Clincosm LogoSign in Get a demo

Efficacy of Letrozole Versus Clomiphene Citrate on Ovulation Induction in Patients With Polycystic Ovarian Syndrome

Sponsor
Nishtar Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05075863
Collaborator
(none)
78
Enrollment
1
Location
2
Arms
5.9
Actual Duration (Months)
13.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Letrozole Versus Clomiphene Citrate on Ovulation Induction in Patients With Polycystic Ovarian Syndrome
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Clomiphene Citrate

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.

Drug: Letrozole
Letrozole as 5mg from day 3 to 7 of menstrual cycle
Other Names:
  • Femara

    		•
    Experimental: Letrozole

    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.

    Drug: Letrozole
    Letrozole as 5mg from day 3 to 7 of menstrual cycle
    Other Names:
  • Femara

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Induction of ovulation was assessed by Transvaginal scan (TVS) [12 to 16 days.]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Diagnosed cases of polycystic ovarian syndrome.
    Exclusion Criteria:

    • All women having endocrine disorders like thyroid disorders.

    • Women having hyperprolactinemia.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nishtar Medical University Hospital Multan Punjab Pakistan

    Sponsors and Collaborators

    • Nishtar Medical University

    Investigators

    • Principal Investigator: Rashida Parveen, FCPS, Nishtar Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rashida Parveen, Consultant Gynecologist, Nishtar Medical University
    ClinicalTrials.gov Identifier:
    NCT05075863
    Other Study ID Numbers:
    • NishtarMU1
    First Posted:
    Oct 13, 2021
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome
    Letrozole

    Study Results

    No Results Posted as of Oct 14, 2021