Clinical trial · Interventional
Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)
NCT02221154CI-TRIAL-00028150FIV-INOPKterminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty recruiting
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gonadotropins; Folic Acid | Other | — | UNRESOLVED |
| Inofolic® | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Inofolic®
- description
- standard ovarian stimulation and Inofolic®
- interventionNames
- Dietary Supplement: Inofolic®
- Other: Gonadotropins; Folic Acid
- type
- ACTIVE_COMPARATOR
- label
- Gonadotropins;Folic Acid
- description
- standard ovarian stimulation without Inofolic®
- interventionNames
- Other: Gonadotropins; Folic Acid
Primary outcomes (1)
- measure
- Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 38 Years
Show eligibility criteria text
Inclusion Criteria: * Patients PCOS (Rotterdam ESHRE / ASRM criteria) Combination of at least two of the following three criteria: * Cycle disorder * Clinical hyperandrogenism and / or biological * Account antral follicles\> 24 * Age ≤ 18 ≤ 38 years * BMI \<35 kg / m² * Able to understand the protocol and signed informed consent Exclusion Criteria: * Patients not having the Rotterdam criteria * Patients\> 38 years and / or BMI\> 35 kg / m² * Woman enjoying a measure of legal protection * Hypersensitivity to any component of the Inofolic (myo-inositol, soy, folic acid, glycerol, gelatin, coloring E171) * Participation in another interventional biomedical research with treatment administered may disrupt ovarian stimulation
References
Publications (0)
Data not yet available
No reference posted for this study.