PGT-ANCT06887881
PIMS vs PGT-A in Infertile PCOS Patients
A study testing PIMS screening and PGT-A screening in people with PGT-A and PCOS, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- What is being tested?
- PIMS screening and PGT-A screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 766 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Boai Hospital
Zhongshan, Guangdong
Study Coordinator, 86+13590705114, zsboai2014@163.com
About this study
Official title: 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.
- Being tested
- PIMS screening, PGT-A screening
- Keywords
- PIMS, PCOS, PGT-A, cumulative live birth rate, early pregnancy loss rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: PGT-A screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
early pregnancy loss rate
early pregnancy loss rate in one year after randomization
Measured: 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
Measured: From enrollment to the end of treatment at 12months
Secondary outcomes (7)
clinical pregnancy rate after initial embryo transfer
Measured: From enrollment to the end of treatment at 12months
time to get live birth
Measured: From enrollment to the end of treatment at 12months
the rate of a Good Birth Outcome
Measured: From enrollment to the end of treatment at 12months
multiple pregnancy rate
Measured: From enrollment to the end of treatment at 12months
duration of pregnancy
Measured: From enrollment to the end of treatment at 12months
birth weight
Measured: From enrollment to the end of treatment at 12months
incidence of maternal and neonatal complications (including fetal anomalies)
Measured: From enrollment to the end of treatment at 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start12 Jun 2025
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PGT-AStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 766 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated Hospital of Guangzhou Medical University, Guangdong Provincial Maternal and Child Health Hospital, Guangzhou Women and Children's Medical Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University Shenzhen Hospital, BoAi Hospital of Zhongshan, Zhuhai Maternal and Child Health Hospital, Shenzhen Maternal and Child Health Hospital, Liuzhou Hospital of Guangzhou Women and Children's Medical Center, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Dongguan Maternal and Children Health Hospital
- Responsible party
- Principal investigator, Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887881
- Sponsor's protocol ID
- [2024]345-2
- Status last verified
- May 2025
- First submitted
- 25 Jan 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06887881
- Acronym / sponsor ID
- [2024]345-2
- Keywords
- PIMS, PCOS, PGT-A, cumulative live birth rate, early pregnancy loss rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 766 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- The Third Affiliated Hospital of Guangzhou Medical University, Guangdong Provincial Maternal and Child Health Hospital, Guangzhou Women and Children's Medical Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University Shenzhen Hospital, BoAi Hospital of Zhongshan, Zhuhai Maternal and Child Health Hospital, Shenzhen Maternal and Child Health Hospital, Liuzhou Hospital of Guangzhou Women and Children's Medical Center, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Dongguan Maternal and Children Health Hospital
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIMS Group | Experimental | Genetic: PIMS screeningCouples 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. |
| PGT-A Group | Active comparator | Genetic: PGT-A screeningCouples 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIMS screeningCouples 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 | Genetic | PIMS Group |
| PGT-A screeningCouples 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. | Genetic | PGT-A Group |
Primary outcome
early pregnancy loss rate
Time frame: From enrollment to the end of treatment at 12months
early pregnancy loss rate in one year after randomization
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
7 secondary outcomes
clinical pregnancy rate after initial embryo transfer
Time frame: 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
the rate of a Good Birth Outcome
Time frame: From enrollment to the end of treatment at 12months
multiple pregnancy rate
Time frame: From enrollment to the end of treatment at 12months
duration of pregnancy
Time frame: From enrollment to the end of treatment at 12months
birth weight
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIMS screening and PGT-A screening in people with PGT-A and PCOS, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early pregnancy loss rate (time frame: From enrollment to the end of treatment at 12months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.