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New embryo DNA test aims to cut miscarriages in PCOS patients

NCT ID NCT06887881

Knowledge-focused Sponsor: First Affiliated Hospital, Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways to screen embryos in women with polycystic ovary syndrome (PCOS) undergoing IVF. One method looks at DNA methylation patterns (PIMS), while the other checks for chromosome issues (PGT-A). The goal is to see if PIMS can lower the rate of early pregnancy loss. About 766 women aged 20-40 with PCOS will take part across multiple centers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 766 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

COVID-19–associated multisystem inflammatory syndrome in children infertility disorder polycystic ovary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PCOS PGT-A PIMS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zhongshan Boai Hospital

    RECRUITING

    Zhongshan, Guangdong, China

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