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A randomized controlled trial to evaluate whether pretreatment with myo-inositol can lower testosterone levels and improve clinical outcomes in hyperandrogenic PCOS patients undergoing ART
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myo-inositol | Experimental | Pretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology) |
|
| Folic acid | Other | Folic acid 0.4 mg daily during 12 weeks before start of ART |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myo-inositol | Drug | Myo-inositol and Folic acid daily |
| |
| Folic Acid |
| Measure | Description | Time Frame |
|---|---|---|
| Serum testosterone level after 12 weeks of administration of Myo-Inositol | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol | 2 years | |
| Number of mature oocytes | 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel De Vos, PhD | Contact | +3224776699 | michel.devos@uzbrussel.be | |
| Sylvie De Rijdt, MD | Contact | sylvie.derijdt@uzbrussel.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Brussels | 1090 | Belgium |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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Randomized controlled trial
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| Drug |
Folic Acid daily |
|
| Embryo quality |
Day 3 embryos will be classified as transferable or cryopreservable/ 'good-quality embryos' (GQE) according to the criteria described by Van Landuyt et al. (2013). Blastocysts will be categorized according to Gardner et al. (1998) and Gardner and Schoolcraft (1999). |
| 2 years |
| Implantation rate (%) | 2 years |
| Clinical pregnancy rate (%) | 2 years |
| Live birth rate in fresh cycle | 2 years |
| Cumulative live birth rate after 1 cycle | 2 years |
| Ovarian Hyperstimulation Syndrome rate | 2 years |
| Consumption of gonadotrophins | measurement in IU | 2 years |
| Stimulation days | measurement in days | 2 years |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D011622 |
| Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |