Back to resultsEfficacy of Letrozole Versus Clomiphene Citrate on Ovulation Induction in Patients With Polycystic Ovarian Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Letrozole
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria:
- Diagnosed cases of polycystic ovarian syndrome.
Exclusion Criteria:
- All women having endocrine disorders like thyroid disorders.
- Women having hyperprolactinemia.
Sites / Locations
- Nishtar Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Clomiphene Citrate
Letrozole
Arm Description
A total of 39 women were given clomiphene citrate, 100mg from 3 to 7 days of menstrual cycle. All patients underwent transvaginal scan (TVS) so that efficacy could be evaluated (ovulation occurs on 14 day of menstrual cycle after a treatment of 5 days of both groups. Induction of ovulation was assessed by TVS. If follicle of >2cm is found on 12 days TVS and smaller/collapsed on 16 days TVS, ovulation induction was labeled.
A total of 39 women were given letrozole, 5mg from day 3 to 7 of menstrual cycle. All patients underwent transvaginal scan (TVS) so that efficacy could be evaluated (ovulation occurs on 14 day of menstrual cycle after a treatment of 5 days of both groups. Induction of ovulation was assessed by TVS. If follicle of >2cm is found on 12 days TVS and smaller/collapsed on 16 days TVS, ovulation induction was labeled.
Outcomes
Primary Outcome Measures
Induction of ovulation was assessed by Transvaginal scan (TVS)
Induction of ovulation was assessed by TVS. If follicle of >2cm is found on 12 days TVS and smaller/collapsed on 16 days TVS, ovulation induction was labeled
Secondary Outcome Measures
Full Information
NCT ID
NCT05075863
First Posted
September 28, 2021
Last Updated
October 12, 2021
Sponsor
Nishtar Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05075863
Brief Title
Efficacy of Letrozole Versus Clomiphene Citrate on Ovulation Induction in Patients With Polycystic Ovarian Syndrome
Official Title
Efficacy of Letrozole Versus Clomiphene Citrate on Ovulation Induction in Patients With Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nishtar Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
We aimed this study to determine and compare frequency of induction of ovulation in women with polycystic ovarian syndrome treated with Letrozole versus clomiphene citrate as published literature shows variations.
Detailed Description
Discrepancy between ovulation induction rate and pregnancy rate is related to anti-estrogenic effects on cervical mucus and endometrium and long acting gonadotrophins are more effective than clomiphene citrate. This study was aimed at comparing frequency of induction of ovulation in women with polycystic ovarian syndrome treated with Letrozole versus clomiphene citrate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clomiphene Citrate
Arm Type
Experimental
Arm Description
A total of 39 women were given clomiphene citrate, 100mg from 3 to 7 days of menstrual cycle. All patients underwent transvaginal scan (TVS) so that efficacy could be evaluated (ovulation occurs on 14 day of menstrual cycle after a treatment of 5 days of both groups. Induction of ovulation was assessed by TVS. If follicle of >2cm is found on 12 days TVS and smaller/collapsed on 16 days TVS, ovulation induction was labeled.
Arm Title
Letrozole
Arm Type
Experimental
Arm Description
A total of 39 women were given letrozole, 5mg from day 3 to 7 of menstrual cycle. All patients underwent transvaginal scan (TVS) so that efficacy could be evaluated (ovulation occurs on 14 day of menstrual cycle after a treatment of 5 days of both groups. Induction of ovulation was assessed by TVS. If follicle of >2cm is found on 12 days TVS and smaller/collapsed on 16 days TVS, ovulation induction was labeled.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
Letrozole as 5mg from day 3 to 7 of menstrual cycle
Primary Outcome Measure Information:
Title
Induction of ovulation was assessed by Transvaginal scan (TVS)
Description
Induction of ovulation was assessed by TVS. If follicle of >2cm is found on 12 days TVS and smaller/collapsed on 16 days TVS, ovulation induction was labeled
Time Frame
12 to 16 days.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosed cases of polycystic ovarian syndrome.
Exclusion Criteria:
All women having endocrine disorders like thyroid disorders.
Women having hyperprolactinemia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rashida Parveen, FCPS
Organizational Affiliation
Nishtar Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nishtar Medical University Hospital
City
Multan
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Letrozole Versus Clomiphene Citrate on Ovulation Induction in Patients With Polycystic Ovarian Syndrome
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