CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 100 enrolled
Drug / intervention
induction of ovulation using letrozole-pioglitazone-metformin +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01909141
NCT01909141Early Ph 1Completed
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Combined Letrozole-metformin-pioglitazone Versus Combined Clomiphene Citrate-metformin-pioglitazone in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome

Cairo University·interventional·Posted Jul 26, 2013·Updated Oct 20, 2015

In Brief

A Early Phase 1 clinical trial evaluating induction of ovulation using letrozole-pioglitazone-metformin, induction of ovulation using clomiphene citrate-pioglitazone-metformin, and 7 other interventions for Polycystic Ovary Syndrome and Infertility. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome, Infertility
CountriesEgypt
Collaborators--

Timeline

Early Ph 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 26, 2013
Enrollment StartAug 1, 2013
Primary CompletionFeb 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.9 years ago

Interventions

induction of ovulation using letrozole-pioglitazone-metformindrug

induction of ovulation will be done for arm 1 for 3 consecutive cycles unless pregnancy occured.

induction of ovulation using clomiphene citrate-pioglitazone-metformindrug

induction of ovulation for arm 2 will be done in 3 consecutive cycles unless pregnancy occured.

transvaginal ultrasoundradiation

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) calculationother

BMI will be calculated for all women by dividing the weight in kilograms by the height in meters squared

day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosteroneother

baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) will be done for all women.

pretreatment blood urea and serum creatinineother

blood urea and serum creatinine will be assayed before stating induction of ovulation to have baseline levels.

serum estradiol (E2) on day 12other

serum E2 will be assayed on day 12 of the cycle for all women.

serum progesterone on day 21other

serum progesterone will be assayed on day 21 for all women to monitor ovulation.

blood urea and serum creatinine every monthother

blood urea and serum creatinine will be assayed every month during the treatment period to find out any hazards on kidney functions