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Traditional Chinese Medicine Intervention and the Health and Maternal-Fetal Outcomes of Infertile Women with PCOS Throughout the Entire Reproductive Cycle: A Real-World Multicenter Bidirectional Cohort Study

Health status and maternal-fetal outcomes during the entire reproductive cycle of women with polycystic ovary syndrome: A multicenter bidirectional cohort study based on real-world data

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026000704
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-01-26
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome

Interventions

Retrospective cohort:Observational study, without intervention measures
Prospective cohort:Observational study, without intervention measures

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for polycystic ovary syndrome (as defined in the 2023 "International Evidence-Based Guidelines for the Assessment and Management of Polycystic Ovary Syndrome"); 2. Age = 21 years, patients with pregnancy needs/who are pregnant/after childbirth; 3. The completeness of case data is = 70% (core information includes: diagnostic basis, main treatment measures, at least one follow-up record); 4. Prospective cases need to sign an informed consent form (retrospective cases are exempt from informed consent, and ethical approval is required).

Exclusion criteria

Exclusion criteria: 1. The case data is severely lacking (such as without clear diagnostic basis, key diagnostic information not recorded); 2. Complicated with other serious diseases (such as advanced malignant tumors, severe liver and kidney failure) and having other endocrine diseases besides PCOS (such as adrenal tumors, tumors causing hyperandrogenism, etc.), which may interfere with the diagnosis and evaluation of polycystic ovary syndrome; 3. Infertile individuals caused by chromosomal abnormalities of both spouses, tubal factors, organic lesions of reproductive organs or male factors; 4. Prospective cases that refuse to cooperate with follow-up or are unable to provide valid contact information.

Design outcomes

Primary

MeasureTime frame
Pregnancy outcome;Pregnancy complications;Postpartum condition;Newborn birth data;Newborn complications;The condition of the baby;

Secondary

MeasureTime frame
Anti-Müllerian hormone(AMH);Follicle-stimulating hormone(FSH);Luteinizing hormone(LH);Testosterone(T);Thyroid stimulating hormone(TSH);Free triiodothyronine(FT3);Free thyroxine 4-Iodoformate(FT4);Fasting blood glucose(FPG);Fasting insulin(FINS);Insulin resistance index(HOMA-IR);Blood sugar level two hours after the meal(2hPG);Insulin two hours after the meal(2hINS);Total serum cholesterol(TC);Triglyceride(TG);Low-density lipoprotein(LDL-C);High-density lipoprotein(HDL-C);Homocysteine(HCY);25-hydroxyvitamin D(25-OHD);Endometrial thickness(EM);Number of retrieved oocytes;Oocyte retrieval rate;Number of MII oocytes;MII oocyte rate;2PN number;2PN fertilization rate;Number of 2PN eggs;2PN cleavage rate;Number of high-quality embryos in D3 group;D3 high-quality embryo rate;The number of blastocysts formed;Blastocyst formation rate;The number of high-scoring blastocysts;High scoring blastocyst rate;Number of transplantable embryos;Transplantable embryo rate;The incidence rate of OHSS;

Countries

China

Contacts

Public ContactLinling Wu

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

154384118@qq.com13642123194

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026