scholarly journals Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ying Cao ◽  
Peijuan-Wang ◽  
Yan Lu ◽  
Yue Chen ◽  
Si Chen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Sex Hormone ◽  
Endocrine Function ◽  
Premature Ovarian Insufficiency ◽  
Multicenter Clinical Trial ◽  
Childbearing Age ◽  
Ovarian Insufficiency ◽  
Hormone Levels

Abstract Introduction Premature ovarian insufficiency (POI) seriously affects the quality of life, endocrine function, and fertility of women of childbearing age. Currently, hormone replacement therapy for POI has some limitations, either with low efficacies or high side effects. Bushen Huoxue (BSHX) plays an important role in alleviating clinical symptoms and improving health status of POI patients. This placebo-controlled, randomized, double-blind, and multicenter clinical trial protocol aims to evaluate the effectiveness and safety of BSHX in women with POI. Methods and design We plan to recruit 150 women with POI from four participating hospitals in China. Participants will be randomized in a 1:1 to receive oral BSHX or BSHX placebo. All participants will be treated for 3 months and will be followed up for another 3 month. The primary outcome is questionnaire scores based on the changes in the total symptoms, which is the Chinese version of the Menopause-Specific Quality of Life (CMS) (Nie G, Yang H, Liu J, Zhao C, Wang X, Menopause 24(5):546–554, 2017). CMS will be measured before the intervention, at 3 months and 6 months after randomization for all participants. The other measurements include serum sex hormone levels, anti-Müllerian hormone (AMH) levels, ovarian peak systolic velocity (PSV; cm/s), and antral follicle count (AFC). In this study, the regulatory effects of traditional Chinese medicine on hormones were evaluated by the changes of serum sex hormone levels, which include serum estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). These indicators will be measured before intervention and at 3 months after randomization. Ethics and dissemination This study was approved by the Research Ethics Committee of Jiangsu Province Hospital on Integration of Chinese and Western Medicine (2019LWKY014). All participants will provide written informed consent prior to randomization. The results of this research will be presented to academic conferences and peer-reviewed journals. Trial registration ChiCTR1900028451. Registered on 22 December 2019, https://www.chictr.org.cn/index.aspx.

Effectiveness and Safety of Bushen Huoxue in Treatment of Premature Ovarian Insufficiency: study protocol for a randomised, double-blinded, placebo-controlled and multicentre clinical trial

2021 ◽  
Author(s):  
Ying Cao ◽  
Juan Pei Wang ◽  
Yan Lu ◽  
Yue Chen ◽  
Si Chen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Sex Hormone ◽  
Endocrine Function ◽  
Premature Ovarian Insufficiency ◽  
Childbearing Age ◽  
Ovarian Insufficiency ◽  
Multicentre Clinical Trial ◽  
Hormone Levels

Abstract Introduction Premature Ovarian Insufficiency (POI) seriously affects the quality of life, endocrine function, and fertility of women of childbearing age. Currently, Hormone replacement therapy for POI has some limitations, either with low efficacies or high side effects. Bushen Huoxue (BSHX) plays an important role in alleviating clinical symptoms and improving health status of POI patients. This placebo-controlled, randomised, double-blind, and multicentre clinical trial protocol aims to evaluate the effectiveness and safety of BSHX in women with POI.Methods and Design We plan to recruit 150 women with POI from four participating hospitals in China. Participants will be randomised in a 1:1 to receive oral BSHX or BSHX placebo. All participants will be treated for 3-month and will be followed up for another 3-month. The primary outcome is questionnaire scores based on the changes in the total symptoms, which is the Chinese version of the Menopause-Specific Quality of Life (CMS)1. The other measurements include serum sex hormone levels, anti-mullerian hormone (AMH) levels, ovarian peak systolic velocity (PSV; cm/s), and antral follicle count (AFC). In this study, the regulatory effects of traditional Chinese medicine on hormones was evaluated by the changes of serum sex hormone levels, which include serum estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). Ethics and dissemination This study was approved by the Research Ethics Committee of Jiangsu Province Hospital on Integration of Chinese and Western Medicine (2019LWKY014). All participants will provide written informed consent prior to randomization. The results of this research will be presented to academic conferences and peer-reviewed journals.Trial registration number ChiCTR1900028451.Registered 22 December 2019, www.chictr.org.

scholarly journals Premature Ovarian Insufficiency: Procreative Management and Preventive Strategies

Biomedicines ◽  
2018 ◽  
Vol 7 (1) ◽  
pp. 2 ◽  
Author(s):  
Jennifer Chae-Kim ◽  
Larisa Gavrilova-Jordan
Keyword(s):  
Quality Of Life ◽  
At Risk ◽  
Fertility Preservation ◽  
Reproductive Function ◽  
Premature Ovarian Insufficiency ◽  
Preventive Strategies ◽  
Ovarian Insufficiency ◽  
Reproductive Aged Women

Premature ovarian insufficiency (POI) is the loss of normal hormonal and reproductive function of ovaries in women before age 40 as the result of premature depletion of oocytes. The incidence of POI increases with age in reproductive-aged women, and it is highest in women by the age of 40 years. Reproductive function and the ability to have children is a defining factor in quality of life for many women. There are several methods of fertility preservation available to women with POI. Procreative management and preventive strategies for women with or at risk for POI are reviewed.

Relationships between sex hormone levels in men over 50 years of age and body composition, bone quality, and quality of life

2011 ◽  
Vol 35 (9) ◽  
pp. 515-522
Author(s):  
J.M. Martínez-Jabaloyas ◽  
A. Queipo-Zaragozá ◽  
C. Ferrandis-Cortes ◽  
J.A. Queipo-Zaragozá ◽  
M. Gil-Salom ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Body Composition ◽  
Bone Quality ◽  
Sex Hormone ◽  
Hormone Levels

scholarly journals Influence of Sexual Function on the Social Relations and Quality of Life of Women with Premature Ovarian Insufficiency

2018 ◽  
Vol 40 (02) ◽  
pp. 066-071 ◽  
Author(s):  
Daniela Yela ◽  
Patricia Soares ◽  
Cristina Benetti-Pinto
Keyword(s):  
Quality Of Life ◽  
Sexual Function ◽  
Assessment Instrument ◽  
Premature Ovarian Insufficiency ◽  
World Health ◽  
Control Group ◽  
Ovarian Insufficiency ◽  
The Social ◽  
The Impact

Objective To evaluate the impact of sexual function (SF) in the quality of life (QoL) of women with premature ovarian insufficiency (POI). Methods Case-control study in which 80 women with POI were evaluated using estrogen plus progestogen therapy, compared with 80 women matched by age (±2 years) and presenting preserved gonadal function. Sexual function was evaluated using the Female Sexual Function Index (FSFI), and the QoL was evaluated using the World Health Organization's (WHO) QoL assessment instrument (WHOQoL-BREF). Results The mean age of the women with POI and of the control group was 38.4 ± 7.3 years and 38.1 ± 7.3 years respectively. The QoL, was worse among the POI group, and there were significant differences in the physical (63.4 ± 17.4 and 72.7 ± 15.2 respectively, p = 0.0004) and psychological (63.2 ± 14.6 and 69.3 ± 13.9 respectively, p = 0.0075) domains among this group when compared with the control group. Women with POI presented significantly lower arousal, lubrication, orgasm and satisfaction, more dyspareunia and a worse FSFI scores when compared with the control group. All aspects of SF correlate directly with the worsening of the QoL regarding social relationships. Conclusion Women with POI showed worse QoL and SF than the control group. The psychological aspects (desire, excitement, orgasm and sexual satisfaction) of SF had greater influence on the parameters of the QoL, while the physical aspects (pain and lubrication) had a low impact on the QoL. The poor SF in women with POI is directly correlated with a worsening across multiple domains of the QoL; however, the negative impact is particularly important in the social domain. These results suggest that the improvement in sexuality can improve the social interactions of women with POI.

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