Effect of Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial (PCOSAct)
- Age of women between 20 and 40 years.
- Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all
subjects must have anovulation plus either polycystic ovaries and/or
- 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].
2. Exclusion Criteria:
- Exclusion of other endocrine disorders
- 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.
- 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
- Patients with known heart disease that is likely to be exacerbated by
- 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
- 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.