Day 2 versus Day 3 embryo transfer in women with low fertility prognosis
Compares embryo transfer on Day 2 or Day 3 in women with diminished ovarian reserve.
Key facts
- Who runs it
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Trial code
- Registry title
- Impact of Day 2 Versus Day 3 Fresh Embryo Transfer on Live Birth Rate in Poor-Prognosis Patients
- Status
- Not yet recruiting
- People taking part
- 470 people, planned
- Started
- 30 Mar 2026
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Day 2 Fresh Embryo Transfer
- Record updated
- 16 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 35 or older with a low egg reserve who are having IVF/ICSI. It compares putting a fresh embryo back on Day 2 versus Day 3.
- Age
- 35 Years to 50 Years
- Sex
- Women only
- Disease stage
- POSEIDON Category 4 low prognosis: age ≥ 35 years with a low egg reserve. Must be in a first or second IVF/ICSI cycle.
- Earlier treatment
- Must be having ovarian stimulation with a GnRH antagonist protocol, with at least 1 egg (oocyte) collected.
- Biomarker or test result
- Antral follicle count (AFC) < 5 or anti-Müllerian hormone (AMH) < 1.2 ng/mL. Progesterone must not be > 1.5 ng/mL on the hCG trigger day.
Main reasons for not taking part
- Use of donor eggs or sperm, or planned genetic testing of embryos (PGT)
- Severe immune or chromosome problems
- Problems of the womb cavity, such as submucous fibroids, a complete uterine septum or severe scarring, or an untreated, ultrasound-visible fluid-filled fallopian tube
- Severe other diseases, such as uncontrolled high blood pressure or diabetes, or active cancer
- Embryos failed to implant in ≥2 cycles, or ≥2 miscarriages in the past
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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 take part
- 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)
- 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
- 6: Progesterone level > 1.5 ng/mL on the day of human chorionic gonadotropin (hCG) trigger
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 35 and 50 years old?
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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.
The 2 groups in the trial
- D2 Embryo Transfer GroupTreatment being tested
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.
Treatment: Day 2 Fresh Embryo Transfer
- D3 Embryo Transfer GroupNo study treatment, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Day 2 versus Day 3 embryo transfer in women with low fertility prognosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Fit questions
- Built from NCT07533695, who can take part
- Record updated
- 16 April 2026