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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Letrozole

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Multan, Punjab, Pakistan
      • Nishtar Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnosed cases of polycystic ovarian syndrome.

Exclusion Criteria:

• All women having endocrine disorders like thyroid disorders.
• Women having hyperprolactinemia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 to 16 days.

Collaborators and Investigators

• Sponsor: Nishtar Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: NishtarMU1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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