Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-12-31

Brief Summary

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It was randomised controlled study to compare the efficacy of clomiphene and letrozole in polycystic ovarian syndrome(PCOS) women with infertility.The aim was to select more appropriate treatment for ovulation induction in PCOS women.

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Detailed Description

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The prevalence of infertility due to polycystic ovarian syndrome in Pakistan is 21.9%.It leads to an ovulation which results in infertility.The objective of this study was to compare the efficacy of letrozole vs clomiphene citrate for ovulation induction in PCOS women.Methods.It was a randomised controlled trial conducted in department of gynaecology and obstetrics ,Services Hospital Lahore from 2016-2019.

Total 230 patients were included in study, they were divided in two groups, out of which 220 patients were analysed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days. Transvaginal ultrasound monitoring done from day 10-12 of menstrual cycle to measure follicle number and size.When follicle achieved a diameter of 18-20mm, then Inj HCG(human chorionic gonadotropin)10,000 IU intramuscular was given. Ovulation was confirmed by day 21 S.progesterone. When patient conceived, they were followed up till delivery.

Conditions

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Polycystic Ovary Syndrome Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Total 230 patients were randomized in study, divided in two groups by computer generated numbers, out of which 220 patients were analyzed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Two treatment groups were made by random computer generated number i.e. Group A and Group B. Two Concealed boxes labelling A and B containing study drugs were made by pharmacist.Then participants were given drug from concealed boxes according to computer generated number.

Study Groups

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letrozole

Patients were given letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.

Group Type EXPERIMENTAL

letrozole 2.5mg-7.5mg

Intervention Type DRUG

Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.

Clomiphene citrate

Patients were given clomiphene citrate 50-150mg per day for 5 days started from 2nd day of the menses.

Group Type ACTIVE_COMPARATOR

Clomiphene Citrate 50mg-150mg

Intervention Type DRUG

Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.

Interventions

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letrozole 2.5mg-7.5mg

Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.

Intervention Type DRUG

Clomiphene Citrate 50mg-150mg

Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.

Intervention Type DRUG

Other Intervention Names

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tab lezra 2.5-7.5mg tab clomid 50-150mg

Eligibility Criteria

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Inclusion Criteria

* Women age between 18-40 years.
* Normal husband semen analysis.

Exclusion Criteria

* All infertile couples who had other causes of infertility than PCOS.
* Those who had recently taken these medications.
* Any contraindication to use of drugs e.g renal or hepatic dysfunction, hypersensitivity to this drug.
* BMI\>35 because obese women respond poorly to ovulation induction.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes