Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS

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.

Conditions

• Polycystic Ovary Syndrome
• Infertility

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

Sponsors & Collaborators

• Cairo University

  lead OTHER

Principal Investigators

• Ghada Abdel Fattah Abdel Moety, lecturer · Cairo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2014-02-28

Completion

2014-04-30

Countries

• Egypt

Study Locations