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The goal of this clinical trial is to learn if drug letrozole in step up dose works better to treat anovulation in infertile women with polycystic ovary syndrome. It will also learn about the safety of drug letrozole in step up dose. The main Questions it aims to answer are:
Participants will:
Background: Polycystic ovary syndrome (PCOS) is the largest single cause of anovulatory infertility. Letrozole, an aromatase inhibitor, has been regarded as the first-line drug for ovulation induction in PCOS patients. The conventional protocol of letrozole includes the administration of a fixed dose of letrozole (2.5 -7.5 mg) for 5 days. Few recent studies have shown that the step-up letrozole protocol causes more follicles to grow, induces more ovulation, and increases the pregnancy rate. This study aimed to compare the effect of the letrozole step-up and conventional fixed-dose protocol for ovulation induction in infertile women with PCOS.
Methods: This open-label randomized controlled study was conducted on a total of 70 infertile PCOS women eligible for ovulation induction. Treatment with letrozole started from day 2-3 of menstruation or withdrawal bleeding. They were randomly allocated into two groups. The experimental group (n=35) was given step-up letrozole, one (2.5 mg), two (5 mg), three (7.5 mg), and four (10 mg) tablets, single dose sequentially for 4 days. The comparator group (n=35) received conventional fixed-dose letrozole, two (5mg) tablets daily for 5 days. The outcome variables were the number of participants having a mature follicle by day 12-16 of the cycle and the number of mature follicles on the day of trigger.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole step up | Experimental | Tab letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days |
|
| Conventional fixed dose letrozole | Active Comparator | Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozol step up dose | Drug | Tablet letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants having mature follicle (mean diameter ≥18mm) | The number of participants having mature follicle (mean diameter ≥18mm) on day 12 to 16 of the cycle | 3 months |
| The number of participants having adequate endometrial thickness ( 7mm or more) | The number of participants having adequate endometrial thickness ( 7mm or more) on the day of trigger | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangabandhu Sheikh Mujib Medical University | Dhaka | 1200 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31631248 | Background | Kaur J, Suri V, Gainder S, Arora A. Prospective randomized trial comparing efficacy of letrozole step-up protocol with letrozole plus gonadotropins for controlled ovarian stimulation and intrauterine insemination in patients with unexplained infertility. Arch Gynecol Obstet. 2019 Dec;300(6):1767-1771. doi: 10.1007/s00404-019-05326-2. Epub 2019 Oct 20. |
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| Conventional fixed dose letrozole | Drug | Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle |
|
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | 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 |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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