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It was randomised controlled study to compare the efficacy of clomiphene and letrozole in polycystic ovarian syndrome(PCOS) women with infertility.The aim was to select more appropriate treatment for ovulation induction in PCOS women.
The prevalence of infertility due to polycystic ovarian syndrome in Pakistan is 21.9%.It leads to an ovulation which results in infertility.The objective of this study was to compare the efficacy of letrozole vs clomiphene citrate for ovulation induction in PCOS women.Methods.It was a randomised controlled trial conducted in department of gynaecology and obstetrics ,Services Hospital Lahore from 2016-2019.
Total 230 patients were included in study, they were divided in two groups, out of which 220 patients were analysed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days. Transvaginal ultrasound monitoring done from day 10-12 of menstrual cycle to measure follicle number and size.When follicle achieved a diameter of 18-20mm, then Inj HCG(human chorionic gonadotropin)10,000 IU intramuscular was given. Ovulation was confirmed by day 21 S.progesterone. When patient conceived, they were followed up till delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| letrozole | Experimental | Patients were given letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses. |
|
| Clomiphene citrate | Active Comparator | Patients were given clomiphene citrate 50-150mg per day for 5 days started from 2nd day of the menses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| letrozole 2.5mg-7.5mg | Drug | Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | Total number of patients conceived after treatment | 5th week of cycle when periods missed |
| Measure | Description | Time Frame |
|---|---|---|
| ovulation rate | when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone. | 10-22 day of cycle |
| Live birth rate | total number of live births divided by total number of patients in a group |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Services Institute of Medical sciences | Lahore | Punjab Province | 54000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38196458 | Derived | Wasim T, Nasrin T, Zunair J, Irshad S. Efficacy of Letrozole vs Clomiphene Citrate for induction of ovulation in women with polycystic ovarian syndrome. Pak J Med Sci. 2024 Jan-Feb;40(1Part-I):78-83. doi: 10.12669/pjms.40.1.7971. |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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Total 230 patients were randomized in study, divided in two groups by computer generated numbers, out of which 220 patients were analyzed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days.
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Two treatment groups were made by random computer generated number i.e. Group A and Group B. Two Concealed boxes labelling A and B containing study drugs were made by pharmacist.Then participants were given drug from concealed boxes according to computer generated number.
| Clomiphene Citrate 50mg-150mg | Drug | Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses. |
|
|
| 9 months |
| Monofollicular development | when only one follicle achieve diameter of greater than or equal to 18mm | 10-12 day of menstrual cycle |
| Multifollicular development | when 2 or more follicles achieve diameter of >12mm | 10-12 day of menstrual cycle |
| Miscarraige | spontaneous loss of pregnancy before 24 weeks of gestation | Less than 24weeks |
| Adverse effects | hot flushes. | first 10days of cycle |
| Adverse effects | Fatigue and dizziness | first 10days of cycle |
| 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 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |