Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

April 30, 2014

Conditions
Polycystic Ovary SyndromeInfertility
Interventions
DRUG

induction of ovulation using letrozole-pioglitazone-metformin

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

DRUG

induction of ovulation using clomiphene citrate-pioglitazone-metformin

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

RADIATION

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

OTHER

body mass index (BMI) calculation

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

OTHER

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) will be done for all women.

OTHER

pretreatment blood urea and serum creatinine

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

OTHER

serum estradiol (E2) on day 12

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

OTHER

serum progesterone on day 21

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

OTHER

blood urea and serum creatinine every month

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

Trial Locations (1)

Unknown

Cairo University, Cairo

All Listed Sponsors
lead

Cairo University

OTHER

NCT01909141 - Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS | Biotech Hunter | Biotech Hunter