NCT04987632

Effect of Acupuncture Plus Governor Vessel Moxibustion Combined With Letrozole on Live Birth in Anovulatory Infertile Women With Spleen-kidney Yang Deficiency PCOS

Effect of Acupuncture Plus Governor Vessel Moxibustion Combined With Letrozole on Live Birth in Anovulatory Infertile Women With Spleen-kidney Yang Deficiency Polycystic Ovary Syndrome: a Randomised Controlled Trial

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Qiu-ping Lin · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Investigators expected to verify this hypothesis through this study:acupuncture and moxibustion combined with LE induced ovulation in Chinese anovulatory PCOS women has a higher rate of live birth than LE induced ovulation alone.

Detailed description

It is a prospective, single center, clinical, randomized, controlled study. The subjects were 90 PCOS anovulatory participants of spleen kidney yang deficiency type, aged 20-40 years, who were treated in the outpatient department of Obstetrics and Gynecology of Dongguan Hospital of traditional Chinese medicine from January 2021 to December 2022. Participants were randomly divided into two groups: Acupuncture plus Du Meridian moxibustion combined with LE ovulation induction treatment group and single Le ovulation induction control group, 45 cases in each group. The subjects in the two groups began to take letrozole or combined with acupuncture and Du Meridian moxibustion on 3-5 days of menstruation (spontaneous menstruation or progesterone withdrawal bleeding). If not pregnant, the subjects received letrozole for up to 4 cycles to induce ovulation or acupuncture plus Du Meridian moxibustion. Once pregnancy is found, acupuncture and Du Meridian moxibustion or drug treatment will stop immediately. At the end of treatment, data were collected to observe the differences of live birth rate, pregnancy rate, ovulation rate, sex hormone, steroid hormone, glucose and lipid metabolism index and safety index between the two groups.

Conditions

• PCOS
• Infertility, Female

Interventions

Type	Name	Description
DRUG	Letrozole	Letrozole, an aromatase inhibitor, is considered to be the first-line drug for ovulation induction in PCOS.
DEVICE	acupuncture	Domestic and foreign studies suggest that acupuncture and electroacupuncture can improve the menstrual cycle of PCOS and reduce the level of total testosterone; Acupuncture can regulate glucose homeostasis by stimulating the autonomic nervous system of PCOS patients. Our previous studies and a large number of literatures have proved that acupuncture can improve insulin resistance in PCOS, and acupuncture can improve the pregnancy rate in PCOS.
OTHER	Governor vessel moxibustion	It can warm the kidney, promote digestion and absorption, remove dampness and promote blood circulation

Timeline

• Start date: 2021-08-03
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-08-03
• Last updated: 2021-08-03