Aim of study: Comparison of effectiveness of inositol and metformin in infertile women with polycystic ovary syndrome (PCOS) treated with letrozole and gonadotropin Study design: one blind randomized. Study population: this study is a randomized single blind controlled clinical trial undertaken in 80 infertile PCOS women from 2015-2016. Inclusion criteria: Patients with polycystic ovary syndrome according to Rotterdam criteria; age 15-38 years old. Exclusion criteria: no desire to cooperation. Study sample: 80 people. Intervention: For all patients, letrozole is prescribed at a dose of 2.5 mg per day from the third day of menstruation for 5 days. The patients were then evaluated during 12 to 16 menstrual cycles to evaluate the response to the drug, the size of the follicles reached in the ovary and the thickness of the endometrium by vaginal ultrasonography. When at least one mature follicle is seen, injections of 10,000 units of gonadotrophin are injected. Patients who did not ovulate after letrozole for a continuous dose of 7.5 mg after three continuous cycles were included in the study and were divided into three groups: in group 1, inositol 2 g plus 200 micrograms of folic acid twice daily; group II , 1500 mg of metformin daily plus 200 micrograms of folic acid and group 3, 200 micrograms of folic acid (as a placebo) for three months Primary outcomes: ovary function, pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070234845N1
Registration date:2017-10-02, 1396/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-02, 1396/07/10
Registrant information
Name
Sajadeh Pourghasem
Name of organization / entity
Hormozgan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
Email address
pourghasem@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of inositol and metformin in infertile women with polycystic ovary syndrome (PCOS) treated with letrozole and gonadotropin
Public title
Comparison of effectiveness of inositol and metformin in infertile women with polycystic ovary syndrome (PCOS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome according to Rotterdam criteria; age 15-38 years old. Exclusion criteria: no desire to cooperation
group 1, inositol 2 g plus 200 micrograms of folic acid twice daily; group II , 1500 mg of metformin daily plus 200 micrograms of folic acid and group 3, 200 micrograms of folic acid (as a placebo) for three months