Apply Biphasic IVM for POSEIDON Group 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorMỹ Đức Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Egg-donation cycle
Uterine abnormalities: adenomyosis, large uterine fibroids (≥5 cm), bicornuate uterus, uterine adhesions.
Sperm surgical (PESA, TESE, mTESE)
PGT
Trial design
Design model
Single group
Treatments tested in this trial
Biphasic-IVM
Procedure/SurgeryAfter 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Biphasic-IVMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of matured oocytes after biphasic-IVM
Count the number of oocytes with the first polar body extruded after biphasic IVM culture
Time frame
From enrollment to the last of treatment at 12 monthsSecondary outcomes
1
Number of patients have no oocyte retrieved
Count the number of patients with no oocytes retrieved
Time frame
From enrollment to the last of treatment at 12 months2
Number of patients have no matured oocytes after biphasic IVM
Count the number of patients with no matured oocytes after biphasic IVM
Time frame
From enrollment to the last of treatment at 12 months3
Number of patients have no embryos
Count the number of patients with no embryos
Time frame
From enrollment to the end of treatment at 12 months4
Recovery rate
Number of GV oocytes/number of follicles
Time frame
From enrollment to the end of treatment at 12 monthsSponsors and contacts
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Source ClinicalTrials.gov