Actively Recruiting
A Comparative Study of In Vitro Fertilization Outcomes Between PPOS and Antagonist Protocols in Women With Polycystic Ovary Syndrome
Led by Hanoi General Hospital (Vietnam) · Updated on 2026-02-11
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two ovarian stimulation methods used in in vitro fertilization (IVF) for women with polycystic ovary syndrome (PCOS). The study evaluates the progestin-primed ovarian stimulation (PPOS) protocol against the gonadotropin-releasing hormone (GnRH) antagonist protocol to determine differences in IVF outcomes. The trial is sponsored by Hanoi General Hospital in Vietnam and focuses on improving treatment options for women with PCOS-related infertility. Participants will receive ovarian stimulation through one of two protocols: either the PPOS protocol involving gonadotropins combined with oral progestin, or the GnRH antagonist protocol for pituitary suppression. These treatments are part of the IVF process aimed at producing eggs for fertilization. The study uses a randomized design with single blinding to compare the two protocols. The treatment period includes ovarian stimulation lasting approximately 10 to 14 days, followed by egg retrieval and embryo assessment between Day 3 and Day 5 after retrieval. During the study, participants will undergo assessments including ongoing pregnancy checks at 12 weeks after embryo transfer, clinical pregnancy rate evaluations at 6 to 7 weeks, fertilization rates about 16 to 18 hours after insemination, and tracking of live birth rates up to delivery. Researchers will monitor the number of eggs retrieved and mature eggs, as well as the number of usable embryos. The total follow-up for outcomes may last up to 9 to 12 months. Participants are expected to comply with study procedures and provide informed consent before enrollment.
CONDITIONS
Brief Title
Comparison of IVF Outcomes Between PPOS and Antagonist Protocols in Women With PCOS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 40 years
- Diagnosed with polycystic ovary syndrome (PCOS) using the modified Rotterdam criteria (at least 2 of 3: oligo/anovulation, hyperandrogenism, or polycystic ovaries on ultrasound)
- Indicated for in vitro fertilization (IVF) due to PCOS alone or PCOS with other infertility causes
- Eligible for controlled ovarian stimulation for IVF
- Husband or partner has normal sperm or mild to moderate oligoasthenoteratozoospermia (OAT)
- Willing and able to provide written informed consent and follow study procedures
You will not qualify if you...
- Uterine abnormalities that may affect implantation or pregnancy, including congenital malformations, large fibroids, adenomyosis, or severe intrauterine issues
- History of major ovarian or uterine surgery impacting ovarian reserve or uterine structure
- History of recurrent pregnancy loss (3 or more miscarriages)
- Known chromosomal abnormalities in either partner
- Unable to follow study protocol or attend follow-up visits
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 to 14 days
Participants undergo ovarian stimulation using either the progestin-primed ovarian stimulation (PPOS) protocol or the GnRH antagonist protocol as part of in vitro fertilization treatment.
Multiple visits during ovarian stimulation and oocyte retrieval
Duration - Up to 12 weeks after embryo transfer for ongoing pregnancy and up to 9 to 12 months for live birth outcomes
Participants are monitored for pregnancy outcomes including clinical pregnancy, ongoing pregnancy, and live birth.
Visits at 6 to 7 weeks and up to 12 weeks after embryo transfer, with follow-up until delivery
Trial Site Locations
Total: 1 location
1
Hanoi General Hospital
Hanoi, Hanoi, Vietnam, 10000
Actively Recruiting
Research Team
P
Phuong Duy Nguyen, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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