CTRI

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CTRI Number

CTRI/2025/12/099866 [Registered on: 26/12/2025] Trial Registered Prospectively

Last Modified On:

25/12/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparing two fertility medicine approaches to help ovulation in women with polycystic ovary syndrome who are unable to conceive.

Scientific Title of Study

A Randomized controlled trial of combination letrozole plus clomiphene citrate and letrozole alone for ovulation induction in infertile women with polycystic ovary syndrome.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Komal
Designation	Postgraduate resident
Affiliation	AIIMS JODHPUR
Address	Department of obstetrics and gynaecology,Academic block third floor,Room no.3096,AIIMS JODHPUR Jodhpur RAJASTHAN 342005 India
Phone	6350157319
Fax
Email	komalbshn@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Manu Goyal
Designation	Additional Professor
Affiliation	AIIMS JODHPUR
Address	Department of Obstetrics and Gynaecology,Academic block third floor,Room no.3096 ,AIIMS JODHPUR Jodhpur RAJASTHAN 342005 India
Phone	9971833603
Fax
Email	drmanu_8@yahoo.co.in

Details of Contact Person
Public Query

Name	Dr Manu Goyal
Designation	Additional Professor
Affiliation	AIIMS JODHPUR
Address	Department of obstetric and Gynaecology ,Academic block third floor,Room no.3096,AIIMS JODHPUR Jodhpur RAJASTHAN 342005 India
Phone	9971833603
Fax
Email	drmanu_8@yahoo.co.in

Source of Monetary or Material Support

AIIMS JODHPUR Pin code 342005,India

Primary Sponsor

Name	Dr Komal
Address	Department of Obstetrics and Gynaecology,Academic block third floor,Room no.3096 ,AIIMS Jodhpur,Pin code 342005,India
Type of Sponsor	Other [self]

Details of Secondary Sponsor

Name	Address
NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Komal	AIIMS JODHPUR	Department of Obstetrics and Gynaecology , Medical college , AIIMS JODHPUR , JODHPUR , RAJASTHAN Jodhpur RAJASTHAN	6350157319 komalbshn@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
AIIMS JODHPUR Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N970\|\|Female infertility associated withanovulation, (2) ICD-10 Condition: Z331\|\|Pregnant state, incidental,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Letrozole	Women will receive 2.5 mg letrozole alone from cycle day 3-7
Intervention	Letrozole plus clomiphene citrate	Women will receive a combination of 2.5 mg letrozole daily and 50 mg clomiphene citrate on day 3-7 of cycle

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Female
Details	Women aged 18-40 years diagnosed with PCOS based on Rotterdam criteria(must meet 2 out of 3) -Oligo/anovulation -Clinical and/or biochemical signs of hyperandrogenism -Polycystic ovaries on ultrasound (more than 12 follicles in ovary 2-Infertility for at least 12 months 3-Normal semen analysisnof male partner 4-Willlingness to provide informed consent

ExclusionCriteria

Details

1-Pregnancy
2-Current hormonal contraception use
3-Uncorrected thyroid disease
4-Untreated hyperprolactinemia
5-Uncontrolled type1 and 2 DM
6-Hypertension
7-Allergy or contraindications to letrozole or CC
8-Clinical suspicion of other etiologies that mimics PCOS like androgen secreting tumors

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Primary outcome measure is ovulation rate which is Indicated by mid luteal progesterone level more than 3 ng per mL	2 years

Secondary Outcome

Outcome	TimePoints
Size and number of developing follicles on serial USG between D10 to 16	2 years
Endometrial thickness on cycle day 12 to 16 on ultrasound	2 years
Adverse events related to the study medications like OHSS	2 years
Conception or pregnancy rate a positive serum or urinary test of hCG	2 years

Target Sample Size

Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 4

Date of First Enrollment (India)

10/01/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Open to Recruitment

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Infertility is a common reproductive health problem, with polycystic ovary syndrome being the leading cause of anovulatory infertility in women of reproductive age. Ovulation induction remains the cornerstone of infertility management in polycystic ovary syndrome. Letrozole is currently recommended as the first line agent for ovulation induction, while clomiphene citrate, previously the standard therapy, is now used as a second line or adjunctive agent. Although both drugs act by reducing estrogen mediated negative feedback on the hypothalamic pituitary axis, they differ in their mechanisms of action and effects on the endometrium and follicular development.

Several studies suggest that combining letrozole and clomiphene citrate may improve ovulation rates compared to letrozole alone, however, existing evidence is limited and inconsistent. This randomized controlled study is designed to compare the effectiveness of combination therapy (letrozole plus clomiphene citrate) versus letrozole alone for ovulation induction in infertile women with polycystic ovary syndrome.

Eligible women aged 18 to 40 years diagnosed with polycystic ovary syndrome according to Rotterdam criteria and with at least one patent fallopian tube and normal partner semen parameters will be randomized into two groups. Group I will receive letrozole 2.5 mg plus clomiphene citrate 50 mg daily from cycle day 3 to day 7, while Group 2 will receive letrozole 2.5 mg alone for the same duration. Participants will be monitored with serial transvaginal ultrasonography for follicular development and endometrial thickness. Ovulation will be confirmed by mid luteal serum progesterone levels more than 3 ng per mL. Pregnancy will be assessed by serum or urine B hCG testing.

The primary outcome is ovulation rate. Secondary outcomes include number and size of dominant follicles, endometrial thickness, pregnancy rate, and incidence of adverse events such as ovarian hyperstimulation syndrome.

This study aims to determine whether combination therapy offers superior ovulation outcomes compared to letrozole alone, while maintaining safety and cost effectiveness, potentially providing an alternative to more invasive and expensive second line treatments.