Clinical trial · Interventional
Myo-inositol Versus Clomiphene Citrate in PCOS
Myo-inositol Versus Clomiphene Citrate as First Line Treatment for Ovulation Induction in PCOS
NCT04306692CI-TRIAL-00062813terminatedPhase 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): clomiphene citrate is no longer being considered as standard treatment for polycystic ovary syndrome
Summary
Brief summary (as posted)
Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clomiphene | — | UNRESOLVED | — |
| Inositol | — | UNRESOLVED | — |
| Ovulation Induction | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clomiphene Citrate | Drug | — | UNRESOLVED |
| Myo-inositol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Inositol group
- description
- 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.
- interventionNames
- Drug: Myo-inositol
- type
- ACTIVE_COMPARATOR
- label
- Clomiphene citrate group
- description
- 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.
- interventionNames
- Drug: Clomiphene Citrate
Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Rotterdam criteria for PCOS (cf. the recent ESHRE guidelines): at least 2 out of 3 criteria should be fulfilled: irregular cycle (shorter than 21 days or longer than 35 days); clinical (modified Ferriman-Gallwey score ≥ 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx); PCO ovaries on ultrasound (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx): multiple small cysts (≥ 20 per ovary and/or an ovarian volume ≥ 10 ml, measured with a probe \>8 MHz) in both ovaries. * A first treatment cycle, possibly combined with intra uterine insemination (IUI) and this for (one of) the following reasons: mild male factor (as defined by each local center) endometriosis AFS score 1 or 2 * Use of own or donor sperm. Exclusion Criteria: * Tubal factors * Uterine factors * Endometriosis AFS score 3 or 4 * Moderate to severe male factor (as defined by each local center) * BMI \> 35
References
Publications (0)
Data not yet available
No reference posted for this study.