Female Infertility, Polycystic Ovary Syndrome (PCOS)
Conditions
Brief summary
This study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol.
Interventions
DRUGProgestin-Primed Ovarian Stimulation (PPOS)
Ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol, including gonadotropins combined with oral progestin for pituitary suppression during in vitro fertilization treatment.
Ovarian stimulation using a gonadotropin-releasing hormone (GnRH) antagonist protocol for pituitary suppression during in vitro fertilization treatment.
Sponsors
Hanoi General Hospital (Vietnam)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-40 years * Diagnosed with polycystic ovary syndrome (PCOS) according to the modified Rotterdam criteria (2004) (≥2 of 3: oligo/anovulation, hyperandrogenism, or polycystic ovarian morphology on ultrasound) * Indicated for in vitro fertilization (IVF) due to PCOS alone or PCOS with other infertility factors (e.g., tubal factor, previous failed IUI) * Eligible for controlled ovarian stimulation for IVF * Husband/partner with normal sperm parameters or mild to moderate oligoasthenoteratozoospermia (OAT) * Willing and able to provide written informed consent and comply with study procedures.
Exclusion criteria
* Uterine abnormalities that may impair implantation or pregnancy outcomes, including congenital uterine malformations, large fibroids distorting the uterine cavity, adenomyosis, or severe intrauterine pathology. * History of major ovarian or uterine surgery affecting ovarian reserve or uterine structure (e.g., ovarian cystectomy, endometriosis surgery, myomectomy, unilateral oophorectomy) * History of recurrent pregnancy loss (≥3 spontaneous miscarriages) * Known chromosomal abnormalities in either partner * Inability to adhere to study protocol or follow-up procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate at 12 weeks | Up to 12 weeks after embryo transfer | Ongoing pregnancy defined as a viable intrauterine pregnancy with fetal cardiac activity confirmed by ultrasound at or beyond 12 weeks of gestation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Oocytes Retrieved | From ovarian stimulation start to oocyte retrieval (approximately 10-14 days) | Total number of oocytes retrieved per ovarian stimulation cycle at the time of oocyte retrieval |
| Number of Mature (MII) Oocytes | At the time of oocyte retrieval (approximately 10-14 days after stimulation start) | Number of mature oocytes at the metaphase II (MII) stage identified at the time of oocyte retrieval |
| Live birth rate | Up to delivery (approximately 9-12 months after embryo transfer) | Live birth rate of live-born infants at ≥24 weeks of gestation or with birth weight ≥500 g and signs of life after birth. |
| Clinical pregnancy rate | 6-7 weeks after embryo transfer | Clinical pregnancy defined as the presence of a gestational sac with fetal cardiac activity confirmed by ultrasound |
| Fertilization Rate | 16-18 hours after oocyte insemination | Fertilization rate, defined as the percentage of fertilized oocytes |
| Number of Usable Embryos | From fertilization to embryo assessment (approximately Day 3 to Day 5 after oocyte retrieval). | — |
Countries
Vietnam
Contacts
CONTACTPhuong Duy Nguyen, MD, MSc - PI
CONTACTAnh Huynh Phuong Nguyen, MD, MSc, Study Coordinator
PRINCIPAL_INVESTIGATORPhuong Duy Nguyen, MD, MS
Hanoi General Hospital
Outcome results
None listed