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Difficulty recruiting
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The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients.
The aim of the study is to demonstrate that administration of myo-inositol decreases the incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS supported in IVF patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inofolic® | Experimental | standard ovarian stimulation and Inofolic® |
|
| Gonadotropins;Folic Acid | Active Comparator | standard ovarian stimulation without Inofolic® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inofolic® | Dietary Supplement |
| ||
| Gonadotropins; Folic Acid |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations | 3 month |
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Inclusion Criteria:
Combination of at least two of the following three criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabienne DELAY, PH | CHD Vendée La Roche sur Yon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI de Créteil | Créteil | 94000 | France | |||
| CHD Vendée |
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standard ovarian stimulation |
|
| La Roche-sur-Yon |
| 85925 |
| France |
| CHU de Nantes | Nantes | 44093 | France |
| CH de Saint Nazaire | Saint-Nazaire | 44606 | France |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| 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 |
|---|---|
| D006062 | Gonadotropins |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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