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In polycystic ovary syndrome (PCOS), changes in physical appearance i.e. weight gain, hirsutism, menstrual disturbances and infertility result in reduced quality-of-life. PCOS is one of the most common endocrine disorders affecting about 4% to 8% of women of reproductive age. Diagnosis is primarily clinical with Rotterdam criteria being the most commonly followed criteria, which require the presence of two out of the three criteria including oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound.
The objective of this study is to compare the outcome of Metformin versus Myo-inositol in the management of polycystic ovarian disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months | Experimental | Informed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral myoinositol 1g twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma |
|
| In group B, females will be prescribed oral metformin 850 mg twice daily for 3 months | Active Comparator | Informed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myoinositol | Drug | In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| LH/FSH ratio | It will be assessed in terms of ratio between LH and FSH after 3 months of treatment. | 3 Months |
| Regular cycles | It will be labeled if number of days from the start (day 1) of one period until the start (day 1) of the next period are almost equal for at least 3 months | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Fatima Tariq, MBBS | Contact | +92315491846 | ftmtariq@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMH Gujranwala | Guiranwala | Punjab Province | 52230 | Pakistan |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Metformin | Drug | In group B, females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months. |
|
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001645 |
| Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |