Comparison · NCT01909141-sae
Arm 1:Letrozole-pioglitazone -Metformin Group vs Arm 2: Clomiphene Citrate-pioglitazone-metformin: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm 1:Letrozole-pioglitazone -Metformin Group vs Arm 2: Clomiphene Citrate-pioglitazone-metformin: serious adverse events. Trial comparisons, record NCT01909141-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01909141-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0.00000000000000000694 | 0.0713 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000694 | 0.0713 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0713 | 0.0713 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm 1:Letrozole-pioglitazone -Metformin Group | Arm 1 received 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.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of \> 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women. | 0 | 50 | EG000 |
| Group 2 | Arm 2: Clomiphene Citrate-pioglitazone-metformin | Arm 2 received 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.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of \> 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women. | 0 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS
- NCT number
- NCT01909141
- Phases
- EARLY_PHASE1
- Conditions
- Polycystic Ovary Syndrome, Infertility
- Interventions
induction of ovulation using letrozole-pioglitazone-metformin, induction of ovulation using clomiphene citrate-pioglitazone-metformin, transvaginal ultrasound, body mass index (BMI) calculation, day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone, pretreatment blood urea and serum creatinine, serum estradiol (E2) on day 12, serum progesterone on day 21, blood urea and serum creatinine every month
- Lead sponsor
- Cairo University
- Results first posted
- 2015-03-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01909141?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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