PIMS vs PGT-A in Infertile PCOS Patients

March 29, 2026 updated by: Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

766

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Zhongshan, Guangdong, China
        • Recruiting
        • Zhongshan Boai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PIMS Group
Couples in the PIMS group will have up to 6 blastocysts screened with PIMS and a single euploid embryo with the optimal state of whole-genome DNA methylation and the highest morphologic score will be selected for the initial transfer. The optimal state of whole-genome DNA methylation includes methylation level closest to the optimal level (0.26 according to our preliminary results) and proper methylation state for some specific regions.Blastocysts that have undergone a second biopsy will not be preferred.
Genetic: PIMS screening
Couples in the PIMS group will have up to 6 blastocysts screened with PIMS and a single euploid embryo with the optimal state of whole-genome DNA methylation and the highest morphologic score will be selected for the initial transfer
Active Comparator: PGT-A Group
Couples in the PGT-A group will have up to 6 blastocysts screened with PGT-A and a single euploid blastocyst with the highest morphologic score selected for the initial transfer.Blastocysts that have undergone a second biopsy will not be preferred.
Genetic: PGT-A screening
Couples in the PGT-A group will have up to 6 blastocysts screened with PGT-A and a single euploid blastocyst with the highest morphologic score selected for the initial transfer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulative live birth rate per oocyte retrieval cycle
Time Frame: From enrollment to the end of treatment at 12months
cumulative live birth rate per oocyte retrieval cycle in one year after randomization
From enrollment to the end of treatment at 12months
early pregnancy loss rate
Time Frame: From enrollment to the end of treatment at 12months
early pregnancy loss rate in one year after randomization
From enrollment to the end of treatment at 12months

Secondary Outcome Measures

Outcome Measure
Time Frame
the rate of a Good Birth Outcome
Time Frame: From enrollment to the end of treatment at 12months
From enrollment to the end of treatment at 12months
multiple pregnancy rate
Time Frame: From enrollment to the end of treatment at 12months
From enrollment to the end of treatment at 12months
duration of pregnancy
Time Frame: From enrollment to the end of treatment at 12months
From enrollment to the end of treatment at 12months
birth weight
Time Frame: From enrollment to the end of treatment at 12months
From enrollment to the end of treatment at 12months
incidence of maternal and neonatal complications (including fetal anomalies)
Time Frame: From enrollment to the end of treatment at 12months
From enrollment to the end of treatment at 12months
clinical pregnancy rate after initial embryo transfer
Time Frame: From enrollment to the end of treatment at 12months
From enrollment to the end of treatment at 12months
time to get live birth
Time Frame: From enrollment to the end of treatment at 12months
From enrollment to the end of treatment at 12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborators

The Third Affiliated Hospital of Guangzhou Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Peking University Shenzhen Hospital
Dongguan Maternal and Child Health Hospital
Guangzhou Women and Children's Medical Center
Guangdong Provincial Maternal and Child Health Hospital
BoAi Hospital of Zhongshan
Shenzhen Maternal and Child Health Hospital
Liuzhou Hospital of Guangzhou Women and Children's Medical Center
Zhuhai Maternal and Child Health Hospital
Guangxi Zhuang Autonomous Region Maternal and Child Health Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

March 15, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2024]345-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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