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A multicenter randomized controlled non-inferiority study on Wenyang Lishui Formula for prevention of ovarian hyperstimulation syndrome (OHSS).

A multicenter randomized controlled non-inferiority study on Wenyang Lishui Formula for prevention of ovarian hyperstimulation syndrome (OHSS).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001658
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-07-31
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

ovarian hyperstimulation syndrome

Interventions

Control group:On the basis of lifestyle intervention letrozole is applied (starting from the oocyte retrieval day 5mg/day orally administered continuous medication for 6 days).

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 35 Years

Inclusion criteria

Inclusion criteria: Translation of Study Inclusion Criteria and Related Definitions Subjects were included if they: Visited the Reproductive Center of Peking University Third Hospital , Peking University First Hospital and Beijing Obstetrics and Gynecology Hospital due to "infertility" for in vitro fertilization (IVF)-assisted reproduction treatment; Underwent controlled ovarian hyperstimulation (COH); Were identified as having a high risk of ovarian hyperstimulation syndrome (OHSS) on the oocyte retrieval day; Had fresh cycle embryo transfer canceled for OHSS prevention. Diagnostic Criteria for Infertility Infertility is a state of subfertility, defined as the failure of a couple to achieve a clinical pregnancy after at least 12 months of regular, unprotected sexual intercourse. Clinical pregnancy refers to the presence of clinical signs of pregnancy, with confirmation by ultrasound of one or more gestational sacs. Population at High Risk of OHSS Referencing the definition used by the Reproductive Center of our hospital, individuals meeting one or more of the following criteria are classified as being at high risk of OHSS: Serum estradiol (E2) level = 15,000 pmol/L on the trigger day; Number of retrieved oocytes = 20; Serum estradiol (E2) level = 10,000 pmol/L and number of retrieved oocytes = 15 on the trigger day. Inclusion Criteria Subjects must meet all the following criteria to be included in the study: (1)Age = 35 years; (2)Body mass index (BMI) 3500 pg/mL or number of retrieved oocytes > 15 on the trigger day; (4)Fresh cycle embryo transfer canceled

Exclusion criteria

Exclusion criteria: (1) Those who do not accept or cannot tolerate traditional Chinese medicine treatment; (2) Those who use drugs that may have a preventive effect on OHSS such as metformin; (3) Those lacking necessary prognostic information; (4) Those who have not signed the informed consent form.

Design outcomes

Primary

MeasureTime frame
Incidence of moderate to severe ovarian hyperstimulation syndrome (OHSS);

Secondary

MeasureTime frame
Vascular Endothelial Growth Factor (VEGF);Ovarian Hyperstimulation Syndrome Clinical Symptoms Self-Assessment Scale;Serum Estradiol;Visual Analogue Scale (VAS) Score;

Countries

China

Contacts

Public ContactXin Xiyun

Peking University Third Hospital

bysyxinxiyan@sina.com13810947856

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026