Early Phase 1
Completed N=100
Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS
Source: ClinicalTrials.gov NCT01909141 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Ovulation Rate — 93; 108 percentage of all cycles
Summary
Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ovulation Rate |
93; 108 | — |
| SECONDARY Number of Follicles>18mm. |
1.44; 1.5 | — |
| SECONDARY Endometrial Thickness |
10.56; 9.68 | — |
| SECONDARY Pregnancy Rate |
28; 24 | — |
Eligibility Criteria
Inclusion Criteria
- 20-40 years old
- PCOS infertile women resistant to CC for3 cycles
Exclusion Criteria
- presence of medical disorders as diabetes, hypertension, cardiac problems, liver or kidney diseases, hyperprolactinemia or thyroid dysfunction.
- use of gonadotropins before
- previous ovarian drilling
- presence of urinary symptoms especially bloody urine
Data sourced from ClinicalTrials.gov (NCT01909141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.