Clinical trial · Interventional
Myo-Inositol for Ovarian Stimulation and ICSI Outcomes in Women With PCOS
Impact of Inositol on Controlled Ovarian Stimulation & ICSI Outcome of Women With PCOS: Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Polycystic ovary syndrome (PCOS) is a common endocrine disorder that may affect ovarian function, insulin sensitivity, and fertility. Myo-inositol has been proposed as an insulin-sensitizing supplement that may improve metabolic and reproductive outcomes in women with PCOS. This randomized, double-blind clinical trial evaluated the effect of myo-inositol supplementation on controlled ovarian stimulation and assisted reproductive technology (ART) outcomes in women with PCOS undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). A total of 88 participants were randomly assigned to two parallel groups. The intervention group received myo-inositol combined with folic acid, while the control group received folic acid alone for 3 months before the ART cycle and until the day of oocyte retrieval. The study assessed whether myo-inositol could improve metabolic and hormonal parameters, ovarian response to stimulation, oocyte and embryo quality, and pregnancy outcomes, while also evaluating ovarian hyperstimulation syndrome (OHSS).
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 |
|---|---|---|---|
| Folic Acid | Dietary Supplement | — | UNRESOLVED |
| Myo-Inositol | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Myo-Inositol Plus Folic Acid
- description
- Participants received myo-inositol 600 mg combined with folic acid 0.24 mg twice daily for 3 months before starting the assisted reproductive technology (ART) cycle and continued treatment until the day of oocyte retrieval.
- interventionNames
- Dietary Supplement: Myo-Inositol
- type
- ACTIVE_COMPARATOR
- label
- Folic Acid Control
- description
- Participants received folic acid 0.24 mg for 3 months before starting the assisted reproductive technology (ART) cycle and continued treatment until the day of oocyte retrieval.
- interventionNames
- Dietary Supplement: Folic Acid
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Female participants aged 18 to 40 years. * Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria. * Normal thyroid hormone levels. * Normal prolactin levels. * Candidates for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). Exclusion Criteria: * Previous ovarian surgery. * History of endometrioma. * History of endocrine disease, including congenital adrenal hyperplasia or diabetes mellitus. * Smoking. * Known allergy to myo-inositol. * Current use of oral contraceptive pills. * Receipt of hormonal medications within the 3 months before study enrollment. * Refusal to participate in the study.
References
Publications (0)
Data not yet available