Trial · NCT01909141
Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS
NCT01909141, Early phase 1, Completed, Cairo University; results first posted 2015-03-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS. Trials, record NCT01909141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01909141
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS
- NCT number
- NCT01909141
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 100 participants, actual
- Lead sponsor
- Cairo University
- 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
- First posted
- 2013-07-26
- Last updated
- 2015-10-20
- Results first posted
- 2015-03-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ovulation Rate | 3 months | |
| Secondary | Number of Follicles>18mm. | 3 months | |
| Secondary | Endometrial Thickness | 3 months | |
| Secondary | Pregnancy Rate | 3 months | |
| Other | Safety of Pioglitazone as Regards Serum Creatinine | 3 months | serum creatinine was measured at the end of the study period (after 3 months) in both groups. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ovulation Rate | 3 months | percentage of all cycles | NUMBER | |
| SECONDARY | Number of Follicles>18mm. | 3 months | follicles | MEAN | |
| SECONDARY | Endometrial Thickness | 3 months | mm | MEAN | |
| SECONDARY | Pregnancy Rate | 3 months | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Safety of Pioglitazone as Regards Serum Creatinine | 3 months | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ovulation Rate | Arm 1:Letrozole-pioglitazone -Metformin Group | 93 | percentage of all cycles | ||
| Ovulation Rate | Arm 2: Clomiphene Citrate-pioglitazone-metformin | 108 | percentage of all cycles | ||
| Number of Follicles>18mm. | Arm 1:Letrozole-pioglitazone -Metformin Group | 1.44 | Standard Deviation 0.16 | follicles | |
| Number of Follicles>18mm. | Arm 2: Clomiphene Citrate-pioglitazone-metformin | 1.5 | Standard Deviation 0.86 | follicles | |
| Endometrial Thickness | Arm 1:Letrozole-pioglitazone -Metformin Group | 10.56 | Standard Deviation 1.79 | mm | |
| Endometrial Thickness | Arm 2: Clomiphene Citrate-pioglitazone-metformin | 9.68 | Standard Deviation 1.39 | mm | |
| Pregnancy Rate | Arm 1:Letrozole-pioglitazone -Metformin Group | 28 | participants | ||
| Pregnancy Rate | Arm 2: Clomiphene Citrate-pioglitazone-metformin | 24 | participants | ||
| Safety of Pioglitazone as Regards Serum Creatinine | Arm 1:Letrozole-pioglitazone -Metformin Group | 0.62 | Standard Deviation 0.04 | mg/dL | |
| Safety of Pioglitazone as Regards Serum Creatinine | Arm 2: Clomiphene Citrate-pioglitazone-metformin | 0.57 | Standard Deviation 0.03 | mg/dL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1:Letrozole-pioglitazone -Metformin Group | 50 | |
| Overall Study | STARTED | Arm 2: Clomiphene Citrate-pioglitazone-metformin | 50 | |
| Overall Study | COMPLETED | Arm 1:Letrozole-pioglitazone -Metformin Group | 50 | |
| Overall Study | COMPLETED | Arm 2: Clomiphene Citrate-pioglitazone-metformin | 50 | |
| Overall Study | NOT COMPLETED | Arm 1:Letrozole-pioglitazone -Metformin Group | 0 | |
| Overall Study | NOT COMPLETED | Arm 2: Clomiphene Citrate-pioglitazone-metformin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1:Letrozole-pioglitazone -Metformin Group | ||
| Total, all-cause mortality | Arm 2: Clomiphene Citrate-pioglitazone-metformin | ||
| Total, other adverse events | Arm 1:Letrozole-pioglitazone -Metformin Group | 0 | 50 |
| Total, other adverse events | Arm 2: Clomiphene Citrate-pioglitazone-metformin | 0 | 50 |
| Total, serious adverse events | Arm 1:Letrozole-pioglitazone -Metformin Group | 0 | 50 |
| Total, serious adverse events | Arm 2: Clomiphene Citrate-pioglitazone-metformin | 0 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26613820 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 1:Letrozole-pioglitazone -Metformin Group vs Arm 2: Clomiphene Citrate-pioglitazone-metformin: Pregnancy Rate | Trial comparisons |
| Arm 1:Letrozole-pioglitazone -Metformin Group vs Arm 2: Clomiphene Citrate-pioglitazone-metformin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01909141
GET https://conductscience.org/api/trials/v1/NCT01909141/registered