NCT06813118

Brief Summary

Clomiphene citrate resistant i.e failure to ovulate after 6 cycles of ovulation induction effects 15-40% of patients with PCOS.Two treatment groups will be formed one recieving letrozole alone and another recieving CC and letrozole combined.Mature follicles and endometrial thickness will be checked by transvaginal ultrasound and results will be recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2024

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

June 7, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

September 13, 2024

Last Update Submit

May 4, 2026

Conditions

Polycystic Ovarian Syndrome

Outcome Measures

Primary Outcomes (1)

  • To compare the rate of ovulation

    To compare the rate of ovulation between letrozole alone and letrozole and CC

    6 months

Study Arms (2)

group 1

EXPERIMENTAL

clomiphene citrate and letrozole combination

Drug: Clomiphene Citrate and letrozole

group 2

EXPERIMENTAL

letrozole alone

Drug: Clomiphene Citrate and letrozole

Interventions

Clomiphene Citrate and letrozoleDRUG

clomiphene citrate 100mg once daily along with letrozole 5mg to one group and letrozole 5mg to second group

Also known as: drugs
group 1group 2

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women of 20-40 years with a history of PCOS and resistant to CC

You may not qualify if:

  • Premature ovarian insufficiency
  • Husband has oligo azoospermia
  • Hypothyroidism
  • Hyperprolactinemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIT Hospital

Rawalpindi, Punjab Province, 47080, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

ClomipheneLetrozolePharmaceutical Preparations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsNitrilesTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Rukhsana Shaheen Afzal, MBBS,FCPS

    HITEC-Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
lottery method for selection
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomization intervention RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2024

First Posted

February 6, 2025

Study Start

June 7, 2024

Primary Completion

March 25, 2025

Study Completion

March 25, 2025

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)