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ShouTai Sijunzi Granules improve early pregnancy loss in PCOS patients undergoing letrozole ovulation induction: a randomised controlled trial

ShouTai Sijunzi Granules improve early pregnancy loss in PCOS patients undergoing letrozole ovulation induction: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001228
Enrollment
Unknown
Registered
2025-06-19
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

polycystic ovary syndrome

Interventions

treatment group:Letrozole intervention and ovulation monitoring are the same as control group. After confirming ovulation Shoutai Sijunzi granules. Performe pregnancy diagnosis during the 12th to 14t
control group:Take letrozole tablets from the 2nd day to the 5th day after menstruation or progesterone withdrawal bleeding. Ask subjects to have sex regularly. After confirming ovulation Chinese me

Sponsors

First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.PCOS patients with fertility requirements confirmed diagnosis according to the revised Rotterdam criteria and Chinese diagnosis and treatment guide for PCOS in 2018; 2.TCM syndrome differentiation of PCOS belongs to deficiency of spleen and kidney pattern; 3.Chinese women aged from 20 to 40 years; 4.Owing bilateral ovaries and FSH < 10mIU/L; 5.The husband semen is normal; 6.Presents bilateral or unilateral patency; 7.Informed and consented to participate in the study.

Exclusion criteria

Exclusion criteria: 1.There are obvious factors affecting embryo implantation; 2.Other causes of hyperandrogenism or ovulation disorders; 3.Have taken hormone medications or medications that affect insulin sensitivity within 3 months; 4.Within 6 weeks of pregnancybreastfeedingor post-abortion; 5.One partner of couples with chromosomal abnormality; 6.Spontaneous abortion =2 or more times.

Design outcomes

Primary

MeasureTime frame
The early abortion rate;

Secondary

MeasureTime frame
TCM syndrome score;Serum glucose and lipid metabolism indicators;Ovulation rate;Serum hormone indicators;Pregnancy rate;Endometrial blood perfusion;The usage rate of fetus-preserving drugs;Safety indicators;Adverse pregnancy rate;

Countries

China

Contacts

Public ContactLiu Hua

First Affiliated Hospital of Guangzhou Medical University

drliuh@126.com13556023778

Outcome results

None listed

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