scholarly journals Effect of traditional Chinese medicine formula Guilu Xian on in vitro fertilization and embryo transfer outcome in older women with low prognosis: study protocol for a prospective, multicenter, randomized double-blind study

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yingjie Ma ◽  
Xianling Cao ◽  
Jingyan Song ◽  
Dandan Gao ◽  
Xinlei Wang ◽  
...  

Abstract Introduction In recent years, the prevalence of infertility has significantly increased and has become a global reproductive health problem. The female ovarian reserves have been shown to decrease progressively with an increase in age. Besides, the rate of embryo implantation and clinical pregnancy also decreases. Traditional Chinese medicine has been widely applied in assisted reproductive technology. It is reported to have a significant influence on improving the quality of oocytes, improving endometrial receptivity, increasing clinical pregnancy rate, reducing pregnancy-related complications, etc. Therefore, this study will investigate the effect of Guilu Xian, a traditional Chinese medicine formula on IVF-ET outcome in older women with low prognosis. Methods and analysis This trial is a prospective, multicenter, randomized double-blind clinical trial. A total of 120 infertile patients with low prognosis and receiving IVF or ICSI in 3 public hospitals in China will be randomly divided into two parallel groups: Guilu Xian group (n = 60) and placebo group (n = 60). Patients in both groups will be treated with antagonist regimens to promote ovulation, and all the patients will be required to take the medication from the 2nd to 4th day of the menstrual cycle to the day of egg retrieval. A comparison of the total number of oocytes obtained, the fertilization rate, clinical pregnancy rate, embryo quality, embryo implantation rate, and early spontaneous abortion rate between the experimental group and the placebo group will be performed. Trial registration Chinese Clinical Trials Registry ChiCTR1900028255. Registered on 16 December 2019.

2021 ◽  
Author(s):  
Zhengao Sun ◽  
Yingjie Ma ◽  
Xianling Cao ◽  
Yi Zhang ◽  
Dandan Gao ◽  
...  

Abstract IntroductionIn recent years, the prevalence of infertility has significantly increased and has become a global reproductive health problem. The female ovarian reserves have been shown to decrease progressively with an increase in age. Besides, the rate of embryo implantation and clinical pregnancy also decreases. Traditional Chinese medicine has been widely applied in assisted reproductive technology. It is reported to have a significant influence on improving the quality of oocytes, improving endometrial receptivity, increasing clinical pregnancy rate, reducing pregnancy-related complications, etc. Therefore, this study will investigate the effect of Guilu Xian, a traditional Chinese medicine formula on IVF-ET outcome in older women with low prognosis.Methods and analysisThis trial is a prospective, multicenter, randomized double-blind clinical trial. A total of 120 infertile patients with low prognosis and receiving IVF or ICSI in 3 public hospitals in China will be randomly divided into two parallel groups: Guilu Xian group (n = 60) and placebo group (n = 60). Patients in both groups will be treated with antagonist regimens to promote ovulation, and all the patients will be required to take the medication from the 2nd to 4th day of the menstrual cycle to the day of egg retrieval. A comparison of the total number of oocytes obtained, the fertilization rate, clinical pregnancy rate, embryo quality, embryo implantation rate and early spontaneous abortion rate between the experimental group and the placebo group will be performed. This study was registered in the Chinese Clinical Trials Registry Platform (ChiCTR1900028255).


2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Zahra Dehbashi ◽  
Shaheen Khazali ◽  
Fateme Davari Tanha ◽  
Farnaz Mottahedian ◽  
Mahsa Ghajarzadeh ◽  
...  

Abstract Background Endometriosis can exert obvious negative effects on women’s quality of life. Excisional surgery is among the most effective treatments for severe pelvic endometriosis. The prevalence of severe pelvic adhesions following a laparoscopic examination of severe endometriosis varies between 50 and 100%. Temporary intraoperative ovarian suspension is a method for the reduction of adhesions is in the treatment of severe pelvic endometriosis. Given the importance and the prevalence of endometriosis and its complications, we conducted the present study to determine more effective adhesion-reducing methods with a view to improving the quality of the treatments provided. Methods The present prospective double-blind randomized clinical trial was conducted on 50 women of reproductive age (≥ 19 years) diagnosed with severe pelvic endometriosis on transvaginal ultrasound scans and vaginal examinations at Yas Hospital between 2014 and 2017. Women with severe endometriosis (stage III, stage IV, and deep infiltrating endometriosis) requiring an extensive bilateral dissection of the pelvic walls and the rectovaginal space, with preserved uterus and ovaries, were included in the study. The preoperative severity of ovarian adhesions was assessed in terms of ovarian motility, measured through a combination of gentle pressures applied with the vaginal probe and abdominal pressures applied with the examiner’s free hand. A table of random numbers was used to choose which ovary to suspend. The entire study population received standard general anesthesia. In the laparoscopic examination of the cases with severe endometriosis, both ovaries were routinely suspended to the anterior abdominal wall with PROLENE sutures. At the end of the surgery, one of the ovaries was kept suspended for 7 days, whereas the other ovarian suspension suture was cut. At 3 months postoperatively, all the patients underwent ultrasound scans for the assessment of ovarian motility and adhesions. The severity of pelvic pain was defined according to a visual analog score. After surgery, infertile women were followed for 2-4 years, and were contacted regarding the infertility treatment. Chemical and clinical pregnancy rates was compered between the two groups. Results Three months after laparoscopy, the adhesions were mild in 41 (82%) patients and moderate in 9 (18%) on the suspended side, and mild in 12 (24%) patients and moderate in 38 (76%) on the control side (P < 0.001). The mean dysmenorrhea score was 6.8 ± 1.5 before surgery and 4.5 ± 1.4 after surgery (P < 0.001). The chemical pregnancy rate and clinical pregnancy rate were not different in the suspended and control groups (P = 0. 62, P = 0.64). Conclusions The reduction in adhesions via ovarian suspension surgery promises reductions in the complications of endometriosis.


2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Tal Lazer ◽  
Shir Dar ◽  
Ekaterina Shlush ◽  
Basheer S. Al Kudmani ◽  
Kevin Quach ◽  
...  

We examined whether treatment with minimum-dose stimulation (MS) protocol enhances clinical pregnancy rates compared to high-dose stimulation (HS) protocol. A retrospective cohort study was performed comparing IVF and pregnancy outcomes between MS and HS gonadotropin-antagonist protocol for patients with poor ovarian reserve (POR). Inclusion criteria included patients with an anti-Müllerian hormone (AMH) ≤8 pmol/L and/or antral follicle count (AFC) ≤5 on days 2-3 of the cycle. Patients from 2008 exclusively had a HS protocol treatment, while patients in 2010 had treatment with a MS protocol exclusively. The MS protocol involved letrozole at 2.5 mg over 5 days, starting from day 2, overlapping with gonadotropins, starting from the third day of letrozole at 150 units daily. GnRH antagonist was introduced once one or more follicles reached 14 mm or larger. The HS group received gonadotropins (≥300 IU/day) throughout their antagonist cycle. Clinical pregnancy rate was significantly higher in the MS protocol compared to the HS protocol (P=0.007). Furthermore, the live birth rate was significantly higher in the MS group compare to the HS group (P=0.034). In conclusion, the MS IVF protocol is less expensive (lower gonadotropin dosage) and resulted in a higher clinical pregnancy rate and live birth rate than a HS protocol for poor responders.


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