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NCT04935073
Traditional Chinese Medicine Herbs in the Freeze-all IVF Cycle
Phase 3 trial testing Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu Tang in Infertility, Female in 90 participants. Status unknown.
30 December 2022
Quick facts
| Lead sponsor | Peking University Third Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 15 June 2021 |
| Primary completion | 30 December 2022 |
| Estimated completion | 30 December 2022 |
Drugs / interventions tested
- Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu Tang — full drug profile →
- Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection
Conditions studied
- Infertility, Female — all drugs for Infertility, Female →
Sponsor
Peking University Third Hospital
Who can join
Adults 20 to 40, female only, with Infertility, Female. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In the early stage, the preliminary study found that traditional Chinese medicine (TCM) intervention aimed at Nourishing kidney and regulating blood circulation in freeze-all IVF cycles can improve the clinical pregnancy rate. In order to further study the role of TCM in improving the pregnancy outcome of IVF-ET in infertility. A randomized controlled clinical trial will be used in this study. 90 infertile patients are randomly divided into two groups. The control group will be treated with conventional modern medicine, and the treatment group will be treated with traditional Chinese herbs on the basis of conventional modern medicine. The intervention starts from the 5th day of the menstrual cycle and lasts until the day before IVF-ET. After the transplantation, the TCM treatment continues for 14 days. The number of oocytes, antral follicles, AMH, serum FSH, and clinical pregnancy rate will be observed to evaluate the effect of TCM herbs on the improvement of pregnancy outcomes. In addition, all the participants will be asked to complete the self-evaluation of the anxiety/depression scale on the 7th day of the menstrual cycle, before and after transplantation, to analyze the emotional changes of the subjects during the study. The study will also observe the safety and health economic indicators of TCM treatment, so as to improve the overall efficacy of TCM Combined Application in assisted reproductive technology in the future.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04935073
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04935073 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University Third Hospital
- Last refreshed: 23 June 2021
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