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Clinical Study on the Promoting Effect of Modified Dachaihu Decoction on Ovulation Induction in Patients with Liver-meridian heat of Polycystic Ovary Syndrome (PCOS) undergoing Intrauterine Insemination (IUI) Cycle.

Clinical Study on the Promoting Effect of Modified Dachaihu Decoction on Ovulation Induction in Patients with Liver-meridian heat of Polycystic Ovary Syndrome (PCOS) undergoing Intrauterine Insemination (IUI) Cycle.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073706
Enrollment
Unknown
Registered
2023-07-19
Start date
2023-07-14
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

polycystic ovarian syndrome

Interventions

Standard Ovulation Induction Protocol: letrozole + gonadotropin
Combined Chinese medicine and ovulation promotion group:Modified Dachaihu Decoction + Letrozole + Gonadotropin

Sponsors

Quanzhou Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Infertile women who are planning to undergo IUI at the Reproductive Medicine Department of Quanzhou Traditional Chinese Medicine Hospital. 2. Patients who meet the Western medicine diagnostic criteria for PCOS: ? Rare or absent menstruation, or irregular uterine bleeding; ? Clinical anifestations of hyperandrogenism (such as hirsutism, acne) or hyperandrogenemia; ? Ultrasonographic evidence of polycystic ovaries (PCOM), with the presence of =12 follicles measuring 2-9mm in diameter in one or both ovaries, and an ovarian volume =10ml (calculated as 0.5 x longitudinal diameter x transverse diameter x anteroposterior diameter); Among these criteria, ? must be met, and either ? or ? should be met, while other conditions that may cause hyperandrogenism (such as Cushing's syndrome, non-classical congenital adrenal hyperplasia, tumors secreting androgens in the ovaries or adrenal glands) and conditions causing ovulatory dysfunction (such as functional hypothalamic amenorrhea, thyroid disorders, hyperprolactinemia, early ovarian insufficiency, etc.) should be excluded. 3. Patients who meet the traditional Chinese medicine diagnostic criteria for Liver Qi stagnation and Heat syndrome: ? Long-term infertility in marriage; ? Facial acne, distension and fullness in the sides of the body, burning sensation, irritability, easily angered and anxious, or bitter taste and dry mouth; ? Breast distension and pain before menstruation; ? Red tongue with yellow coating; ? Bowstring or wiry pulse. Diagnosis requires the presence of ? and at least 3 of the other listed criteria. 4. Married women aged 21 to 35 years old. 5. At least one patent fallopian tube within the past year. 6. Patients who have undergone three unsuccessful cycles of ovulation induction therapy.

Exclusion criteria

Exclusion criteria: 1) Concurrent presence of other ovarian lesions (such as endometriomas, dermoid cysts, serous cystadenomas, mucinous cystadenomas, and other abnormal ovarian echoes) detected by transvaginal ultrasound examination. 2) Either the male or female partner has acute infections of the genitourinary system or sexually transmitted diseases. 3) Either the male or female partner has severe genetic, physical, or mental health disorders. 4) Either the male or female partner has been exposed to teratogenic doses of radiation, toxins, or drugs during the critical period. 5) Either the male or female partner has a serious history of substance abuse or other harmful addictions.

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate;Ovulation rate;dosage of gonadotropin;timing of gonadotropin administration;

Secondary

MeasureTime frame
endometrial thickness;endometrial classification;Multiple pregnancy rates;Miscarriage rate;Follicle-stimulating hormone (FSH);Luteinising hormone (LH);Total testosterone;

Countries

China

Contacts

Public ContactAiqin Lian

Quanzhou Traditional Chinese Medicine Hospital

lian_aiqin@qq.com+86 152 8010 1713

Outcome results

None listed

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