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

NCT ID: NCT04987632

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-03
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Letrozole combined with acupuncture and Du Meridian moxibustion group

Letrozole combined with acupuncture and Du Meridian moxibustion was taken from 3-5 days of menstrual period (spontaneous menstruation or progesterone withdrawal bleeding). The acupuncture treatment was 3 times / week, with an interval of 2-4 days, 12 times a week, 30 minutes each time; Du Meridian moxibustion is 20 minutes each time, once a week, four times a week. The initial dose of letrozole was 2.5mg/day for 5 consecutive days. The follow-up dose was determined according to the response of the subjects to the initial dose, with one month as a cycle. If not pregnant, the subjects received letrozole for up to 4 cycles to induce ovulation with acupuncture plus Du Meridian moxibustion.

Group Type: EXPERIMENTAL

Letrozole

Intervention Type: DRUG

Letrozole, an aromatase inhibitor, is considered to be the first-line drug for ovulation induction in PCOS.

acupuncture

Intervention Type: DEVICE

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.

Governor vessel moxibustion

Intervention Type: OTHER

It can warm the kidney, promote digestion and absorption, remove dampness and promote blood circulation

Letrozole group

Letrozole was taken 3-5 days after menstruation (spontaneous menstruation or progesterone withdrawal bleeding). The initial dose of letrozole was 2.5mg/day for 5 consecutive days. The follow-up dose was determined according to the response of the subjects to the initial dose, with one month as a cycle. In the absence of pregnancy, subjects were treated with letrozole for up to four cycles.

Group Type: ACTIVE_COMPARATOR

Letrozole

Intervention Type: DRUG

Letrozole, an aromatase inhibitor, is considered to be the first-line drug for ovulation induction in PCOS.

Interventions

Letrozole

Letrozole, an aromatase inhibitor, is considered to be the first-line drug for ovulation induction in PCOS.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Governor vessel moxibustion

It can warm the kidney, promote digestion and absorption, remove dampness and promote blood circulation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women between the ages of 20 and 40.
• It meets the diagnostic criteria of spleen-kidney Yang deficiency type PCOS.
• According to World Health Organization standards (2010), the husband's semen analysis meets ① or ②.①Sperm density ≥15×10^6/ml, and motile sperm (forward and non-forward) ≥40% (A + B + C ≥40%)).② Total motile sperm number ≥9 million.That is, the percentage of semen volume × semen density × motility sperm ≥9×10^6.
• Tubal patency tests, including hysterosalpingography and diagnostic laparoscopy, which show that at least one fallopian tube is open.(If there is no history of pelvic operation or abortion, patency test results are effective within 3 years;If there is a history of fertility within 5 years and there is no pelvic operation, the tubal patency test is not required).
• Agree to discontinue the use of other therapies during the study. 6) Participate in the study voluntarily and sign the informed consent.

Exclusion Criteria

• Eliminate other endocrine disorders: ① Patients with hyperprolactinemia (defined as two prolactin levels greater than or equal to 25ng/ml or determined by local standard values at least one week apart).The goal of excluding patients with hyperprolactinemia was to reduce variability among PCOS patients.These patients may be treated with alternative therapies (e.g., dopamine agonists).Those who had received treatment within the past year or were receiving treatment with normal test values could be enrolled. ② Menopausal FSH level (> 15 mIU/mL).Normal levels in the past year are eligible for inclusion. ③ Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or >5.5 mIU/mL).In the past year, normal levels can be included in the group. ④ Patients with poorly controlled type I or II diabetes (defined as a bb0 7.0% glycosylated hemoglobin level) or patients receiving antidiabetic drugs such as insulin, thiazole-lowering drugs, acarbose, or sulfonylureas may obfuscate the effects of the study drugs;Patients who were being treated with metformin in order to be diagnosed with type I or II diabetes or PCOS also need to be excluded. ⑤ Suspected patients with Cushing syndrome.
• In the last 2 months, use of hormones or other drugs, including TCM prescriptions and Chinese patent medicines, may affect the results.
• Pregnancy history within the last 6 weeks.
• A history of miscarriage or birth in the last 6 weeks.
• A history of breastfeeding in the last 6 months.
• Do not agree to sign the informed consent for this study.
• PCOS women who do not belong to the syndrome of spleen-kidney Yang deficiency.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Qiu-ping Lin

OTHER

Sponsor Role: lead

Responsible Party

Qiu-ping Lin

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

naiping wang, Chief physician

Role: STUDY_DIRECTOR

Dongguan Hospital of Traditional Chinese Medicine

Central Contacts

kewei Quan, attending doctor

Role: CONTACT

279271961@qq.com

0086 13416820860

Qiuping Lin, no

Role: CONTACT

2758063750@qq.com

0086 15014165537

Other Identifiers

20211408

Identifier Type: -

Identifier Source: org_study_id