PIMS versus PGT-A for embryo selection in women with PCOS
Clinical Use of Preimplantation DNA Methylation Screening (PIMS) and Preimplantation Genetics Screening (PGT-A) in Infertile PCOS Patients-A Multicenter, Prospective Randomized Non-inferior Clinical Trial
This test will see if selecting embryos with Pre-implantation Methylation Screening (PIMS) instead of PGT-A plus standard morphology leads to higher cumulative live birth rates and lower early pregnancy loss for women with PCOS undergoing IVF/ICSI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 766 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Zhongshan, Guangdong) |
| Trial ID | NCT06887881 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study enrolls women aged 20–40 with PCOS who are undergoing their first or second IVF/ICSI cycle and who produce at least two good-quality Day-5 blastocysts. All blastocysts will be biopsied and cryopreserved as single embryos, and participants will be randomized to embryo selection by PIMS or by PGT-A combined with morphological grading, followed by single frozen–thawed blastocyst transfer. Primary outcomes include cumulative live birth rate and early pregnancy loss rate, with methylome profiles guiding selection in the PIMS arm. The trial tests whether methylation-based selection improves reproductive outcomes compared with current genetic plus morphological screening in this population.
Who should consider this trial
Good fit: Women aged 20–40 with PCOS planning their 1st or 2nd IVF/ICSI/PGT-A cycle who produce two or more Day-5 blastocysts with morphological scores of 4BC/4CB or better and who agree to single frozen–thawed blastocyst transfer.
Not a fit: Patients with uterine cavity abnormalities, those needing preimplantation testing for structural rearrangements, women producing fewer than two qualifying blastocysts, or women outside the 20–40 age range are unlikely to be eligible or to benefit from this approach.
Why it matters
Potential benefit: If successful, PIMS could increase live birth rates and reduce early pregnancy loss for women with PCOS by selecting embryos with healthier methylation patterns.
How similar studies have performed: Preliminary data from the sponsoring group indicate PIMS can select embryos with improved methylation states and euploid chromosomes, but randomized evidence in PCOS populations is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women aged between 20 and 40 years diagnosed with PCOS according to international evidence-based guidline for assessment and management of policystic ovarian syndrome 2018. 2. Women who plan to undergo the 1st/2nd IVF/ICSI/PGT-A treatment cycle. 3. Women who obtain 2 or more blastocysts that have morphological score of 4BC/4CB or better on Day 5of embryo culture. 4. Culture all the cleavage stage embryos into blastocysts, conduct biopsy on all the blastocysts, and cryopreserve each blastocyst as a single embryo 5. Agree to the thawing and transfer of a single blastocyst. 6. Sign the informed consent form. Exclusion Criteria: 1. Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus unicornate, bicornate, or duplex); untreated uterine septum, submucous myoma, or endometrial polyp(s); or with history of intrauterine adhesions. 2. Women who are indicated and planned to undergo preimplantation genetic testing for structural rearrangements (PGT-SR) or preimplantation genetic testing for monogenic (PGT-M). 3. Women who use donated oocytes or sperm to achieve pregnancy. 4. Women with contraindication for assisted reproductive technology or for pregnancy, such as undiagnosed liver disease or dysfunction (based on serum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hypertension, known symptomatic heart disease; history of or suspected carcinoma including including cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding and so on. 5. Untreated hydrosalpinx according to ultrasonography test.
Where this trial is running
Zhongshan, Guangdong
- Zhongshan Boai Hospital — Zhongshan, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.