Status:

NOT_YET_RECRUITING

PIMS vs PGT-A in Infertile PCOS Patients

Lead Sponsor:

First Affiliated Hospital, Sun Yat-Sen University

Collaborating Sponsors:

The Third Affiliated Hospital of Guangzhou Medical University

Guangdong Provincial Maternal and Child Health Hospital

Conditions:

PGT-A

PCOS

Eligibility:

FEMALE

20-40 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

May 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2028

Estimated Enrollment :

766 Patients enrolled

Trial Details

Trial ID

NCT06887881

Start Date

May 1 2025

End Date

December 1 2028

Last Update

May 9 2025

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