PIMS vs PGT-A in Infertile PCOS Patients

Launched by FIRST AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Mar 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for selecting embryos in women with polycystic ovarian syndrome (PCOS) who are trying to conceive through in vitro fertilization (IVF). The trial aims to compare the early pregnancy loss rates between two groups: one group will use a new technique called Pre-implantation Methylation Screening (PIMS), which looks at the DNA methylation of embryos, and the other group will use a combination of traditional embryo evaluation methods, including PGT-A and morphology. Researchers hope to find out if PIMS can help identify embryos with a better chance of successful implantation and pregnancy.

To participate in the trial, women must be between the ages of 20 and 40 and diagnosed with PCOS. They should be planning to undergo IVF and have at least two high-quality embryos available for selection. Participants will undergo standard procedures for embryo culture and biopsy, and they will agree to have one embryo thawed and transferred to attempt pregnancy. The trial is not yet recruiting participants, but it aims to provide important insights into improving embryo selection for women with PCOS, potentially leading to higher success rates in assisted reproductive treatments.

Gender

FEMALE

Eligibility criteria

• 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 IVF/ICSI/PGT-A treatment.
• • 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.