Actively Recruiting
Effectiveness and Safety of In Vitro Maturation With Fresh Embryo Transfer Versus In Vitro Fertilization With Frozen Embryo Transfer in Women With PCOS
Led by Mỹ Đức Hospital · Updated on 2025-10-01
600
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two fertility treatment methods for women with Polycystic Ovary Syndrome (PCOS): a simplified in vitro maturation (IVM) approach with fresh embryo transfer, known as the SAIGON protocol, and a standard in vitro fertilization (IVF) method with frozen embryo transfer (FET). This study aims to understand how these treatments differ in live birth rates and other pregnancy outcomes, addressing concerns around risks like ovarian hyperstimulation syndrome (OHSS) and treatment burden. Participants will be randomly assigned to one of two groups. In the IVM-Fresh group, treatment starts early in the menstrual cycle with hormone preparation, immature eggs are collected and fertilized, and fresh embryos are transferred within the same cycle. In the IVF-FET group, ovarian stimulation is done with medications, mature eggs are retrieved and fertilized, embryos are frozen, and transferred in a later cycle after hormone preparation. During the study, participants will undergo pregnancy testing 10-14 days after embryo transfer and continue hormone support if pregnant. Researchers will closely monitor outcomes such as live birth rates, ongoing pregnancy, miscarriage, and any treatment or pregnancy complications. Data on delivery and newborn health will also be collected. The study will follow participants for up to 12 months to assess cumulative pregnancy results and safety.
CONDITIONS
Brief Title
IVM - Fresh ET (THE SAIGON PROTOCOL) Versus IVF - FET in PCOS Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 - 42 years old
- Diagnosed with Polycystic Ovary Syndrome (PCOS) using Rotterdam 2003 criteria
- Fewer than three previous failed frozen embryo transfer cycles
- Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts
- Agreeing to participate in the study
You will not qualify if you...
- Allergy or contraindications to hormone treatments, such as breast cancer or blood clotting disorders
- Cycles requiring preimplantation genetic testing
- Oocyte donation cycles
- Untreated uterine or adnexal abnormalities, including intrauterine adhesions, uterine malformations, large fibroids (≥5 cm), adenomyosis, endometrial polyps, or hydrosalpinx
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Same day as the first visit
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 10 days plus embryo transfer timing
Participants start treatment on day 2-4 of the menstrual cycle with oral estradiol valerate for at least 10 days, followed by immature oocyte retrieval when the endometrium is sufficiently thick. Mature oocytes are fertilized via ICSI. Luteal phase support starts on the day of ICSI with vaginal progesterone and dydrogesterone. A fresh embryo transfer is performed 3 or 5 days after progesterone begins, depending on embryo stage.
Multiple visits during endometrial preparation, oocyte retrieval, and embryo transfer
Duration - Duration of ovarian stimulation cycle plus frozen embryo transfer cycle
Participants undergo ovarian stimulation starting on any day of the menstrual cycle with GnRH antagonist protocol and rFSH injections. Oocyte retrieval is triggered when follicles mature, followed by fertilization and embryo cryopreservation. Endometrial preparation for frozen embryo transfer includes oral estradiol valerate and vaginal progesterone once the endometrium reaches adequate thickness. Frozen embryos are thawed and transferred under ultrasound guidance.
Multiple visits for ovarian stimulation monitoring, oocyte retrieval, and embryo transfer
Duration - Up to delivery and one month after birth
Participants have a pregnancy test 10-14 days after embryo transfer. Hormone supplementation continues if pregnancy is confirmed. Pregnancy and neonatal outcomes are monitored up to delivery and one month postpartum, including assessments of pregnancy complications, birth outcomes, and neonatal health.
Visits for pregnancy testing, obstetric assessments, and neonatal follow-up
Trial Site Locations
Total: 1 location
1
IVFMD - My Duc Hospital
Ho Chi Minh City, Vietnam
Actively Recruiting
Research Team
V
Vu NA Ho, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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