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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No: 2006-006514-15 |
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| Name | Class |
|---|---|
| University Hospitals of Derby and Burton NHS Foundation Trust | OTHER |
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The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clomiphene citrate | Active Comparator | Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg |
|
| Letrozole | Active Comparator | Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | 14 moths |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Ovulation rate 2. Number of growing and mature follicles during treatment 3. Miscarriage rate 4. Live-birth rate 5. Multiple pregnancy rate 6. Endometrial thickness | 14 months |
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Inclusion Criteria:
Age: 18 - 39
BMI < 36
Infertility due to anovulation
PCOS: At least two of the following diagnostic criteria of:
No recent (within 6 months) treatment for induction of ovulation
Normal semen analysis (WHO 1999)
Proven patency of at least one Fallopian tube
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saad Amer, MD, MRCOG | University of Nottingham and Derby Hospitals NHS foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Derby Hospital | Derby | Derbyshire | DE22 3NE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28854590 | Derived | Amer SA, Smith J, Mahran A, Fox P, Fakis A. Double-blind randomized controlled trial of letrozole versus clomiphene citrate in subfertile women with polycystic ovarian syndrome. Hum Reprod. 2017 Aug 1;32(8):1631-1638. doi: 10.1093/humrep/dex227. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D011085 | Polycystic Ovary Syndrome |
| D000858 | Anovulation |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
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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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| Clomifene citrate | Drug | Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg |
|
| D009369 |
| Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| 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 |