NCT06887881

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
766

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Jun 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jun 2025Dec 2028

First Submitted

Initial submission to the registry

January 25, 2024

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 12, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 2, 2026

Status Verified

May 1, 2025

Enrollment Period

3.4 years

First QC Date

January 25, 2024

Last Update Submit

March 29, 2026

Conditions

PGT-APCOSPIMS

Keywords

PIMSPCOSPGT-Acumulative live birth rateearly pregnancy loss rate

Outcome Measures

Primary Outcomes (2)

  • early pregnancy loss rate

    early pregnancy loss rate in one year after randomization

    From enrollment to the end of treatment at 12months

  • cumulative live birth rate per oocyte retrieval cycle

    cumulative live birth rate per oocyte retrieval cycle in one year after randomization

    From enrollment to the end of treatment at 12months

Secondary Outcomes (7)

  • clinical pregnancy rate after initial embryo transfer

    From enrollment to the end of treatment at 12months

  • time to get live birth

    From enrollment to the end of treatment at 12months

  • the rate of a Good Birth Outcome

    From enrollment to the end of treatment at 12months

  • multiple pregnancy rate

    From enrollment to the end of treatment at 12months

  • duration of pregnancy

    From enrollment to the end of treatment at 12months

  • +2 more secondary outcomes

Study Arms (2)

PIMS Group

EXPERIMENTAL

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

PGT-A Group

ACTIVE COMPARATOR

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

Interventions

PIMS screeningGENETIC

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

PIMS Group
PGT-A screeningGENETIC

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.

PGT-A Group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Boai Hospital

Zhongshan, Guangdong, China

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician, professor

Study Record Dates

First Submitted

January 25, 2024

First Posted

March 20, 2025

Study Start

June 12, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 2, 2026

Record last verified: 2025-05

Locations

CN(1)