Chinese Herbal Medicine Improves Pregnancy Outcome and Decreases Recurrence Rate after Surgery for Endometriosis-Associated Infertility: A Retrospective Study

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Chinese herbal medicine treatment after laparoscopic surgery for endometriosis-associated infertility improved pregnancy rates and live birth rates while decreasing recurrence rates over five years compared to placebo.

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This retrospective analysis of a randomized, double-blind, placebo-controlled trial evaluated the long-term efficacy of Chinese herbal medicine in 202 women with endometriosis-associated infertility who had undergone laparoscopic surgery. Over a five-year follow-up period, participants receiving herbal treatment demonstrated significantly higher rates of clinical pregnancy and live birth compared to those given a placebo, alongside a markedly lower recurrence rate of endometriosis. The study explicitly notes that while these outcomes were statistically significant, the research design relied on retrospective data collection from an originally prospective trial framework. This paper is centrally about endometriosis — specifically addressing postoperative management strategies for endometriosis-associated infertility and disease recurrence.

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Abstract

OBJECTIVE: To evaluate the long-term efficacy of Chinese herbal medicine (CHM) in enhancing reproductive outcomes and reducing recurrence rates among endometriosis-associated infertility women infertile women. METHODS: This study is a retrospective analysis of a randomized, double-blind, placebo-controlled clinical trial implemented from May 2014 to April 2018. The study included patients with endometriosis-associated infertility who had undergone standardized laparoscopic surgery. After surgery, the participants were randomly assigned to 2 groups: the intervention group received a CHM treatment regimen, while the control group was given placebo therapy. Both groups were subjected to the same blinding procedures and received treatment for a period of 6 months. Five years after surgery, the researchers conducted follow-up with the participants and analysed the data on pregnancy outcomes and recurrence of endometriosis. RESULTS: In this trial, a total of 202 patients with endometriosis-associated infertility (101 per group) were followed up at 5 years post-surgery for clinical pregnancy, live birth, and recurrence outcomes (101 patients per group). According to our data, pregnancies occurred in 83 (82.18%) participants in the CHM group, with a pregnancy rate of 69.02 person-years, and 70 (69.31%) participants in the placebo group, with a pregnancy rate of 42.86 person-years during pregnancy-related median follow-up of 0.75 years [interquartile range (IQR) 0.25-1.71, hazard ratio (HR) 1.451, 95% confidence interval (CI) 1.055-1.997; P=0.017]. Clinical pregnancies occurred in 80 (79.21%) participants in the CHM group, with a clinical pregnancy rate of 64.91 person-years, and in 67 (66.34%) participants in the placebo group, with a clinical pregnancy rate of 39.14 person-years over the course of a median clinical pregnancy-related follow-up of 0.83 years (IQR 0.33-1.83, HR 1.495, 95% CI 1.079-2.072; P=0.012). Live births occurred in 78 (77.23%) participants in the CHM group at a rate of 36.72 person-years and in 60 (59.41%) participants in the placebo group at a rate of 23.94 person-years during the live birth-related median follow-up of 1.79 years (IQR 1.06-3, HR 1.542, 95% CI 1.097-2.165; P=0.010). Recurrence occurred in 12 (11.88%) participants in the CHM group, with a recurrence rate of 2.95 person-years, and in 24 (23.76%) participants in the placebo group, with a recurrence rate of 7.09 person-years (HR 0.458, 95% CI 0.229-0.916; P=0.022) during the recurrence-related median follow-up of 5 years (IQR 1.0-5.0). When assessed within subgroups, the HRs of the intervention on pregnancy and recurrence were similar in participants in different layers (P interaction>0.05). CONCLUSION: CHM can improve postoperative pregnancy outcomes, shorten the time to conception, and reduce the risk of long-term recurrence in infertile patients with endometriosis after laparoscopic surgery. (Registration Number. ChiCTR2300070138).
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Abstract

Objective To evaluate the long-term efficacy of Chinese herbal medicine (CHM) in enhancing reproductive outcomes and reducing recurrence rates among endometriosis-associated infertility women infertile women.

Methods

This study is a retrospective analysis of a randomized, double-blind, placebo-controlled clinical trial implemented from May 2014 to April 2018. The study included patients with endometriosis-associated infertility who had undergone standardized laparoscopic surgery. After surgery, the participants were randomly assigned to 2 groups: the intervention group received a CHM treatment regimen, while the control group was given placebo therapy. Both groups were subjected to the same blinding procedures and received treatment for a period of 6 months. Five years after surgery, the researchers conducted follow-up with the participants and analysed the data on pregnancy outcomes and recurrence of endometriosis.

Results

In this trial, a total of 202 patients with endometriosis-associated infertility (101 per group) were followed up at 5 years post-surgery for clinical pregnancy, live birth, and recurrence outcomes (101 patients per group). According to our data, pregnancies occurred in 83 (82.18%) participants in the CHM group, with a pregnancy rate of 69.02 person-years, and 70 (69.31%) participants in the placebo group, with a pregnancy rate of 42.86 person-years during pregnancy-related median follow-up of 0.75 years [interquartile range (IQR) 0.25–1.71, hazard ratio (HR) 1.451, 95% confidence interval (CI) 1.055–1.997; P=0.017]. Clinical pregnancies occurred in 80 (79.21%) participants in the CHM group, with a clinical pregnancy rate of 64.91 person-years, and in 67 (66.34%) participants in the placebo group, with a clinical pregnancy rate of 39.14 person-years over the course of a median clinical pregnancy-related follow-up of 0.83 years (IQR 0.33–1.83, HR 1.495, 95% CI 1.079–2.072; P=0.012). Live births occurred in 78 (77.23%) participants in the CHM group at a rate of 36.72 person-years and in 60 (59.41%) participants in the placebo group at a rate of 23.94 person-years during the live birth-related median follow-up of 1.79 years (IQR 1.06–3, HR 1.542, 95% CI 1.097–2.165; P=0.010). Recurrence occurred in 12 (11.88%) participants in the CHM group, with a recurrence rate of 2.95 person-years, and in 24 (23.76%) participants in the placebo group, with a recurrence rate of 7.09 person-years (HR 0.458, 95% CI 0.229–0.916; P=0.022) during the recurrence-related median follow-up of 5 years (IQR 1.0–5.0). When assessed within subgroups, the HRs of the intervention on pregnancy and recurrence were similar in participants in different layers (P interaction>0.05).

Conclusion

CHM can improve postoperative pregnancy outcomes, shorten the time to conception, and reduce the risk of long-term recurrence in infertile patients with endometriosis after laparoscopic surgery. (Registration Number. ChiCTR2300070138) Similar content being viewed by others Data Availability The datasets generated during the current study are available from the corresponding author upon reasonable request.

References

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Xu R, Zhang Y, Shi G, Liu Y, Sun WW and Wu Y contributed to the follow-up of the subjects. All authors have read and approved the final manuscript for publication. Corresponding author Ethics declarations No conflict of interest exists in the submission of this manuscript, which is approved by all the authors for publication. Additional information Supported by the Key Projects of the National Science and Technology Pillar Program during the 12th Five-Year Plan Period (No. 2014BAI10B08) Rights and permissions About this article Cite this article Yang, Xc., Han, Q., Xu, R. et al. Chinese Herbal Medicine Improves Pregnancy Outcome and Decreases Recurrence Rate after Surgery for Endometriosis-Associated Infertility: A Retrospective Study. Chin. J. Integr. Med. (2026). https://doi.org/10.1007/s11655-026-4240-7 Accepted: Published: Version of record: DOI: https://doi.org/10.1007/s11655-026-4240-7

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