PCOS is the biggest cause of infertility due to ovulation disorders and the management and treatment of ovulation and menstrual disorders includes approximately 30% of the high cost of treatment. Clomiphene is often prescribed for treatment. Resistance to clomiphene and its failure to treatment are both common. Clinical and laboratory findings of previous studies suggest that acupuncture may induce ovulation and increase fertility in women with PCOS. This study aims to compare the effect of acupuncture with clomiphene to induce ovulation in PCOS. All patients with polycystic ovary syndrome referred to gynecology clinic of Imam Reza (AS) based on Rotterdam diagnostic criteria will be entered the study by simple-non probability sampling if they conform with inclusion and exclusion criteria, and will be put in one of two groups, intervention (real acupuncture + placebo clomiphene) and control (sham acupuncture + clomiphene). Treatment will start at day 3 after the start of spontaneous period or a Bleeding after progesterone consumption in both groups. Both groups will be treated with acupuncture/sham acupuncture for a maximum of 32 treatment sessions over 16 weeks (twice a week). Clomiphene citrate 50 mg daily will be prescribed to patients in control group for 5 days in 5 cycles. Same regimen will be prescribed for placebo in the intervention group. Serial ovarian trans-vaginal ultrasonography will be done from the third cycle day every 3 days until ovulation occurs. Detection of side effects during the study period will be recorded and compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512057265N3
Registration date:2015-12-23, 1394/10/02
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-12-23, 1394/10/02
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-12-13, 1394/09/22
Expected recruitment end date
2016-05-11, 1395/02/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison acupuncture with Clomiphene for ovulation induction in polycystic ovary syndrome
Public title
Comparison acupuncture with Clomiphene for ovulation induction in polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 to 40 years old; chronic oligomenorrhea or amenorrhea (oligomenorrhea is defined as intervals more than 35 days between Menstruations or Menstrual frequency less than 8 times in the last year. Amenorrhea is defined as intervals more than 90 days between the two periods); hyperandrogenism (Hirsutism or Hyperandrogenism) or polycystic ovaries on ultrasound. Hyperandrogenism criterion: serum testosterone level higher than 80 mg/dl. Hirsutism criterion: modified ferriman–Gallwey score more than or equal to 5. Ultrasound criterion: more than 12 antral follicles (2 to 9 mm) or ovarian volume greater than 10 cc in vaginal ultrasound.
Exclusion criteria: simultaneous other endocrine disorders: hyperprolactinemia, FSH higher than 15 (having a normal FSH during the past year is enough); TSH less than 0.2 or higher than 5.5 (having a normal TSH during the past year is enough); diabetes, suspected Cushing's syndrome; using hormonal drugs or herbal medicine containing hormones during the last three months; pregnancy within 6 weeks; abortion or childbirth in the last 6 months; breast-feeding in the last 6 months; not wanting to inclusion; liver and kidney disorders; hemoglobin less than 10; history of DVT, pulmonary embolism or CVA; dependence on alcohol or narcotic drugs; taking other medicines that affect reproductive or metabolic functions like OCP, GnRH agonists and antagonists; uncontrolled hypertension; illiteracy or lack of willingness to cooperate in the study.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
MUM's central office, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
940058
Health conditions studied
1
Description of health condition studied
Polycystic Ovary Syndrome
ICD-10 code
F28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Ovulation
Timepoint
Every three days since subjects entered the study
Method of measurement
Serial vaginal ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
Control group: sham acupuncture + clomiphene
Category
Treatment - Other
2
Description
Intervention group: Real acupuncture + placebo Clomiphene
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr Leili Hafizi Lotfabadi
Street address
Gynecology clinic, Imam Reza Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
MUM's central office, Daneshgah street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Gynecology, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hamideh Azizi
Position
Gynecology resident
Other areas of specialty/work
Street address
Department of Gynecology, Imam Reza hospital
City
Mashhad
Postal code
Phone
+98 915 519 8656
Fax
Email
azizih921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Chinese and complementary Medicine
Full name of responsible person
Dr. Hoda Azizi
Position
MD, PhD in Acupuncture, Assistant Professor
Other areas of specialty/work
Street address
Department of Chinese and complementary Medicine
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
azizih@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoda Azizi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Chinese and Complementary Medicine
City
Mashhad
Postal code
Phone
Fax
Email
azizih@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)