NCT01573858: PCOSAct

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

Completed NA Last updated 25 August 2021

What this trial tests

NA trial testing Acupuncture treatment 1 in Pregnancy in 1,000 participants. Completed in 7 October 2015.

Timeline

6 July 2012

Primary endpoint
8 November 2014

7 October 2015

Quick facts

Lead sponsor	Heilongjiang University of Chinese Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	1,000
Start date	6 July 2012
Primary completion	8 November 2014
Estimated completion	7 October 2015
Sites	25 locations across China

Drugs / interventions tested

• Acupuncture treatment 1
• Acupuncture treatment 2
• CC — full drug profile →
• CC placebo

Conditions studied

• Pregnancy — all drugs for Pregnancy →
• Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
• Infertility — all drugs for Infertility →

Sponsor

Heilongjiang University of Chinese Medicine

Who can join

Adults 20 to 40, female only, with Pregnancy or Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial.
   Wu XK, Stener-Victorin E, Kuang HY, Ma HL, et al · · 2017 · cited 128× · PMID 28655015 · DOI 10.1001/jama.2017.7217
2. Polycystic ovary syndrome: effect and mechanisms of acupuncture for ovulation induction.
   Johansson J, Stener-Victorin E. · · 2013 · cited 76× · PMID 24073009 · DOI 10.1155/2013/762615
3. Effect of acupuncture and metformin on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance: a three-armed randomized controlled trial.
   Wen Q, Hu M, Lai M, Li J, et al · · 2022 · cited 55× · PMID 34907435 · DOI 10.1093/humrep/deab272
4. Acupuncture and clomiphene citrate for live birth in polycystic ovary syndrome: study design of a randomized controlled trial.
   Kuang H, Li Y, Wu X, Hou L, et al · · 2013 · cited 39× · PMID 24023577 · DOI 10.1155/2013/527303
5. The Apolipoprotein B/A1 Ratio is Associated With Metabolic Syndrome Components, Insulin Resistance, Androgen Hormones, and Liver Enzymes in Women With Polycystic Ovary Syndrome.
   He H, Feng J, Zhang S, Wang Y, et al · · 2021 · cited 19× · PMID 35069437 · DOI 10.3389/fendo.2021.773781
6. 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.
   Li J, Wu Q, Wu XK, Zhou ZM, et al · · 2018 · cited 17× · PMID 29471520 · DOI 10.1093/humrep/dey027
7. Elevated baseline LH/FSH ratio is associated with poor ovulatory response but better clinical pregnancy and live birth in Chinese women with PCOS after ovulation induction.
   Xia Q, Xie L, Wu Q, Cong J, et al · · 2023 · cited 16× · PMID 36711322 · DOI 10.1016/j.heliyon.2023.e13024
8. Effect of Three Androgen Indexes (FAI, FT, and TT) on Clinical, Biochemical, and Fertility Outcomes in Women with Polycystic Ovary Syndrome.
   Zhang D, Gao J, Liu X, Qin H, et al · · 2021 · cited 12× · PMID 32989632 · DOI 10.1007/s43032-020-00316-1