RecruitingNot ApplicableNCT07632300

Apply Biphasic IVM for POSEIDON Group 1

Efficacy and Safety of Biphasic IVM in Low Prognosis Patients Classified as Poseidon Group 1A


Sponsor

Mỹ Đức Hospital

Enrollment

25 participants

Start Date

Jun 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if biphasic In Vitro Maturation (IVM) works to help young women who produce very few oocytes after controlled ovarian stimulation. The study focuses on women under age 35 who have a good number of follicles in their ovaries but do not respond well to standard ovarian stimulation by Gonadotropin (known as POSEIDON Group 1a). The main questions it aims to answer are: How many mature oocytes can be obtain after biphasic -VM? Researchers will use biphasic-IVM system to see if it can bypass the problems these patients face with standard treatments, such as high costs and the risk of medical complications like Ovarian Hyperstimulation Syndrome (OHSS). Participants will: Have their immature eggs collected from the ovaries without the need for high-dose hormone injections. Have their eggs matured in a specialized laboratory using a two-step process (biphasic IVM) to improve egg quality. Follow up with researchers to check the number of embryos created and the safety of the procedure.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 35 Years

Inclusion Criteria6

  • Women aged 18 - < 35 years
  • At least one IVF cycle have been failed and classified as having a poor response to POSEIDON group Ia.
  • POSEIDON group Ia ( < 35 age; AMH >= 1.2 ng/ml and/or AFC >=5 antral follicles; have < 4 oocytes was retrieved at previous IVF cycle)
  • Agree to apply biphasic-IVM treatment.
  • Agree to freeze all embryos and to transfer the frozen embryos afterward.
  • Agree to participate in the study.

Exclusion Criteria4

  • Egg-donation cycle
  • Uterine abnormalities: adenomyosis, large uterine fibroids (≥5 cm), bicornuate uterus, uterine adhesions.
  • Sperm surgical (PESA, TESE, mTESE)
  • PGT

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Interventions

PROCEDUREBiphasic-IVM

After consenting to undergo biphasic IVM, patients will be scheduled for immature oocyte retrieval between cycle days 1 and 6. No FSH, hMG, hCG, or GnRH agonist will be administered for oocyte maturation. Oocyte retrieval will be performed transvaginally under ultrasound guidance. A 20G aspiration needle (Kitazato®, Japan or Vitrolife®, Sweden) will be connected to a suction device with a negative pressure of -120 mmHg. Follicular fluid will be transferred to the laboratory for oocyte identification under a stereomicroscope and filtered using a mesh system to avoid oocyte loss. Cumulus-oocyte complexes (COCs) will be washed and placed into four-well culture dishes containing CAPA medium. After 24 hours of prematuration culture in CAPA medium, the oocytes will be transferred to IVM medium for an additional 30 hours. Subsequently, oocytes will be denuded and assessed for nuclear maturation status. Mature oocytes obtained after IVM culture will undergo intracytoplasmic sperm injection.


Locations(1)

IVFMD, My Duc Hospital

Ho Chi Minh City, Hồ Chí Minh, Vietnam

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NCT07632300


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