocol and statistical analysis plan, will be made publicly available via the National Clinical Research Data Sharing Platform (https://www.ncmc-data.org) within 12 months after study completion. The data will be accessible to qualified researchers in compliance with relevant laws, regulations, and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Day 2 Versus Day 3 Fresh Embryo Transfer on Live Birth Rate in Poor-Prognosis POSEIDON Group 4 Patients: A Single-Center, Parallel-Group, Open-Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07533695
- Acronym / sponsor ID
- SH9H-2026-T107-1
- Conditions
- POSEIDON Category 4, Low Prognosis in Assisted Reproductive Technology, Female Infertility Due to Diminished Ovarian Reserve
- Keywords
- fresh embryo transfer, in-vitro fertilization, POSEIDON, low prognosis, diminished ovarian reserve
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Apr 2026 (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.
This study aimed to compare the efficacy (live birth rate) of fresh embryo transfer on Day 2 versus Day 3 in POSEIDON Group 4 patients, and to determine the optimal timing of embryo transfer for this population. It is a single-center, parallel-group, open-label prospective randomized controlled trial, and outcome assessors are masked. The main questions it aims to answer are:
Is there a significant difference in the live birth rate between Day 2 and Day 3 fresh embryo transfer in patients with POSEIDON Category 4 low prognosis? What are the differences in secondary outcomes (including clinical pregnancy rate, ongoing pregnancy rate, implantation rate, embryo utilization rate, miscarriage rate, incidence of moderate/severe OHSS, and adverse neonatal outcomes) between the two embryo transfer timings, and which timing is safer and more effective for this patient population?
A total of 470 patients meeting the POSEIDON Category 4 criteria will be enrolled and randomly assigned to the Day 2 Fresh Embryo Transfer Group and the Day 3 Fresh Embryo Transfer Group in a 1:1 ratio using stratified block randomization. Researchers will compare the two groups to clarify the difference in live birth rate (primary outcome) and other secondary outcomes, so as to determine the optimal embryo transfer timing.
Participants will:
- Be female patients aged ≥ 35 years with antral follicle count (AFC) < 5 or anti-Müllerian hormone (AMH) < 1.2 ng/mL, undergoing the first or second IVF/ICSI cycle, receiving controlled ovarian hyperstimulation (COH) with the GnRH antagonist protocol, and having ≥ 1 oocyte retrieved (excluding those using donor oocytes/sperm, with uterine cavity abnormalities, or complicated with severe underlying diseases).
- Be randomly assigned to either the Day 2 Fresh Embryo Transfer Group or the Day 3 Fresh Embryo Transfer Group, and receive embryo transfer according to the corresponding group's protocol
- Receive routine luteal support treatment after embryo transfer
- Attend follow-up visits at multiple time points (on the day of transfer, 12-15 days after transfer, 28 days after transfer, during pregnancy, and after delivery) to collect relevant clinical and laboratory data for outcome assessment.
- Undergo safety evaluation throughout the study; the study will adopt intention-to-treat (ITT) as the main statistical method and per-protocol (PP) as the sensitivity analysis, with subgroup analysis by age, AMH level, and number of oocytes retrieved, following ethical norms and data quality control requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D2 Embryo Transfer Group | Experimental | Procedure: Day 2 Fresh Embryo TransferEmbryos will be cultured for 44-48 hours after oocyte retrieval (Day 2), and embryos with ≥ 2 cells, grade II or above, and no multinucleation will be selected for transfer, with 1-2 embryos transferred; routine luteal support treatment will be given after transfer. |
| D3 Embryo Transfer Group | No intervention | –Embryos will be cultured for 68-72 hours after oocyte retrieval (Day 3), and embryos with ≥ 6 cells, grade II or above, and no multinucleation will be selected for transfer, with 1-2 embryos transferred; routine luteal support treatment will be given after transfer. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1: Meet the definition of POSEIDON Category 4: age ≥ 35 years, with antral follicle count (AFC) < 5 or anti-Müllerian hormone (AMH) < 1.2 ng/mL
- 2: Undergoing first or second IVF/ICSI cycle
- 3: Undergoing controlled ovarian hyperstimulation (COH) using a gonadotropin-releasing hormone (GnRH) antagonist protocol, with at least 1 oocyte retrieved
- 4: Provide written informed consent
Key exclusion criteria (6 listed)
- 1: Use of donor oocytes/sperm, or planned preimplantation genetic testing (PGT)
- 2: Severe immune or chromosomal abnormalities
- 3: Uterine cavity abnormalities (i.e., submucous fibroids, complete uterine septum, severe intrauterine adhesions, etc.) or untreated, ultrasound-visible hydrosalpinx
- 4: Presence of severe underlying diseases (e.g., uncontrolled hypertension/diabetes mellitus, active malignant tumors)
- 5: History of recurrent implantation failure (≥2 cycles) or recurrent miscarriage (≥2 episodes)
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 |
|---|---|---|
| Day 2 Fresh Embryo TransferEmbryos will be cultured for 44-48 hours after oocyte retrieval (Day 2), and embryos with ≥ 2 cells, grade II or above, and no multinucleation will be selected for transfer, with 1-2 embryos transferred; routine luteal support treatment will be given after transfer. | Procedure or surgery | D2 Embryo Transfer Group |
Primary outcome
Live birth rate
Time frame: From enrollment to delivery
Live birth rate, defined as the delivery of at least one neonate with heartbeat and breathing at ≥ 28 weeks of gestation.
11 secondary outcomes
Congenital malformation rate
Time frame: From enrollment to 1 month after delivery
Low birth weight rate
Time frame: From enrollment to the delivery
Embryo utilization rate
Time frame: Day 2 or Day 3 after oocyte retrieval
Moderate/severe OHSS incidence rate
Time frame: From oocyte retrieval to 12 weeks of gestation
Miscarriage rate
Time frame: From enrollment to ≤28 weeks of gestation
Clinical pregnancy rate
Time frame: From enrollment to 28 days after embryo transfer
Implantation rate
Time frame: From enrollment to 28 days after embryo transfer
Rate of no available embryos
Time frame: Day 2 or Day 3 after oocyte retrieval
Biochemical pregnancy rate
Time frame: From enrollment to 14 days (D3) or 15 days (D2) after embryo transfer
Preterm birth rate
Time frame: From enrollment to the delivery
Ongoing pregnancy rate
Time frame: From enrollment to 12 weeks of gestation
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 16 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), along with the study protocol and statistical analysis plan, will be made publicly available via the National Clinical Research Data Sharing Platform (https://www.ncmc-data.org) within 12 months after study completion. The data will be accessible to qualified researchers in compliance with relevant laws, regulations, and ethical requirements.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Day 2 Fresh Embryo Transfer in people with POSEIDON Category 4 and Low Prognosis in Assisted Reproductive Technology, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 SHUTIAN JIANG, Medical Doctor (021-23271699, shutiansweet@126.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: From enrollment to delivery). 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 16 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.