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Clinical, Mechanism and Long-term Management of the Treatment of adenomyosis by Traditional Chinese Medicine--Clinical Observation of Wenyang Huoxue Granules Combined with IVF-ET in the Treatment of Infertility with Adenomyosis

Clinical, Mechanism and Long-term Management of the Treatment of adenomyosis by Traditional Chinese Medicine--Clinical Observation of Wenyang Huoxue Granules Combined with IVF-ET in the Treatment of Infertility with Adenomyosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080996
Enrollment
Unknown
Registered
2024-02-20
Start date
2024-02-20
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

Infertility with Adenomyosis

Interventions

COS experimental group:treated with Wenyang Huoxue Granules
COS placebo group:treated with placebo
FET experimental group:treated with Wenyang Huoxue Granules
FET placebo group:treated with placebo

Sponsors

Guan'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 39 Years

Inclusion criteria

Inclusion criteria: The Impact of Wenyang Huoxue Granules on Ovulation Induction in Patients with Uterine Adenomyosis-Related Infertility: 1. Meeting AM Western diagnostic criteria, with uterine size = 12 weeks.2. Meeting Western diagnostic criteria for infertility, intending to undergo in vitro fertilization-embryo transfer (IVF-ET).3. Meeting Traditional Chinese Medicine (TCM) criteria for Cold Coagulation and Blood Stasis syndrome.4. Age between 25 and 39 years.5. Normal ovarian reserve function: baseline FSH value = 10 IU/mL, AFC (Antral Follicle Count) = 7 or AMH (Anti-Mullerian Hormone) = 1.1 ng/ml.6. BMI (Body Mass Index) = 28 kg/m2. 7. Signed informed consent. The Impact of Wenyang Huoxue Granules on Frozen-Thawed Embryo Transfer in Patients with Uterine Adenomyosis-Related Infertility:1. Meeting AM diagnostic criteria, with uterine size = 12 weeks.2. Meeting TCM criteria for Cold Coagulation and Blood Stasis syndrome.3. Currently having at least =1 high-quality frozen lastocyst or =2 high-quality frozen cleavage-stage embryos.4. Intending to undergo embryo transfer.5. Age between 25 and 39 years.6. Signed informed consent.

Exclusion criteria

Exclusion criteria: The Impact of Wenyang Huoxue Granules on Ovulation Induction in Patients with Uterine Adenomyosis-Related Infertility: Exclusion criteria for meeting any of the following conditions: 1. Uterine size > 12 weeks. 2. Use of hormonal medications within the past month. 3. Presence of malignant tumors, severe cardiovascular, hepatic, renal, hematologic diseases, and serious psychiatric disorders, unsuitable for pregnancy. 4. History of uterine malformation, intrauterine adhesions, thin endometrium, or untreated submucosal uterine fibroids affecting embryo implantation factors. 5. Chromosomal diseases, etc. 6. History of immune system disorders, such as antiphospholipid syndrome, systemic lupus erythematosus, rheumatoid arthritis, etc. 7. Contraindications to ovulation-inducing drugs, such as a history of breast cancer, risk of thrombosis, etc. 8. Untreated hydrosalpinx visible on untreated ultrasound. The Impact of Wenyang Huoxue Granules on Frozen-Thawed Embryo Transfer in Patients with Uterine Adenomyosis-Related Infertility: Exclusion criteria for meeting any of the following conditions: 1. Uterine size > 12 weeks. 2. Use of hormonal medications within the past month. 3. Presence of malignant tumors, severe cardiovascular, hepatic, renal, hematologic diseases, and serious psychiatric disorders, unsuitable for pregnancy. 4. History of uterine malformation, intrauterine adhesions, thin endometrium, or untreated submucosal uterine fibroids affecting embryo implantation factors. 5. Chromosomal diseases, untreated hydrosalpinx. 6. History of immune system disorders, such as antiphospholipid syndrome, systemic lupus erythematosus, rheumatoid arthritis, risk of thrombosis, etc.

Design outcomes

Primary

MeasureTime frame
uterus size;AFC;AMH;ovary size;endometrial thickness;Endometrial VFI;CA199;CA125;E2;FSH;LH;Progesterone;Testosterone;number of oocytes;number of fertilization;number of 2PN;number of good quality embryos;

Secondary

MeasureTime frame
IL-1ß;IL-6;IL-10;IL-8;IL-37;TNF;VEGF;Fe;Ca;Mg;Pb;Cu;

Countries

China

Contacts

Public ContactRuihua Zhao

Ethics Committee of Guan'anmen Hospital, China Academy of Chinese Medical Sciences

rhzh801@126.com+86 136 2102 1092

Outcome results

None listed

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