Clinical trial · Interventional
Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS
Combined Letrozole-metformin-pioglitazone Versus Combined Clomiphene Citrate-metformin-pioglitazone in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome
- 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) 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.
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 Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood urea and serum creatinine every month | Other | — | UNRESOLVED |
| body mass index (BMI) calculation | Other | — | UNRESOLVED |
| day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone | Other | — | UNRESOLVED |
| induction of ovulation using clomiphene citrate-pioglitazone-metformin | Drug | — | UNRESOLVED |
| induction of ovulation using letrozole-pioglitazone-metformin | Drug | — | UNRESOLVED |
| pretreatment blood urea and serum creatinine | Other | — | UNRESOLVED |
| serum estradiol (E2) on day 12 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- arm 1:letrozole-pioglitazone -metformin group
- description
- Arm 1 will receive letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.
- interventionNames
- Drug: induction of ovulation using letrozole-pioglitazone-metformin
- Radiation: transvaginal ultrasound
- Other: body mass index (BMI) calculation
- Other: day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone
- Other: pretreatment blood urea and serum creatinine
- Other: serum estradiol (E2) on day 12
- Other: serum progesterone on day 21
- Other: blood urea and serum creatinine every month
- type
- ACTIVE_COMPARATOR
- label
- arm 2: clomiphene citrate-pioglitazone-metformin
- description
- Arm 2 will receive clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDEl-khayat W, Abdel Moety G, Al Mohammady M, Hamed D. A randomized controlled trial of clomifene citrate, metformin, and pioglitazone versus letrozole, metformin, and pioglitazone for clomifene-citrate-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2016 Feb;132(2):206-9. doi: 10.1016/j.ijgo.2015.06.063. Epub 2015 Nov 6. PMID 26613820