Polycystic Ovary SyndromePhase 3NCT03625531

A Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth in Women With PCOS

A Phase 3 study testing Acupuncture and Letrozole in people with Polycystic Ovary Syndrome, run by Hongxia Ma at 1 site 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

This study is a randomized assessor-blind controlled trial. A total of 1,103 women with PCOS will be recruited from 20 hospitals and randomly allocated into four groups: personalized acupuncture, fixed acupuncture, letrozole or placebo letrozole. Read more about this study

Who is it for?: Ages 20 to 40 years, women only
Conditions the study is for: Polycystic Ovary Syndrome
What is being tested?: Acupuncture and Letrozole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,103 participants
Where: 1 siteChina
Study dates: 13 Aug 2018to 22 Jan 2025
Phase: Phase 3
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

Age of women between 20 and 40 years.
Chronic oligomenorrhea or amenorrhea: oligomenorrhea is defined as an intermenstrual interval > 35 days or < 8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days.
Hyperandrogenism (either hirsutism or hyperandrogenemia) or polycystic ovaries on ultrasound. Hirsutism is determined by a modified Ferriman-Gallwey Score ≥ 5 at screening examination, and biochemical hyperandrogenism is defined as total testosterone (T) > 2.6 nmol/L and free testosterone ≥ 6.0 pg/mL. Polycystic ovaries are present when there are ≥ 12 antral follicles (2 - 9 mm) or ovarian volume > 10 mL on transvaginal scanning.
At least one patent tube shown by hysterosalpingogram or diagnostic laparoscopy within 3 years if the patient does not have a history of abortion or pelvic operation. If the patient has a history of pregnancy and no history of pelvic operation within the past 5 years, she is not required to undergo a tubal patency test.
Sperm concentration ⩾ 15 × 106/mL and total motility ⩾ 40% or total motile sperm count ⩾ 9 million in the semen analysis of the husband. Agree to have regular intercourse i.e. 2-3 times per week during the study period.

Who cannot join

Exclusion of other endocrine disorders: a. patients with hyperprolactinemia (defined as two prolactin levels at least one week apart ≥ 25 ng/mL); b. Patients with FSH levels > 15 mIU/mL. A normal level within the last year is adequate for entry; c. 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. d. Patients diagnosed with Type I or Type II diabetes who are poorly controlled (defined as HbA1c level > 7.0%), or patients receiving antidiabetic medications such as metformin, insulin, thiazolidinediones, acarbose, or sulfonylureas. e. Patients with suspected Cushing's syndrome.
Use of other TCM treatments including Chinese herbal prescriptions and acupuncture in the past 3 months.
Use of other western medications known to affect reproductive function or metabolism in the past 2 months.
Pregnancy within the past 6 weeks.
Within 6 weeks postabortion or postpartum.
Breastfeeding within the last 6 months.

Show all 22Show fewer

Not willing to give written consent to the study.
Additional exclusion criteria are as follows.
Patients taking other medications known to affect reproductive function or metabolism. These medications include oral contraceptives, depot progestins, hormonal implants (including Implanon), GnRH agonists and antagonists, antiandrogens, gonadotropins, antiobesity drugs, antidiabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, angiotensin-converting-enzyme (ACE) inhibitors, and calcium channel blockers. The washout period on these medicationswill be two months, 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 depot 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 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 into other investigative studies that require medications, prescribe 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 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 mmHg 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

1 site in 1 country.

China1 site

The first affiliated hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: A Multicenter Randomized Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth for Infertility in Women With Polycystic Ovary Syndrome

Read the detailed description

Traditional Chinese Medicine (TCM) usually involves syndrome and disease differentiation, and for acupuncture selection of appropriate points and skillful needling techniques. Many clinical trials on acupuncture used fixed acupuncture protocols without accounting for individual differences. We here design a multicenter randomized controlled trial to evaluate whether personalized or fixed acupuncture increases the likelihood of live births for infertility in women with polycystic ovary syndrome (PCOS) compared with letrozole or placebo letrozole. We hypothesis that letrozole is more effective than personalized acupuncture and that personalized acupuncture is more effective than standardized acupuncture, which is more effective than placebo letrozole.

Conditions: Polycystic Ovary Syndrome
Being tested: Acupuncture, Letrozole, Placebo letrozole
Keywords: Acupuncture, Polycystic Ovary Syndrome, Personalized protocol, Fixed protocol, Letrozole
Medical subject headings: Polycystic Ovary Syndrome

What participants receive

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

AcupunctureOther
Women in both personalized and fixed acupuncture groups will receive acupuncture treatment three times a week. Acupuncture treatment will start on day 3 after a spontaneous period or after a withdrawal bleeding following progestin. Each treatment session will last for 30-60 minutes, with a maximum of 48 treatment sessions over 16 weeks. If they become pregnant, the acupuncture treatment will be stopped. For personalized and fixed acupuncture group, credibility and expectancy questionnaires will be completed on the third acupuncture treatment and the last acupuncture treatment.
LetrozoleDrug
Also called Femara, Novartis Pharmaceuticals
Letrozole will be started on day 3 to day 7 of the spontaneous period or a withdrawal bleeding following progestin. If there is response with ovulation, this dose will be maintained. In those with no ovulatory response, letrozole tablets of the next ovulation cycle will be take on the day 28 of the menstrual cycle and the letrozole dose will be increased to 5 mg (2 pills) a day for 5 days. If there is still no response, the dose will be increased to 7.5 mg per day for 5 days in the next cycle. The maximum daily dose of letrozole will be 7.5 mg (3 pills) daily for five days.
Placebo letrozoleDrug
Also called Placebo
Placebo letrozole will be given in the same way as letrozole. Women will receive 1 tablet a day of placebo letrozole from the day 3 to day 7 of the menstrual cycle and placebo letrozole dose will be increased 2 tablets a day in the next cycle if there is no response. The maximum daily dose of placebo letrozole will be 3 tablets daily for five days.

Study groups in NCT03625531
Study group	Role	What they receive
Personalized acupuncture	Experimental	Two sets of acupoints will be selected for the two types. The basic acupoint-prescription includes CV 4, CV 6, CV 12 and SP 6 bilaterally, ST 25 bilaterally, EX-CA 1 bilaterally, ST 40 bilaterally and SP 9 bilaterally. Additional point ST 36 bilaterally and moxibustion as adjuvant therapy will be added for the type of yang deficiency of spleen and kidney, while additional points K 13, LR 3 for the type of yin deficiency of liver and kidney. Besides, flexible modifications of 2-3 acupoints will be performed according to patients special symptoms. Receives: Other: Acupuncture
Fixed acupuncture	Experimental	Two sets of acupuncture points will be alternated every second treatment. The first set consists of CV 3, CV 6, ST 29 bilaterally, SP 6 bilaterally, SP 9 bilaterally, GV 20 and LI 4 bilaterally. The second set consists of 13 needles: ST 25 bilaterally, ST 29 bilaterally, CV 3, CV 6, SP 6 bilaterally, LR 3 bilaterally, PC 6 bilaterally and GV 20. The following points will be connected to an electrical stimulator: ST 25 bilaterally, ST 29 bilaterally, SP 6 bilaterally, LR 3 bilaterally. Receives: Other: Acupuncture
Letrozole	Active comparator	Women in the letrozole group will be given letrozole (Femara, Novartis Pharmaceuticals, Basel, Switzerland) from day 3 to day 7 of the spontaneous menstrual cycle or after a withdrawal bleeding following progestin. The maximum daily dose of letrozole will be 7.5 mg (3 pills) daily for five days. Receives: Drug: Letrozole
Placebo letrozole	Placebo comparator	Women will receive placebo letrozole with no acupuncture from day 3 to day 7 of the spontaneous menstrual cycle or after a withdrawal bleeding following progestin. Placebo letrozole will be given in the same way as letrozole. Receives: Drug: Placebo letrozole

What is being measured

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

Live birth rate
Live birth rate defined as a delivery after ≥20 weeks gestation.
Measured: Up to 14 months

Secondary outcomes (20)

Ovulation rate
Ovulation defined as a serum progesterone level >3 ng/mL on day 21 or day 28 of the cycle.
Measured: Up to 4 months
Conception rate
Conception defined as positive serum hCG.
Measured: Up to 4 months
Pregnancy rate
Around 8-10 weeks gestation.
Measured: Up to 6.5 months
Pregnancy loss rate
Pregnancy loss defined as pregnancy loss occurring from conception to 27 completed weeks of gestational age.
Measured: Up to 9 months
Follicle stimulating hormone (FSH)
Hormonal profile
Measured: Up to 4 months
Luteinizing hormone(LH)
Hormonal profile
Measured: Up to 4 months
Testosterone(T)
Hormonal profile
Measured: Up to 4 months
Sex hormone-binding globulin (SHBG)
Hormonal profile
Measured: Up to 4 months
Serum glucose concentration
Metabolic profile
Measured: Up to 4 months
Insulin concentration
Metabolic profile
Measured: Up to 4 months
Cholesterol
Metabolic profile
Measured: Up to 4 months
Triglycerides (TG)
Metabolic profile
Measured: Up to 4 months
High density lipoprotein cholesterol (HDL-C)
Metabolic profile
Measured: Up to 4 months
Low density lipoprotein cholesterol (LDL-C)
Metabolic profile
Measured: Up to 4 months
The scores of short form 36 (SF 36)
SF-36 is one of questionnaires for assessments of health-related quality of life. It includes 36 items, the scores for each domain range from 0 to 100, with high scores indicating a better status.
Measured: Up to 4 months
The scores of polycystic ovary syndrome questionnaire (PCOSQ)
PCOSQ is one of questionnaires for assessments of health-related quality of life. It concludes 26 items. Each question is associated with a 7-point scale in which 7 represents optimal function and 1 represents the poorest function.
Measured: Up to 4 months
The scores of Chinese quality of life (ChQOL) questionnaire
ChQOL is one of questionnaires for assessments of health-related quality of life. The ChQOL is unique in that it is a health-related quality of life （HRQOL） measure specific to Traditional Chinese Medicine (TCM). ChQOL consists of 50 items ,each item is rated on a five-point Likert scale with higher scores indicating better HRQOL.
Measured: Up to 4 months
The scores of Zung Self-Rating Anxiety Scale (SAS)
Zung SAS is one of questionnaires for symptoms of anxiety and depression. For the SAS, index score of 50 is a cut-off point for clinically significant anxiety, with higher score suggesting more serious depression.
Measured: Up to 4 months
The scores of Zung Self-reported Depression Scale (SDS)
Zung SDS is one of questionnaires for symptoms of anxiety and depression. Index scores of 25 to 49 indicate nil depression, 50-59 indicate mild to moderate depression, 60-69 indicate moderate to severe depression, and scores over 70 indicate severe depression.
Measured: Up to 4 months
Side effect profile
Adverse events will be categorized and percentage of patients experiencing. adverse events and serious adverse events during the treatment period will be documented.
Measured: Up to 14 months

Timeline

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

13 Aug 201822 Jan 2025

First posted10 Aug 2018
Study start13 Aug 2018
Primary completion22 Jan 2025
Study completion22 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03625531
Sponsor's protocol ID: PPCOSAct
Status last verified: Apr 2026
First submitted: 13 Jul 2018
Last updated: 14 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Homburg R. Management of infertility and prevention of ovarian hyperstimulation in women with polycystic ovary syndrome. Best Pract Res Clin Obstet Gynaecol. 2004 Oct;18(5):773-88. doi: 10.1016/j.bpobgyn.2004.05.006.
PubMed 15380146
Thessaloniki ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Consensus on infertility treatment related to polycystic ovary syndrome. Hum Reprod. 2008 Mar;23(3):462-77. doi: 10.1093/humrep/dem426.
PubMed 18308833
Legro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, Steinkampf MP, Coutifaris C, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Giudice LC, Leppert PC, Myers ER; Cooperative Multicenter Reproductive Medicine Network. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med. 2007 Feb 8;356(6):551-66. doi: 10.1056/NEJMoa063971.
PubMed 17287476
Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.
PubMed 16595197
Franik S, Kremer JA, Nelen WL, Farquhar C, Marjoribanks J. Aromatase inhibitors for subfertile women with polycystic ovary syndrome: summary of a Cochrane review. Fertil Steril. 2015 Feb;103(2):353-5. doi: 10.1016/j.fertnstert.2014.10.016. Epub 2014 Nov 5.
PubMed 25455536
Balen AH, Morley LC, Misso M, Franks S, Legro RS, Wijeyaratne CN, Stener-Victorin E, Fauser BC, Norman RJ, Teede H. The management of anovulatory infertility in women with polycystic ovary syndrome: an analysis of the evidence to support the development of global WHO guidance. Hum Reprod Update. 2016 Nov;22(6):687-708. doi: 10.1093/humupd/dmw025. Epub 2016 Aug 10.
PubMed 27511809
Jedel E, Labrie F, Oden A, Holm G, Nilsson L, Janson PO, Lind AK, Ohlsson C, Stener-Victorin E. Impact of electro-acupuncture and physical exercise on hyperandrogenism and oligo/amenorrhea in women with polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E37-45. doi: 10.1152/ajpendo.00495.2010. Epub 2010 Oct 13.
PubMed 20943753
Johansson J, Redman L, Veldhuis PP, Sazonova A, Labrie F, Holm G, Johannsson G, Stener-Victorin E. Acupuncture for ovulation induction in polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2013 May 1;304(9):E934-43. doi: 10.1152/ajpendo.00039.2013. Epub 2013 Mar 12.
PubMed 23482444
Benrick A, Kokosar M, Hu M, Larsson M, Maliqueo M, Marcondes RR, Soligo M, Protto V, Jerlhag E, Sazonova A, Behre CJ, Hojlund K, Thoren P, Stener-Victorin E. Autonomic nervous system activation mediates the increase in whole-body glucose uptake in response to electroacupuncture. FASEB J. 2017 Aug;31(8):3288-3297. doi: 10.1096/fj.201601381R. Epub 2017 Apr 12.
PubMed 28404742
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
Napadow V, Kaptchuk TJ. Patient characteristics for outpatient acupuncture in Beijing, China. J Altern Complement Med. 2004 Jun;10(3):565-72. doi: 10.1089/1075553041323849.
PubMed 15253864
Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005 May 4;293(17):2118-25. doi: 10.1001/jama.293.17.2118.
PubMed 15870415
Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009 May 11;169(9):858-66. doi: 10.1001/archinternmed.2009.65.
PubMed 19433697
Macklin EA, Wayne PM, Kalish LA, Valaskatgis P, Thompson J, Pian-Smith MC, Zhang Q, Stevens S, Goertz C, Prineas RJ, Buczynski B, Zusman RM. Stop Hypertension with the Acupuncture Research Program (SHARP): results of a randomized, controlled clinical trial. Hypertension. 2006 Nov;48(5):838-45. doi: 10.1161/01.HYP.0000241090.28070.4c. Epub 2006 Oct 2.
PubMed 17015784
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
PubMed 20332511

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Polycystic Ovary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Randomized Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth for Infertility in Women With Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT03625531
Acronym / sponsor ID: PPCOSAct
Conditions: Polycystic Ovary Syndrome
Keywords: Acupuncture, Polycystic Ovary Syndrome, Personalized protocol, Fixed protocol, Letrozole
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,103 participants (actual)
Lead sponsor: Hongxia MaUniversity, hospital or other
Study start: 13 Aug 2018 (actual)
Primary completion: 22 Jan 2025 (actual)
Study completion: 22 Jan 2025 (actual)
First posted: 10 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Personalized acupuncture	Experimental	Other: AcupunctureTwo sets of acupoints will be selected for the two types. The basic acupoint-prescription includes CV 4, CV 6, CV 12 and SP 6 bilaterally, ST 25 bilaterally, EX-CA 1 bilaterally, ST 40 bilaterally and SP 9 bilaterally. Additional point ST 36 bilaterally and moxibustion as adjuvant therapy will be added for the type of yang deficiency of spleen and kidney, while additional points K 13, LR 3 for the type of yin deficiency of liver and kidney. Besides, flexible modifications of 2-3 acupoints will be performed according to patients special symptoms.
Fixed acupuncture	Experimental	Other: AcupunctureTwo sets of acupuncture points will be alternated every second treatment. The first set consists of CV 3, CV 6, ST 29 bilaterally, SP 6 bilaterally, SP 9 bilaterally, GV 20 and LI 4 bilaterally. The second set consists of 13 needles: ST 25 bilaterally, ST 29 bilaterally, CV 3, CV 6, SP 6 bilaterally, LR 3 bilaterally, PC 6 bilaterally and GV 20. The following points will be connected to an electrical stimulator: ST 25 bilaterally, ST 29 bilaterally, SP 6 bilaterally, LR 3 bilaterally.
Letrozole	Active comparator	Drug: LetrozoleWomen in the letrozole group will be given letrozole (Femara, Novartis Pharmaceuticals, Basel, Switzerland) from day 3 to day 7 of the spontaneous menstrual cycle or after a withdrawal bleeding following progestin. The maximum daily dose of letrozole will be 7.5 mg (3 pills) daily for five days.
Placebo letrozole	Placebo comparator	Drug: Placebo letrozoleWomen will receive placebo letrozole with no acupuncture from day 3 to day 7 of the spontaneous menstrual cycle or after a withdrawal bleeding following progestin. Placebo letrozole will be given in the same way as letrozole.

Who may qualify

Ages: 20 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Age of women between 20 and 40 years.
Chronic oligomenorrhea or amenorrhea: oligomenorrhea is defined as an intermenstrual interval > 35 days or < 8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days.
Hyperandrogenism (either hirsutism or hyperandrogenemia) or polycystic ovaries on ultrasound. Hirsutism is determined by a modified Ferriman-Gallwey Score ≥ 5 at screening examination, and biochemical hyperandrogenism is defined as total testosterone (T) > 2.6 nmol/L and free testosterone ≥ 6.0 pg/mL. Polycystic ovaries are present when there are ≥ 12 antral follicles (2 - 9 mm) or ovarian volume > 10 mL on transvaginal scanning.
At least one patent tube shown by hysterosalpingogram or diagnostic laparoscopy within 3 years if the patient does not have a history of abortion or pelvic operation. If the patient has a history of pregnancy and no history of pelvic operation within the past 5 years, she is not required to undergo a tubal patency test.
Sperm concentration ⩾ 15 × 106/mL and total motility ⩾ 40% or total motile sperm count ⩾ 9 million in the semen analysis of the husband. Agree to have regular intercourse i.e. 2-3 times per week during the study period.

Key exclusion criteria (22 listed)

Exclusion of other endocrine disorders: a. patients with hyperprolactinemia (defined as two prolactin levels at least one week apart ≥ 25 ng/mL); b. Patients with FSH levels > 15 mIU/mL. A normal level within the last year is adequate for entry; c. 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. d. Patients diagnosed with Type I or Type II diabetes who are poorly controlled (defined as HbA1c level > 7.0%), or patients receiving antidiabetic medications such as metformin, insulin, thiazolidinediones, acarbose, or sulfonylureas. e. Patients with suspected Cushing's syndrome.
Use of other TCM treatments including Chinese herbal prescriptions and acupuncture in the past 3 months.
Use of other western medications known to affect reproductive function or metabolism in the past 2 months.
Pregnancy within the past 6 weeks.
Within 6 weeks postabortion or postpartum.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcupunctureWomen in both personalized and fixed acupuncture groups will receive acupuncture treatment three times a week. Acupuncture treatment will start on day 3 after a spontaneous period or after a withdrawal bleeding following progestin. Each treatment session will last for 30-60 minutes, with a maximum of 48 treatment sessions over 16 weeks. If they become pregnant, the acupuncture treatment will be stopped. For personalized and fixed acupuncture group, credibility and expectancy questionnaires will be completed on the third acupuncture treatment and the last acupuncture treatment.	Other	Fixed acupuncture, Personalized acupuncture
LetrozoleAlso: Femara, Novartis PharmaceuticalsLetrozole will be started on day 3 to day 7 of the spontaneous period or a withdrawal bleeding following progestin. If there is response with ovulation, this dose will be maintained. In those with no ovulatory response, letrozole tablets of the next ovulation cycle will be take on the day 28 of the menstrual cycle and the letrozole dose will be increased to 5 mg (2 pills) a day for 5 days. If there is still no response, the dose will be increased to 7.5 mg per day for 5 days in the next cycle. The maximum daily dose of letrozole will be 7.5 mg (3 pills) daily for five days.	Drug	Letrozole
Placebo letrozoleAlso: PlaceboPlacebo letrozole will be given in the same way as letrozole. Women will receive 1 tablet a day of placebo letrozole from the day 3 to day 7 of the menstrual cycle and placebo letrozole dose will be increased 2 tablets a day in the next cycle if there is no response. The maximum daily dose of placebo letrozole will be 3 tablets daily for five days.	Drug	Placebo letrozole

Primary outcome

Live birth rate
Time frame: Up to 14 months
Live birth rate defined as a delivery after ≥20 weeks gestation.

20 secondary outcomes

Ovulation rate
Time frame: Up to 4 months
Conception rate
Time frame: Up to 4 months
Pregnancy rate
Time frame: Up to 6.5 months
Pregnancy loss rate
Time frame: Up to 9 months
Follicle stimulating hormone (FSH)
Time frame: Up to 4 months
Luteinizing hormone(LH)
Time frame: Up to 4 months
Testosterone(T)
Time frame: Up to 4 months
Sex hormone-binding globulin (SHBG)
Time frame: Up to 4 months
Serum glucose concentration
Time frame: Up to 4 months
Insulin concentration
Time frame: Up to 4 months
Cholesterol
Time frame: Up to 4 months
Triglycerides (TG)
Time frame: Up to 4 months
High density lipoprotein cholesterol (HDL-C)
Time frame: Up to 4 months
Low density lipoprotein cholesterol (LDL-C)
Time frame: Up to 4 months
The scores of short form 36 (SF 36)
Time frame: Up to 4 months
The scores of polycystic ovary syndrome questionnaire (PCOSQ)
Time frame: Up to 4 months
The scores of Chinese quality of life (ChQOL) questionnaire
Time frame: Up to 4 months
The scores of Zung Self-Rating Anxiety Scale (SAS)
Time frame: Up to 4 months
The scores of Zung Self-reported Depression Scale (SDS)
Time frame: Up to 4 months
Side effect profile
Time frame: Up to 14 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Background: PubMed 15380146Homburg R. Management of infertility and prevention of ovarian hyperstimulation in women with polycystic ovary syndrome. Best Pract Res Clin Obstet Gynaecol. 2004 Oct;18(5):773-88. doi: 10.1016/j.bpobgyn.2004.05.006.
Background: PubMed 18308833Thessaloniki ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Consensus on infertility treatment related to polycystic ovary syndrome. Hum Reprod. 2008 Mar;23(3):462-77. doi: 10.1093/humrep/dem426.
Background: PubMed 17287476Legro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, Steinkampf MP, Coutifaris C, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Giudice LC, Leppert PC, Myers ER; Cooperative Multicenter Reproductive Medicine Network. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med. 2007 Feb 8;356(6):551-66. doi: 10.1056/NEJMoa063971.
Background: PubMed 16595197Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.
Background: PubMed 25455536Franik S, Kremer JA, Nelen WL, Farquhar C, Marjoribanks J. Aromatase inhibitors for subfertile women with polycystic ovary syndrome: summary of a Cochrane review. Fertil Steril. 2015 Feb;103(2):353-5. doi: 10.1016/j.fertnstert.2014.10.016. Epub 2014 Nov 5.
Background: PubMed 27511809Balen AH, Morley LC, Misso M, Franks S, Legro RS, Wijeyaratne CN, Stener-Victorin E, Fauser BC, Norman RJ, Teede H. The management of anovulatory infertility in women with polycystic ovary syndrome: an analysis of the evidence to support the development of global WHO guidance. Hum Reprod Update. 2016 Nov;22(6):687-708. doi: 10.1093/humupd/dmw025. Epub 2016 Aug 10.
Background: PubMed 20943753Jedel E, Labrie F, Oden A, Holm G, Nilsson L, Janson PO, Lind AK, Ohlsson C, Stener-Victorin E. Impact of electro-acupuncture and physical exercise on hyperandrogenism and oligo/amenorrhea in women with polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E37-45. doi: 10.1152/ajpendo.00495.2010. Epub 2010 Oct 13.
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Background: PubMed 28655015Wu 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.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hongxia HX Ma, Dorctor study chair

The First Affiliated Hospital of Guangzhou Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acupuncture and Letrozole in people with Polycystic Ovary Syndrome, run by Hongxia Ma at 1 site 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 5 inclusion and 22 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 14 months). 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 NCT03625531, which also lists 23 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 14 Apr 2026.