Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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 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 has a long half-life (2 weeks), and this may have a negative effect on the cervical mucus and endometrium, leading to discrepancy between ovulation and conception rates. There has been a search for a compound capable of inducing ovulation but devoid of the adverse antiestrogenic effects of CC. recent studies have suggested that letrozole, an aromatase inhibitor, does not possess the adverse antiestrogenic effects of CC and is associated with higher pregnancy rates than CC treatment in patients with PCOS.

In this study we shall compare the effect of combined letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.This will be a prospective comparative clinical trial in which 2 groups of women will be generated (groups A and B) using the sealed envelopes randomization method.Group A (40 women) will receive: letrozole 2.5 mg/day from 3rd day of the cycle for 5 days and (pioglitazone 15 mg + metformin 850 mg) once daily from 1st day of the cycle for 10 days. Group B (40 women) will receive clomiphene citrate 100 mg/day from 3rd day of the cycle for 5 days and (pioglitazone 15 mg + metformin 850 mg) once daily from 1st day of the cycle for 10 days. Ovulation will be monitored by vaginal ultrasound and serum estrogen and progesterone.

Conditions

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Polycystic Ovary Syndrome Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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arm 1:letrozole-pioglitazone -metformin group

Arm 1 will receive 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.

Group Type ACTIVE_COMPARATOR

induction of ovulation using letrozole-pioglitazone-metformin

Intervention Type DRUG

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

transvaginal ultrasound

Intervention Type RADIATION

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

Intervention Type OTHER

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 testosterone

Intervention Type OTHER

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

pretreatment blood urea and serum creatinine

Intervention Type OTHER

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

serum estradiol (E2) on day 12

Intervention Type OTHER

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

serum progesterone on day 21

Intervention Type OTHER

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

blood urea and serum creatinine every month

Intervention Type OTHER

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

arm 2: clomiphene citrate-pioglitazone-metformin

Arm 2 will receive 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.

Group Type ACTIVE_COMPARATOR

induction of ovulation using clomiphene citrate-pioglitazone-metformin

Intervention Type DRUG

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

transvaginal ultrasound

Intervention Type RADIATION

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

Intervention Type OTHER

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 testosterone

Intervention Type OTHER

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

pretreatment blood urea and serum creatinine

Intervention Type OTHER

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

serum estradiol (E2) on day 12

Intervention Type OTHER

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

serum progesterone on day 21

Intervention Type OTHER

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

blood urea and serum creatinine every month

Intervention Type OTHER

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

Interventions

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induction of ovulation using letrozole-pioglitazone-metformin

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

Intervention Type 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.

Intervention Type DRUG

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

Intervention Type RADIATION

body mass index (BMI) calculation

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

Intervention Type 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.

Intervention Type OTHER

pretreatment blood urea and serum creatinine

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

Intervention Type OTHER

serum estradiol (E2) on day 12

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

Intervention Type OTHER

serum progesterone on day 21

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 20-40 years old
* PCOS infertile women resistant to CC for3 cycles

Exclusion Criteria

* presence of medical disorders as diabetes, hypertension, cardiac problems, liver or kidney diseases, hyperprolactinemia or thyroid dysfunction.
* use of gonadotropins before
* previous ovarian drilling
* presence of urinary symptoms especially bloody urine

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No