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Clinical Trial on the Efficacy and Safety of Chang'e Jiali Wan in Improving Postoperative Fertility in Females with Ovarian Endometriosis

Clinical Trial on the Efficacy and Safety of Chang'e Jiali Wan in Improving Postoperative Fertility in Females with Ovarian Endometriosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002638
Enrollment
Unknown
Registered
2025-12-30
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Ovarian Endometriosis

Interventions

Sponsors

Obstetrics and Gynecology Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following criteria: 1.Underwent laparoscopic ovarian cystectomy, with postoperative pathological confirmation of ovarian chocolate cyst (and Endometriosis Fertility Index [EFI] = 5 points); 2.Completed three doses of GnRH agonist (GnRH-a) therapy after laparoscopic ovarian cystectomy (discontinued medication and resumed menstruation); 3.Reproductive-aged females aged 20-40 years with fertility needs; 4.Regular menstrual cycles (28 ± 7 days); 5.Subjects agree to sign the informed consent form. If a subject is unable to read the content of the informed consent, they shall sign it jointly with an impartial witness.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria are excluded from enrollment: 1.Anti-Müllerian Hormone (AMH) 2.28 nmol/L (50 µg/L)), hypogonadotropic hypogonadism, uncontrolled thyroid disease (thyroid-stimulating hormone [TSH] outside the normal reference range), Addison's disease, systemic lupus erythematosus (SLE), Crohn's disease, uncontrolled diabetes mellitus (glycated hemoglobin [HbA1c] > upper limit of normal [ULN]), etc.; 4.Patients with untreated unexplained vaginal bleeding or endometrial hyperplasia; 5.Patients with complicated severe underlying diseases such as cardiovascular and cerebrovascular diseases, hepatic or renal insufficiency, and disorders of the hematopoietic or coagulation systems; 6.Received traditional Chinese medicine, Western medicine, or health supplements for improving decreased ovarian reserve within 14 days prior to screening, or refused to discontinue the use of the aforementioned products during the trial; 7.Patients with malignant tumors of the reproductive organs, benign tumors requiring surgical treatment, or breast tumors; 8.Screening examination results meeting any of the following indicators: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal (ULN), or serum creatinine (Scr) > upper limit of normal (ULN); 9.Presence of tubal infertility factors or male partner with infertility-causing factors; 10.Subjects deemed inappropriate to participate in this trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Positive urine or blood Human Chorionic Gonadotropin(HCG);Ultrasound detection of embryonic bud and fetal heart activity (positive);

Secondary

MeasureTime frame
Serum Sex Hormone Levels;Anti-Müllerian Hormone (AMH) Level;Serum Tumor Marker CA125 Level;Antral follicle counting,AFC;Ovarian volume,OVVOL;Number of Dominant Follicles; Endometrial Thickness During Ovulation;Size of Ovarian Chocolate Cyst;Visual analogue scale, VAS;

Countries

China

Contacts

Public ContactWang Li

Obstetrics and Gynecology Hospital Affiliated to Fudan University

wanglisa1101@163.com+86 138 0175 2101

Outcome results

None listed

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