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clomiphene citrate is no longer being considered as standard treatment for polycystic ovary syndrome
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| Name | Class |
|---|---|
| Gedeon Richter Plc. | INDUSTRY |
| University Hospital, Antwerp | OTHER |
| AZ Jan Palfijn Gent | OTHER |
| Our Lady of Lourdes Hospital Waregem |
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Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inositol group | Experimental | Myo-inositol 4000 mg Dosing: 2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged) during 3 consecutive treatment cycles. |
|
| Clomiphene citrate group | Active Comparator | Each tablet contains 50 mg of clomiphene citrate Dosing: 1 tablet per day, per os, from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days during 3 consecutive treatment cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myo-inositol | Drug | 2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cumulative ongoing pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after 3 treatment cycles with inositol versus clomiphene citrate for ovulation induction. | Recently, a meta-analysis on the use of inositol in PCOS was published. This study showed that inositol leads to a more regular menstrual cycle and recovery of ovarian function. Less data are present on pregnancy rates. No RCT was found on the comparison between inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate. Another advantage of inositol is that it doesn't have side effects compared to metformin and that there is no elevated risk on multiple pregnancies, which is the case with clomiphene citrate. | At 7 - 8 gestational weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The number of potential adverse events | The potential adverse events will be measured to determine whether the compliance for the patient is acceptable. | During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks) |
| The occurrence of ovulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Ghent | 9000 | Belgium |
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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 |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| UNKNOWN |
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| Clomiphene Citrate | Drug | Each tablet contains 50 mg of clomiphene citrate which means 33,9 mg of clomiphene. Other constituents are sucrose, lactose monohydrate, corn starch, pregelatinized starch, yellow iron oxide (E172) and magnesium stearate (E470b). Dosing: 1 tablet per day from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days. |
|
The occurence of ovulation will be measured to determine whether the compliance for the patient is acceptable. |
| During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks) |
| The number of cancelled treatment cycles | The number of cancelled treatment cycles will be measured to determine whether the compliance for the patient is acceptable. | During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks) |
| The number of multiple pregnancies | The number of multiple pregnancies will be measured to determine whether the compliance for the patient is acceptable. | During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks) |
| 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 |
| D013267 |
| Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |