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

Primary Purpose

Polycystic Ovary Syndrome, Infertility

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
letrozole 2.5mg-7.5mg
Clomiphene Citrate 50mg-150mg
Sponsored by
Services Institute of Medical Sciences, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring polycystic ovary syndrome, Infertility, Clomiphene citrate, Letrozole

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Services Institute of Medical sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

letrozole

Clomiphene citrate

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pregnancy rate
Total number of patients conceived after treatment

Secondary Outcome Measures

ovulation rate
when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone.
Live birth rate
total number of live births divided by total number of patients in a group
Monofollicular development
when only one follicle achieve diameter of greater than or equal to 18mm
Multifollicular development
when 2 or more follicles achieve diameter of >12mm
Miscarraige
spontaneous loss of pregnancy before 24 weeks of gestation
Adverse effects
hot flushes.
Adverse effects
Fatigue and dizziness

Full Information

First Posted
December 8, 2022
Last Updated
January 18, 2023
Sponsor
Services Institute of Medical Sciences, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05702957
Brief Title
Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome
Official Title
Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome: Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Institute of Medical Sciences, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Infertility
Keywords
polycystic ovary syndrome, Infertility, Clomiphene citrate, Letrozole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
letrozole
Arm Type
Experimental
Arm Description
Patients were given letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.
Arm Title
Clomiphene citrate
Arm Type
Active Comparator
Arm Description
Patients were given clomiphene citrate 50-150mg per day for 5 days started from 2nd day of the menses.
Intervention Type
Drug
Intervention Name(s)
letrozole 2.5mg-7.5mg
Other Intervention Name(s)
tab lezra 2.5-7.5mg
Intervention Description
Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate 50mg-150mg
Other Intervention Name(s)
tab clomid 50-150mg
Intervention Description
Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.
Primary Outcome Measure Information:
Title
Pregnancy rate
Description
Total number of patients conceived after treatment
Time Frame
5th week of cycle when periods missed
Secondary Outcome Measure Information:
Title
ovulation rate
Description
when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone.
Time Frame
10-22 day of cycle
Title
Live birth rate
Description
total number of live births divided by total number of patients in a group
Time Frame
9 months
Title
Monofollicular development
Description
when only one follicle achieve diameter of greater than or equal to 18mm
Time Frame
10-12 day of menstrual cycle
Title
Multifollicular development
Description
when 2 or more follicles achieve diameter of >12mm
Time Frame
10-12 day of menstrual cycle
Title
Miscarraige
Description
spontaneous loss of pregnancy before 24 weeks of gestation
Time Frame
Less than 24weeks
Title
Adverse effects
Description
hot flushes.
Time Frame
first 10days of cycle
Title
Adverse effects
Description
Fatigue and dizziness
Time Frame
first 10days of cycle

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Services Institute of Medical sciences
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

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

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