NCT05702957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

3.1 years

First QC Date

December 8, 2022

Last Update Submit

January 18, 2023

Conditions

Polycystic Ovary SyndromeInfertility

Keywords

polycystic ovary syndromeInfertilityClomiphene citrateLetrozole

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    Total number of patients conceived after treatment

    5th week of cycle when periods missed

Secondary Outcomes (7)

  • ovulation rate

    10-22 day of cycle

  • Live birth rate

    9 months

  • Monofollicular development

    10-12 day of menstrual cycle

  • Multifollicular development

    10-12 day of menstrual cycle

  • Miscarraige

    Less than 24weeks

  • +2 more secondary outcomes

Study Arms (2)

letrozole

EXPERIMENTAL

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

Drug: letrozole 2.5mg-7.5mg

Clomiphene citrate

ACTIVE COMPARATOR

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

Drug: Clomiphene Citrate 50mg-150mg

Interventions

letrozole 2.5mg-7.5mgDRUG

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

Also known as: tab lezra 2.5-7.5mg
letrozole
Clomiphene Citrate 50mg-150mgDRUG

Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.

Also known as: tab clomid 50-150mg
Clomiphene citrate

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women age between 18-40 years.
  • Normal husband semen analysis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Institute of Medical sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Wasim T, Nasrin T, Zunair J, Irshad S. Efficacy of Letrozole vs Clomiphene Citrate for induction of ovulation in women with polycystic ovarian syndrome. Pak J Med Sci. 2024 Jan-Feb;40(1Part-I):78-83. doi: 10.12669/pjms.40.1.7971.

    PMID: 38196458DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility

Interventions

LetrozoleClomiphene

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Obstetrics & Gynaecology

Study Record Dates

First Submitted

December 8, 2022

First Posted

January 27, 2023

Study Start

September 1, 2016

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

January 27, 2023

Record last verified: 2023-01

Locations

PA(1)