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Impact of Day 2 Versus Day 3 Fresh Embryo Transfer on Live Birth Rate in Poor-Prognosis Patients

A legfontosabb adatok

Ki végzi
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
470 fő, tervezett
Kezdés
2026. márc. 30.
Várható befejezés
2027. dec. 31.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
A vizsgált kezelések
  • Day 2 Fresh Embryo Transfer
A regiszteradat frissítve
2026. április 16.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

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.

Életkor
35 Years to 50 Years
Nem
Women only
A betegség stádiuma
POSEIDON Category 4 low prognosis: age ≥ 35 years with a low egg reserve. Must be in a first or second IVF/ICSI cycle.
Korábbi kezelés
Must be having ovarian stimulation with a GnRH antagonist protocol, with at least 1 egg (oocyte) collected.
Biomarker vagy leletérték
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.

A részvétel fő kizáró okai

  • 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

A regiszter feltételei, szó szerint

Mind a 10 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 35 és 50 év között vagy?

A vizsgálatról

Mit akar kideríteni a vizsgálat

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:

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • D2 Embryo Transfer GroupA vizsgált kezelés

    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.

    Kezelés: Day 2 Fresh Embryo Transfer

  • D3 Embryo Transfer GroupNincs vizsgálati kezelés, összehasonlításként

    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.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
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
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
Illeszkedési kérdések
Forrás: NCT07533695: ki vehet részt
A regiszteradat frissítve
2026. április 16.