PIMS versus PGT-A for embryo selection in women with PCOS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study enrolls women aged 20–40 with PCOS who are undergoing their first or second IVF/ICSI cycle and who produce at least two good-quality Day-5 blastocysts. All blastocysts will be biopsied and cryopreserved as single embryos, and participants will be randomized to embryo selection by PIMS or by PGT-A combined with morphological grading, followed by single frozen–thawed blastocyst transfer. Primary outcomes include cumulative live birth rate and early pregnancy loss rate, with methylome profiles guiding selection in the PIMS arm. The trial tests whether methylation-based selection improves reproductive outcomes compared with current genetic plus morphological screening in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Boai Hospital
  Zhongshan, Guangdong, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.