PIMS vs PGT-A in Infertile PCOS Patients (NCT06887881) | Clinical Trial Compass
RecruitingNot Applicable
PIMS vs PGT-A in Infertile PCOS Patients
China766 participantsStarted 2025-06-12
Plain-language summary
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.
Who can participate
Age range
20 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Women who plan to undergo the 1st/2nd IVF/ICSI/PGT-A treatment cycle.
. Women who obtain 2 or more blastocysts that have morphological score of 4BC/4CB or better on Day 5of embryo culture.
. Culture all the cleavage stage embryos into blastocysts, conduct biopsy on all the blastocysts, and cryopreserve each blastocyst as a single embryo
. Agree to the thawing and transfer of a single blastocyst.
. Sign the informed consent form.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares two embryo selection methods — PIMS and PGT-A — for PCOS patients; can you explain what each method involves and how they differ in terms of how our embryos would be evaluated before transfer?
2Since the trial is measuring early pregnancy loss rate and cumulative live birth rate, what does that tell us about what researchers still don't know about which embryo selection approach is safer or more effective for people with PCOS?
3This trial is listed as Phase NA, which often means it's comparing existing clinical procedures rather than testing a new drug — does that change the risk profile, and are there any risks specific to either PIMS or PGT-A that I should weigh?
4Given that I have PCOS, would standard IVF with one of these embryo selection methods already be available to me outside of a trial, and is there a reason you'd recommend participating in a study versus pursuing that directly?
5What would my participation actually look like day-to-day — how many monitoring visits, how long would I be involved, and could the demands of the trial affect my ability to do additional cycles if this one doesn't result in a live birth?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
early pregnancy loss rate
Timeframe: From enrollment to the end of treatment at 12months
2
cumulative live birth rate per oocyte retrieval cycle
Timeframe: From enrollment to the end of treatment at 12months
Trial details
NCT IDNCT06887881
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
. 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.
. Women who are indicated and planned to undergo preimplantation genetic testing for structural rearrangements (PGT-SR) or preimplantation genetic testing for monogenic (PGT-M).
. Women who use donated oocytes or sperm to achieve pregnancy.
. 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.
. Untreated hydrosalpinx according to ultrasonography test.