Actively Recruiting
PIMS vs PGT-A in Infertile PCOS Patients
Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2026-04-02
766
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor
T
The Third Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This experiment has become a serious issue for two reasons: DNA methylation plays an important role during embryogenesis, global abnormal methylome reprogramming often occurs in human embryos, and DNA methylome pattern is associated with live birth rate. The endocrine metabolic disorders of polycystic ovarian syndrome (PCOS) patients may affect the epigenetic status of embryos and lead to the increase of early pregnancy loss rate in PCOS patients. However, there is still no technology using DNA methylome as an indicator in preimplantation embryo screening in PCOS patients. Our recent study showed that using Pre-implantation Methylation Screening (PIMS) can select embryos with better methylation state and euploid chromosomes. The efficiency of PIMS in PCOS patients needs further validation through randomized controlled clinical trial. The purpose of the study is to compare whether the two groups of PCOS patients who selected embryos using PIMS and selected embryos using "PGT-A + morphology"had any difference in early pregnancy loss rate. This study aims to explore whether PIMS can be used as another embryo evaluation method besides "PGT-A+morphology" to screen good developmental potential embryos in patients with PCOS. Investigators need to clarify whether a better embryo evaluation system can be established through PIMS technology during assisted reproductive treatment for infertile PCOS couples and provide credible and effective evidence-based medical evidence for the application of PMIS technology in the field of reproductive medicine.
CONDITIONS
Official Title
PIMS vs PGT-A in Infertile PCOS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged between 20 and 40 years diagnosed with PCOS according to international evidence-based guideline for assessment and management of polycystic ovarian syndrome 2018.
- Women who plan to undergo the 1st or 2nd IVF/ICSI/PGT-A treatment cycle.
- Women who obtain 2 or more blastocysts with morphological score of 4BC/4CB or better on Day 5 of embryo culture.
- Culture all cleavage stage embryos into blastocysts, conduct biopsy on all blastocysts, and cryopreserve each blastocyst as a single embryo.
- Agree to the thawing and transfer of a single blastocyst.
- Sign the informed consent form.
You will not qualify if you...
- Women with uterine cavity abnormalities such as congenital malformations (unicornate, bicornate, or duplex uterus), untreated uterine septum, submucous myoma, endometrial polyps, or history of intrauterine adhesions.
- Women indicated for preimplantation genetic testing for structural rearrangements (PGT-SR) or monogenic diseases (PGT-M).
- Women using donated oocytes or sperm to achieve pregnancy.
- Women with contraindications to assisted reproductive technology or pregnancy, including liver disease, renal disease, significant anemia, history of blood clots, uncontrolled hypertension, heart disease, or suspected cancers.
- Untreated hydrosalpinx as diagnosed by ultrasonography.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Boai Hospital
Zhongshan, Guangdong, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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