AzTrials
AzTrials

PregnancyPCOSActNCT01573858

Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome

A study testing Acupuncture treatment 1, Acupuncture treatment 2 and CC in people with Pregnancy and Polycystic Ovary Syndrome, run by Heilongjiang University of Chinese Medicine at 25 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objectives of the present trial are to test the following three hypotheses in anovulatory women with PCOS: 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. Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Pregnancy, Polycystic Ovary Syndrome, Infertility
What is being tested?
Acupuncture treatment 1, Acupuncture treatment 2 and CC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,000 participants
Where
25 sitesChina
Study dates
6 Jul 2012to 7 Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.
  • Additional exclusion criteria
  • 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.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • First Affiliated Hospital，Hunan University of Chinese Medicine

    Changsha, Hunan, 410007

  • Dalian maternity hospital

    Dalian, Liaoning, 116000

  • Daqing LongNa Hospital

    Daqing, Heilongjiang, 163000

  • The Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163000

  • First Affiliated Hospital，Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, 510000

  • Guangzhou Liwan Chinese Hospital

    Guangzhou, Guangdong, 510000

  • Guangdong Chinese Hospital

    Guangzhou, Guangdong, 510120

  • Integrated Chinese and Western Medicine Hospital of Zhejiang Province

    Hangzhou, Zhejiang, 310000

  • Hangzhou Chinese Medicine Hospital

    Hangzhou, 310000

  • Forth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Second Affiliated Hospital，Heilongjiang University of Chinese Medicine

    Harbin, Heilongjiang, 150001

  • First Affiliated Hospital，Heilongjiang University of Chinese Medicine

    Harbin, Heilongjiang, 150040

  • First Affiliated Hospital，Anhui University of Chinese Medicine

    Hefei, Anhui, 230031

  • Maternal and Child Health Hospital of Huaian

    Huaian, Jiangsu, 223002

  • Jiangxi University of Chinese Medicine Affiliated Hospital

    Nanchang, Jiangxi, 330000

  • Shanxi Chinese Medicine Hospital

    Shangxi, Shanxi, 030012

  • Liaoning University of Chinese Medicine Affiliated Hospital

    Shenyang, Liaoning, 110000

  • Suzhou Chinese Medicine Hospital

    Suzhou, Jiangsu, 215003

  • First Affiliated Hospital，Tianjin University of Chinese Medicine

    Tianjin, Tianjin Municipality, 300193

  • Tianjin Tanggu Maternity and Child Care Center

    Tianjin, Tianjin Municipality, 300451

  • Wenzhou Chinese Medicine Hospital

    Wenzhou, Zhejiang, 325000

  • Wuhan Tongji Hospital

    Wuhan, Hubei, 430000

  • Hubei Chinese Medicine Hospital

    Wuhan, Hubei, 430060

  • Maternal and Child Health Hospital of Xuzhou

    Xuzhou, Jiangsu, 221000

  • Henan Chinese Medicine Hospital

    Zhengzhou, Henan, 450002

Other trials in China

About this study

Official title: Effect of Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial (PCOSAct)

The objectives of the present trial are to test the following three hypotheses in anovulatory women with PCOS:

  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).
Read the detailed description

This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Chinese women with PCOS.

Primary outcomes:

  • Live birth rate

Secondary outcomes:

  • Ovulation rate
  • Ongoing pregnancy rate
  • Multiple pregnancy rate
  • Miscarriage rate
  • Hormonal profile
  • Metabolic profile
  • Side effect profile
Being tested
Acupuncture treatment 1, Acupuncture treatment 2, CC, CC placebo
Keywords
Infertility, Polycystic Ovary Syndrome, Clomiphene citrate, Acupuncture
Medical subject headings
Polycystic Ovary Syndrome, Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acupuncture treatment 1Other

    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 2Other

    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.

  • CCOther

    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 placeboOther

    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.

Study groups in NCT01573858
Study groupRoleWhat they receive
Acupuncture treatment 1 plus CCExperimentalNot described
Receives: Other: Acupuncture treatment 1; Other: CC
Acupuncture treatment 2 plus CCActive comparatorNot described
Receives: Other: Acupuncture treatment 2; Other: CC
Acupuncture treatment 1 plus CC placeboActive comparatorNot described
Receives: Other: Acupuncture treatment 1; Other: CC placebo
Acupucture treatment 2 and CC placebo.Active comparatorNot described
Receives: Other: Acupuncture treatment 2; Other: CC placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live birth rate

    Measured: Up to 3 years

Secondary outcomes (7)

  1. Ovulation rate

    Measured: Up to 3 years

  2. Ongoing pregnancy rate

    Up to 3 years

    Measured: Aprial 2012 to July 2014 (up to 3 years)

  3. Multiple pregnancy rate

    Measured: Up to 2 years

  4. Miscarriage rate

    loss of an intrauterine pregnancy before 20 completed weeks of gestation.

    Measured: Up to 2 years

  5. Hormonal profile

    Hormonal profile include: Testosterone(T), Sex hormone-binding globulin (SHBG), Follicle stimulating hormone (FSH),Luteinizing hormone(LH),and Dehydroepiandrosterone sulfate (DHEAS).

    Measured: Up to 2 years

  6. Metabolic profile

    Metabolic profile includes: Serum glucose concentration, Insulin concentration, cholesterol, Triglycerides (TG), High density lipoprotein cholesterol (HDL-C) and Low density lipoprotein cholesterol (LDL-C)

    Measured: Up to 2 years

  7. Side effect profile

    Side effects of CC include hot flashes, mood changes, bloating, formation of ovarian cysts, and pain, extremely rare are pituitary apoplexy and deep venous thrombosis. The major side effects of acupuncture are local skin irritation, discomfort, and vasovagal reactions during the procedure. All above mentioned side effects will be recorded weekly.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2012 (estimated)
  2. Study start6 Jul 2012
  3. Primary completion8 Nov 2014
  4. Study completion7 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01573858
Sponsor's protocol ID
PCOSAct
Acronym
PCOSAct
Status last verified
Aug 2021
First submitted
4 Apr 2012
Last updated
25 Aug 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Liu Y, Gong Y, Feng J, Ge H, Zhu M, Yu H, Gao J, Wu X. Identification of predictors of the ovarian response to clomiphene citrate in infertile women with polycystic ovary syndrome: A post-hoc analysis of a randomized controlled trial. Front Endocrinol (Lausanne). 2026 Jun 30;17:1822007. doi: 10.3389/fendo.2026.1822007. eCollection 2026.

    PubMed 42453506

  • Qin H, Shi B, Li Y, Lu F, Guan M, Yu J, Gao Z, Zhu M, Liu Y, Ge H, Wu X, Zhang Y. Comparative performance of traditional and novel adiposity indices for predicting insulin resistance and metabolic syndrome in Chinese women with polycystic ovary syndrome. Front Nutr. 2026 Jun 15;13:1835729. doi: 10.3389/fnut.2026.1835729. eCollection 2026.

    PubMed 42375770

  • Li J, Wu Q, Cong J, Chang H, Ma HL, Zhang DJ, Wang Y, Zhang RZ, Kam RKT, Ho CS, Chan MHM, Ma RCW, Ng EHY, Mol BWJ, Stener-Victorin E, Legro RS, Wang CC, Wu XK; PCOSAct Study Group. Total Testosterone Measured by Liquid Chromatograph-Tandem Mass Spectrometry Refines Diagnosis of Biochemical Hyperandrogenism and Better Identifies Subgroup at Genuine Risk of Adverse Fertility Outcomes in Women With Polycystic Ovary Syndrome. Reprod Med Biol. 2026 Jan 28;25(1):e70013. doi: 10.1002/rmb2.70013. eCollection 2026 Jan-Dec.

    PubMed 41613610

  • 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.

    PubMed 40390321

  • 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.

    PubMed 37711905

  • 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.

    PubMed 33101409

  • 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.

    PubMed 32989632

  • 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.

    PubMed 31222771

  • 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.

    PubMed 30382872

  • 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.

    PubMed 29471520

  • 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.

    PubMed 28655015

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture treatment 1, Acupuncture treatment 2 and CC in people with Pregnancy and Polycystic Ovary Syndrome, run by Heilongjiang University of Chinese Medicine at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth rate (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01573858, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in