A prospective study on the endometrium properties and the pregnancy rate of infertile women with thin endometrium receiving Fructus ligustri lucidi used in traditional Chinese medicine.

2023-08-25
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 39(1)
- Xiangyan Ruan
- Zhongting Xu
- Xin Xu
- Yu Yang
- Jiaojiao Cheng
- Suiyu Luo
- Min Min
- Meng Li
- Luping Zhang
- Rui Ju
- Fengyu Jin
- Alfred Otto Mueck

PubMed: 37624969
DOI: 10.1080/09513590.2023.2249997

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 104
Population: 104 patients (aged 20-40 years) receiving either ZGNZC (experimental group, n=55) or not (control group, n=49)
Methods: Prospective, randomized, open-labeled 3-monthly study
Blinding: Open-label
Duration: 3 months

Large Human Trial

Objective

To evaluate whether Zi Gui Nv Zhen capsules (ZGNZC) can increase the fertility rate of Chinese women with infertility due to thin endometrium.

Methods

Prospective, randomized, open-labeled 3-monthly study; 104 patients (aged 20-40 years) receiving either ZGNZC (experimental group, n = 55) or not (control group, n = 49). Main outcomes: thickness/type of the endometrium during ovulation and pregnancy rate. Between-group analysis (A) compares the experimental vs. control group, and within-group analysis (B) compares data at baseline and after study in the experimental group.

Results

(A) Between-group-analysis: Patients with ZGNZC had a higher endometrium thickness (0.8 ± 0.27 vs. 0.68 ± 0.10; p < .05) and higher type A endometrium rates (34.2% vs. 13.2%; p < .05) than the control group. Pregnancy rates were higher in the experimental than in the control group (43.6% vs. 22.4%; p < .05). (B) Within-group-analysis: ZGNZC increased endometrium thickness (0.58 ± 0.13 vs. 0.87 ± 0.24 vs. 0.83 ± 0.26 vs. 0.80 ± 0.27), and type A endometrium rates (10.9% vs. 60.0% vs. 49.0% vs. 34.2%) (all p < .05). Univariate analysis of pregnancy with other study parameters showed positive and significant correlations between pregnancy and administration of ZGNZC (p < .05). All hepato-renal biomarkers remained within the norm. There were no adverse events.

Conclusions

In infertile women with thin endometrium who wish to conceive, two months' application of ZGNZC can improve endometrial properties and proliferation, which is necessary for a healthy pregnancy, and increase the clinical pregnancy rate in our prospective randomized observational study.