Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-30 @ 10:48 AM
Study NCT ID:
NCT01573858
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2012-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome
Sponsor:
Heilongjiang University of Chinese Medicine
Organization:
Study Overview
Official Title:
Effect of Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial (PCOSAct)
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PCOSAct
Brief 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. 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).
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).
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
Primary outcomes:
\- Live birth rate
Secondary outcomes:
* Ovulation rate
* Ongoing pregnancy rate
* Multiple pregnancy rate
* Miscarriage rate
* Hormonal profile
* Metabolic profile
* Side effect profile
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: