Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome
NCT ID: NCT01573858
Last Updated: 2021-08-25
Study Results
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Basic Information
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COMPLETED
NA
1000 participants
INTERVENTIONAL
2012-07-06
2015-10-07
Brief Summary
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1. Acupuncture protocol 1 plus CC (Arm A) is more likely to result in live birth than acupuncture protocol 2 combined with CC (Arm B),
2. Acupuncture protocol 2 plus CC (Arm B) is more likely to result in live birth than acupuncture protocol 1 plus placebo (Arm C),
3. Acupuncture protocol 1 plus placebo (Arm C) is more likely to result in live birth than acupuncture protocol 2 plus placebo (Arm D).
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Detailed Description
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Primary outcomes:
\- Live birth rate
Secondary outcomes:
* Ovulation rate
* Ongoing pregnancy rate
* Multiple pregnancy rate
* Miscarriage rate
* Hormonal profile
* Metabolic profile
* Side effect profile
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acupuncture treatment 1 plus CC
Acupuncture treatment 1
Two sets of acupuncture points will be alternated every second treatment. The first set consists of CV3, CV 6, and ST 29 bilaterally，SP 6 and SP 9 bilaterally. Needles will also be placed in LI bilaterally and GV 20. CV 3, CV 6, ST 29, SP 6, and SP 9 will be connected to and electrical stimulator and stimulated with low-frequency EA of 2Hz, 0.3 ms.
CC
CC 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.
Acupuncture treatment 2 plus CC
Acupuncture treatment 2
Needles will be inserted to a depth of \<5 mm, one in each shoulder and on in each upper arm at non-acupuncture points. Electrodes will be attached to the needles and the stimulator will be turned on at an intensity of zero (no active current) in order to mimic EA in the acupuncture treatment 1. No manual stimulation of the needles will be performed.
CC
CC 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.
Acupuncture treatment 1 plus CC placebo
Acupuncture treatment 1
Two sets of acupuncture points will be alternated every second treatment. The first set consists of CV3, CV 6, and ST 29 bilaterally，SP 6 and SP 9 bilaterally. Needles will also be placed in LI bilaterally and GV 20. CV 3, CV 6, ST 29, SP 6, and SP 9 will be connected to and electrical stimulator and stimulated with low-frequency EA of 2Hz, 0.3 ms.
CC placebo
CC placebo 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC Placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.
Acupucture treatment 2 and CC placebo.
Acupuncture treatment 2
Needles will be inserted to a depth of \<5 mm, one in each shoulder and on in each upper arm at non-acupuncture points. Electrodes will be attached to the needles and the stimulator will be turned on at an intensity of zero (no active current) in order to mimic EA in the acupuncture treatment 1. No manual stimulation of the needles will be performed.
CC placebo
CC placebo 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC Placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.
Interventions
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Acupuncture treatment 1
Two sets of acupuncture points will be alternated every second treatment. The first set consists of CV3, CV 6, and ST 29 bilaterally，SP 6 and SP 9 bilaterally. Needles will also be placed in LI bilaterally and GV 20. CV 3, CV 6, ST 29, SP 6, and SP 9 will be connected to and electrical stimulator and stimulated with low-frequency EA of 2Hz, 0.3 ms.
Acupuncture treatment 2
Needles will be inserted to a depth of \<5 mm, one in each shoulder and on in each upper arm at non-acupuncture points. Electrodes will be attached to the needles and the stimulator will be turned on at an intensity of zero (no active current) in order to mimic EA in the acupuncture treatment 1. No manual stimulation of the needles will be performed.
CC
CC 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.
CC placebo
CC placebo 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC Placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandro-genism.
* Patency of at least one tube and a normal uterine cavity shown by hysterosalpingogram, HyCosi or diagnostic laparoscopy.
* Semen analysis:
1. a. Sperm concentration ≥15×106/ml and b. total motility (a+b+c) ≥40% or forward motility (a+b) ≥32% in the semen analysis of the husband (based on World Health Organization, 2010).
2. Total motile sperm count ≥9 million \[based on WHO (2010) criteria, volume 1.5 ml; conc 15 million; motility 40%. 1.5 x 15 x 0.04=9 million\].
Exclusion Criteria
* Patients with hyperprolactinemia (defined as two prolactin levels at least one week apart 25 ng/mL or greater or as determined by local normative values). The goal of eliminating patients with documented hyperprolactinemia is to decrease the heterogeneity of the PCOS population. These patients may be candidates for ovulation induction with alternate regimens (dopamine agonists). A normal level within the last year or on treatment is adequate for entry.
* Patients with FSH levels \> 15 mIU/mL. A normal level within the last year is adequate for entry.
* Patients with uncorrected thyroid disease (defined as TSH \< 0.2 mIU/mL or \> 5.5 mIU/mL). A normal level within the last year is adequate for entry.
* Patients diagnosed with Type I or Type II diabetes who are poorly controlled (defined as a glycohemoglobin level \> 7.0%), or patients receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; patients currently receiving metformin XR for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded.
* Patients with suspected Cushing's syndrome.
* Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome at least in the past 2 months.
* Pregnancy within the past 6 weeks.
* Within 6 weeks post-abortion or postpartum.
* Breastfeeding within the last 6 months.
* Acupuncture within the last 6 months.
* Not willing to give written consent to the study.
* Patients on oral contraceptives, depot progestins, or hormonal implants (including Implanon). A two month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants, especially where the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins.
* Patients with liver disease defined as AST or ALT \> 2 times normal or total bilirubin \>2.5 mg/dL. Patients with renal disease defined as BUN \> 30 mg/dL or serum creatinine\> 1.4 mg/dL.
* Patients with significant anemia (Hemoglobin \< 10 g/dL).
* Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident.
* Patients with known heart disease that is likely to be exacerbated by pregnancy.
* Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma. A normal Pap smear result will be required for women 21 and over.
* Patients with a current history of alcohol abuse. Alcohol abuse is defined as \> 14 drinks/week or binge drinking.
* Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol.
* Patients who anticipate taking longer than a one month break during the protocol should not be enrolled.
* Patients taking other medications known to affect reproductive function or metabolism. These medications include oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs, Chinese herbal formula, anti-diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, ACE inhibitors, and calcium channel blockers. The washout period on all these medications will be two months.
* Patients with a suspected adrenal or ovarian tumor secreting androgens.
* Couples with previous sterilization procedures (vasectomy, tubal ligation) which have been reversed. The prior procedure may affect study outcomes, and patients with both a reversed sterilization procedure and PCOS are rare enough that exclusion should not adversely affect recruitment.
* Subjects who have undergone a bariatric surgery procedure in the recent past (\< 12 months) and are in a period of acute weight loss or have been advised against pregnancy by their bariatric surgeon.
* Patients with untreated poorly controlled hypertension defined as a systolic blood pressure 160 mm Hg or a diastolic 100 mm Hg obtained on two measures obtained at least 60 minutes apart.
* Patients with known congenital adrenal hyperplasia.
20 Years
40 Years
FEMALE
No
Sponsors
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Yale University
OTHER
Penn State University
OTHER
Göteborg University
OTHER
The University of Hong Kong
OTHER
Beijing University of Chinese Medicine
OTHER
Sichuan University
OTHER
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
OTHER
Harbin Medical University
OTHER
Daqing Oil Field Hospital
OTHER
Daqing Longnan Hospital
UNKNOWN
Liaoning University of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
OTHER
Tianjin Tanggu Maternity and Child Care Center
UNKNOWN
Wenzhou Chinese Medicine Hospital
UNKNOWN
Jiangsu Province Hospital of Traditional Chinese Medicine
OTHER
Hangzhou Chinese Medicine Hospital
UNKNOWN
Shanxi Chinese Medicine Hospital
UNKNOWN
Henan Chinese Medicine Hospital
UNKNOWN
Maternal and Child Health Hospital of Xuzhou
UNKNOWN
Huaian Maternal and Child Health Care Hospital
OTHER
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
OTHER
Suzhou Chinese Medicine Hospital
UNKNOWN
Wuhan TongJi Hospital
OTHER
Hubei Chinese Medicine Hospital
UNKNOWN
Jiangxi University of Chinese Medicine Affiliated Hospital
UNKNOWN
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
OTHER
Guangdong Provincial People's Hospital
OTHER
Guangzhou Liwan Chinese Hospital
UNKNOWN
Dalian maternity hospital
UNKNOWN
Heilongjiang University of Chinese Medicine
OTHER
Responsible Party
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Xiaoke Wu
Professor and Department Chairman of Obstetrics and Gynecology
Principal Investigators
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Xiaoke Wu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Lihui Hou, M.D.
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Richard Legro, MD
Role: STUDY_CHAIR
Steering Committee, Pennsylvania State University College of Medicine
Heping Zhang, PHD
Role: STUDY_CHAIR
Data and Quality Control, Yale University
Locations
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First Affiliated Hospital，Anhui University of Chinese Medicine
Hefei, Anhui, China
First Affiliated Hospital，Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Guangzhou Liwan Chinese Hospital
Guangzhou, Guangdong, China
Guangdong Chinese Hospital
Guangzhou, Guangdong, China
Daqing LongNa Hospital
Daqing, Heilongjiang, China
The Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Forth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Second Affiliated Hospital，Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China
First Affiliated Hospital，Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China
Henan Chinese Medicine Hospital
Zhengzhou, Henan, China
Wuhan Tongji Hospital
Wuhan, Hubei, China
Hubei Chinese Medicine Hospital
Wuhan, Hubei, China
First Affiliated Hospital，Hunan University of Chinese Medicine
Changsha, Hunan, China
Maternal and Child Health Hospital of Huaian
Huaian, Jiangsu, China
Suzhou Chinese Medicine Hospital
Suzhou, Jiangsu, China
Maternal and Child Health Hospital of Xuzhou
Xuzhou, Jiangsu, China
Jiangxi University of Chinese Medicine Affiliated Hospital
Nanchang, Jiangxi, China
Dalian maternity hospital
Dalian, Liaoning, China
Liaoning University of Chinese Medicine Affiliated Hospital
Shenyang, Liaoning, China
Shanxi Chinese Medicine Hospital
Shangxi, Shanxi, China
First Affiliated Hospital，Tianjin University of Chinese Medicine
Tianjin, Tianjin Municipality, China
Tianjin Tanggu Maternity and Child Care Center
Tianjin, Tianjin Municipality, China
Integrated Chinese and Western Medicine Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Wenzhou Chinese Medicine Hospital
Wenzhou, Zhejiang, China
Hangzhou Chinese Medicine Hospital
Hangzhou, , China
Countries
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References
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Gong Y, Li J, Ma HL, Jiang T, Qin HC, Li MB, Wu XK. High acupuncture expectancy is associated with shorter time to ovulation and higher chances of ovulation in infertile patients with PCOS receiving acupuncture: a secondary analysis of a randomized controlled trial. Acupunct Med. 2025 Jun;43(3):137-143. doi: 10.1177/09645284251342261. Epub 2025 May 19.
Chang H, Shi B, Ge H, Liu C, Wang L, Ma C, Liu L, Zhang W, Zhang D, Wang Y, Wang CC, Wu X. Acupuncture improves the emotion domain and lipid profiles in women with polycystic ovarian syndrome: a secondary analysis of a randomized clinical trial. Front Endocrinol (Lausanne). 2023 Aug 29;14:1237260. doi: 10.3389/fendo.2023.1237260. eCollection 2023.
Luo X, Yang XM, Cai WY, Chang H, Ma HL, Peng Y, Wu XK. Decreased Sex Hormone-Binding Globulin Indicated Worse Biometric, Lipid, Liver, and Renal Function Parameters in Women with Polycystic Ovary Syndrome. Int J Endocrinol. 2020 Jun 25;2020:7580218. doi: 10.1155/2020/7580218. eCollection 2020.
Zhang D, Gao J, Liu X, Qin H, Wu X. Effect of Three Androgen Indexes (FAI, FT, and TT) on Clinical, Biochemical, and Fertility Outcomes in Women with Polycystic Ovary Syndrome. Reprod Sci. 2021 Mar;28(3):775-784. doi: 10.1007/s43032-020-00316-1. Epub 2020 Sep 28.
Zhang D, Yang X, Li J, Yu J, Wu X. Effect of hyperinsulinaemia and insulin resistance on endocrine, metabolic and fertility outcomes in women with polycystic ovary syndrome undergoing ovulation induction. Clin Endocrinol (Oxf). 2019 Sep;91(3):440-448. doi: 10.1111/cen.14050. Epub 2019 Jun 28.
Ma HL, Xie LZ, Gao JS, Cong J, Deng YY, Ng EHY, Liu JP, Wu XK. Acupuncture and clomiphene for Chinese women with polycystic ovary syndrome (PCOSAct): statistical analysis approach with the revision and explanation. Trials. 2018 Nov 1;19(1):601. doi: 10.1186/s13063-018-2942-7.
Li J, Wu Q, Wu XK, Zhou ZM, Fu P, Chen XH, Yan Y, Wang X, Yang ZW, Li WL, Stener-Victorin E, Legro RS, Ng EH, Zhang H, Mol BWJ, Wang CC; for PCOSAct Study Group. Effect of exposure to second-hand smoke from husbands on biochemical hyperandrogenism, metabolic syndrome and conception rates in women with polycystic ovary syndrome undergoing ovulation induction. Hum Reprod. 2018 Apr 1;33(4):617-625. doi: 10.1093/humrep/dey027.
Wu XK, Stener-Victorin E, Kuang HY, Ma HL, Gao JS, Xie LZ, Hou LH, Hu ZX, Shao XG, Ge J, Zhang JF, Xue HY, Xu XF, Liang RN, Ma HX, Yang HW, Li WL, Huang DM, Sun Y, Hao CF, Du SM, Yang ZW, Wang X, Yan Y, Chen XH, Fu P, Ding CF, Gao YQ, Zhou ZM, Wang CC, Wu TX, Liu JP, Ng EHY, Legro RS, Zhang H; PCOSAct Study Group. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2502-2514. doi: 10.1001/jama.2017.7217.
Other Identifiers
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PCOSAct
Identifier Type: -
Identifier Source: org_study_id
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