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

NCT05075863 | Completed

• 1 other identifier: NishtarMU1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Clomiphene Citrate

EXPERIMENTAL

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

EXPERIMENTAL

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

Interventions

Letrozole DRUG

Letrozole as 5mg from day 3 to 7 of menstrual cycle

Also known as: Femara

Clomiphene Citrate; Letrozole

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed cases of polycystic ovarian syndrome.

You may not qualify if:

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

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Medical University Hospital

Multan, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rashida Parveen, FCPS

  Nishtar Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gynecologist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 13, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)