Clinical trial · Interventional
Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS
Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
NCT02344888CI-TRIAL-00036389unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clomiphene citrate and folic acid | Drug | — | UNRESOLVED |
| Clomiphene citrate and Prednisolone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Clomiphene citrate-Prednisolone group
- description
- Women will receive clomiphene citrate and prednisolone
- interventionNames
- Drug: Clomiphene citrate and Prednisolone
- type
- ACTIVE_COMPARATOR
- label
- Clomiphene citrate-placebo group
- description
- Women will receive clomiphene citrate and folic acid 0.5mg (placebo)
- interventionNames
- Drug: Clomiphene citrate and folic acid
Primary outcomes (1)
- measure
- Ovulation rate
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Infertile lean women with PCOS as defined by the Rotterdam criteria. * CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles). Exclusion Criteria: * Age \< 20 or \> 35 years. * Body mass index (BMI) \< 18.5 kg/m2 or \> 25 kg/m2. * Presence of any infertility factor other than anovulatory PCOS. * Previous history of ovarian surgery or surgical removal of one ovary. * Previous exposure to cytotoxic drugs or pelvic irradiation. * Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months. * Metabolic or hormonal abnormalities
References
Publications (0)
Data not yet available
No reference posted for this study.