Clinical trial NCT06887881: PIMS vs PGT-A in Infertile PCOS Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PGT-A
PCOS
PIMS
Keywords: PIMS
PCOS
PGT-A
cumulative live birth rate
early pregnancy loss rate
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: The Third Affiliated Hospital of Guangzhou Medical University
name: Guangdong Provincial Maternal and Child Health Hospital
name: Guangzhou Medical University Affiliated Women and Children's Medical Center
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Peking University Shenzhen Hospital
name: Zhongshan Boai Hospital
name: Zhuhai Maternal and Child Health Hospital
name: Shenzhen Maternal and Child Health Hospital
name: Liuzhou Hospital of Guangzhou Women and Children's Medical Center
name: Guangxi Zhuang Autonomous Region Maternal and Child Health Hospital
First posted: 2025-03-20
Enrollment: 766
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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 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.

Primary outcomes:
measure: early pregnancy loss rate
timeFrame: From enrollment to the end of treatment at 12months
measure: cumulative live birth rate per oocyte retrieval cycle
timeFrame: From enrollment to the end of treatment at 12months
Secondary outcomes:
measure: clinical pregnancy rate after initial embryo transfer
timeFrame: From enrollment to the end of treatment at 12months
measure: time to get live birth
timeFrame: From enrollment to the end of treatment at 12months
measure: the rate of a Good Birth Outcome
timeFrame: From enrollment to the end of treatment at 12months
measure: multiple pregnancy rate
timeFrame: From enrollment to the end of treatment at 12months
measure: duration of pregnancy
timeFrame: From enrollment to the end of treatment at 12months
measure: birth weight
timeFrame: From enrollment to the end of treatment at 12months
measure: incidence of maternal and neonatal complications (including fetal anomalies)
timeFrame: From enrollment to the end of treatment at 12months
Other outcomes:
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