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CompletedNCT06813118Updated May 7, 2026

Comparison of Clomid and Lezra With Lezra for Ovulation Induction in Clomid Resistant PCOS Case

A Phase 1 interventional study of Clomiphene Citrate and letrozole in Polycystic Ovarian Syndrome, sponsored by HITEC-Institute of Medical Sciences. Completed at 1 site in Pakistan. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by HITEC-Institute of Medical Sciences · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2024, registered Sep 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

Read the detailed description

Subfertility is characterized by the inability to achieve conception despite engaging in regular unprotected sexual intercourse for 1-2 years.PCOS exhibits chacteristic traits such as obesity,heightened insulin resistance accompanied by compensatory hyperinsulinemia,oligo/anovulation and subfertility.Clompiphene citrate induces ovarian stimulation.Letrozole ,an aromatase inhibitor emerges as a novel medication with comparable efficacy to CC as a first line treatment for inducing ovulation in cases of anovulation.

02

Conditions studied

  • Polycystic Ovarian Syndrome
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 42 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

HITEC-Institute of Medical Sciences is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Premature ovarian insufficiency
  • Husband has oligo azoospermia
  • Hypothyroidism
  • Hyperprolactinemia
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    group 1

    clomiphene citrate and letrozole combination

    Drug: Clomiphene Citrate and letrozole

  • Experimental
    group 2

    letrozole alone

    Drug: Clomiphene Citrate and letrozole

Interventions

  • DrugClomiphene Citrate and letrozole

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

    Also known as: drugs

06

What researchers measure

Primary outcomes

  1. To compare the rate of ovulation

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

    Time frame: 6 months

07

Study locations

1 site
  • HIT Hospital
    Rawalpindi, Punjab Province 47080, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06813118
Lead sponsor
HITEC-Institute of Medical Sciences
Responsible party
Rukhsana Shaheen Afzal (Assistant Professor, HITEC-Institute of Medical Sciences) — Principal investigator
First posted
Feb 6, 2025
Start date
Jun 7, 2024
Primary completion
Mar 25, 2025
Completion
Mar 25, 2025
Last update
May 7, 2026

Study contacts

Rukhsana Shaheen Afzal, MBBS,FCPS
principal investigator · HITEC-Institute of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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