Protocol summary
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Study aim
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To compare the effectiveness of acupuncture with clomiphene in stimulating ovulation in infertile women with polycystic ovary syndrome
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Design
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Clinical trial with control group, parallel, single-blind, randomized, on 110 patients with simple randomization.
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Settings and conduct
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Clinical trial on infertile PCOS patients referred to women's clinic of Imam Reza Hospital and Milad Infertility Center, Mashhad, Iran
Acupuncture (real or sham) for up to 3 cycles, twice a week
Clomiphene (real or placebo) at a daily rate of 50, 100 and 150 mg in the first to third cycle of treatment from the third day of the cycle for 5 days
Evaluation based on serial vaginal ultrasound in each cycle in terms of follicle growth and proof of ovulation
In this study, patients were blinded to the type of treatment. Also, gynecologist, statistical analyst and research assistant (interrogator) were blinded to the study groups. Only the acupuncturist was aware of patients' groups.
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Participants/Inclusion and exclusion criteria
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Inclusion conditions: age between 20 and 40 years; suffering from infertility and polycystic ovary syndrome according to the Rotterdam criteria.
Conditions of non-inclusion: simultaneous presence of other endocrine, hepatic and renal disorders; taking hormonal or herbal medicines containing hormones during the last three months; pregnancy, miscarriage or childbirth in the last 6 months; history of thromboembolism; drug dependence; Uncontrolled blood pressure
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Intervention groups
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intervention group (real acupuncture + clomiphene placebo)
control group (real clomiphene + sham acupuncture)
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Main outcome variables
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Primary endpoint: ovulation rate in two groups
Secondary outcomes: the number of developing follicles (greater than or equal to 14 mm) and mature follicles (greater than or equal to 18 mm); Adverse events
General information
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Reason for update
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We decided to include the actual day patients entered the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201512057265N3
Registration date:
2015-12-23, 1394/10/02
Registration timing:
prospective
Last update:
2023-06-28, 1402/04/07
Update count:
1
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Registration date
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2015-12-23, 1394/10/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Deputy of Research of Mashhad University of Medical Sciences
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Expected recruitment start date
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2015-12-13, 1394/09/22
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Expected recruitment end date
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2016-05-11, 1395/02/22
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Actual recruitment start date
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2015-12-25, 1394/10/04
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Actual recruitment end date
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2016-07-24, 1395/05/03
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Trial completion date
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2016-10-30, 1395/08/09
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Scientific title
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Comparison acupuncture with Clomiphene for ovulation induction in polycystic ovary syndrome
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Public title
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Comparison acupuncture with Clomiphene for ovulation induction in polycystic ovary syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with infertility and polycystic ovary syndrome
Exclusion criteria:
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Age
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From 20 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
110
Actual sample size reached:
77
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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simple randomization
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, patients were blinded to the type of treatment. Also, the gynecologist, statistical analyst and research assistant (interrogator) were blinded to the study groups. Only the acupuncturist was informed of the patients' groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-12-01, 1394/09/10
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Ethics committee reference number
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IR.MUMS.fm.REC.1394.346
Health conditions studied
1
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Description of health condition studied
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Polycystic Ovary Syndrome
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ICD-10 code
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F28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Ovulation
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Timepoint
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Every three days since subjects entered the study
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Method of measurement
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Serial vaginal ultrasonography
Intervention groups
1
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Description
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Control group: sham acupuncture + clomiphene
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Category
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Treatment - Other
2
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Description
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Intervention group: Real acupuncture + placebo Clomiphene
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available