CTRI

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CTRI Number

CTRI/2026/02/102738 [Registered on: 02/02/2026] Trial Registered Prospectively

Last Modified On:

30/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study in women with unruptured ectopic pregnancy comparing two medicines (letrozole and methotrexate) for avoiding surgery”

Scientific Title of Study

TO COMPARE EFFECT OF LETROZOLE VS METHOTREXATE FOR MEDICAL MANAGEMENT OF UNRUPTURED TUBAL ECTOPIC PREGNANCY

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Dr. Jidiya Chirag Harshadbhai
Designation	Secondary DNB Resident, Department of Obstetrics and Gynaecology
Affiliation	DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL
Address	Dr. Baba Saheb Ambedkar Hospital, Rohini, New Delhi, India DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL SECTOR-06, ROHINI, DELHI-85 North West DELHI 110085 India
Phone	9601032727
Fax
Email	chirag.gediya90@gmail.com

Details of Contact Person
Scientific Query

Name	Jidiya Chirag Harshadbhai
Designation	Secondary DNB Resident Doctor
Affiliation	DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL
Address	Dr.baba saheb ambedkar hospital,rohini 85,delhi DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL SECTOR-06, ROHINI, DELHI-85 North West DELHI 110085 India
Phone	9601032727
Fax
Email	chirag.gediya90@gmail.com

Details of Contact Person
Public Query

Name	Jidiya Chirag Harshadbhai
Designation	Secondary DNB Resident Doctor
Affiliation	DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL
Address	Dr.baba saheb ambedkar hospital,rohini 85,delhi DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL SECTOR-06, ROHINI, DELHI-85 North West DELHI 110085 India
Phone	9601032727
Fax
Email	chirag.gediya90@gmail.com

Source of Monetary or Material Support

Dr. Baba Saheb Ambedkar Hospital, Rohini, New Delhi, India

Primary Sponsor

Name	Dr Baba Saheb Ambedkar Hospital
Address	DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL SECTOR-06, ROHINI, DELHI-85
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	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 Jidiya Chirag Harshadbhai	Dr. Baba Saheb Ambedkar Hospital	Department of Obstetrics and Gynaecology, Dr. Baba Saheb Ambedkar Hospital, Sector-6, Rohini, New Delhi – 110085, India North West DELHI	9601032727 chirag.gediya90@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
The Institutional Ethics Committee of Dr. BSA Hospital & Medical College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O001\|\|Tubal pregnancy,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Letrozole	Tablet Letrozole 5 mg orally twice daily for 10 days for medical management of unruptured tubal ectopic pregnancy. Serum beta-hCG levels will be measured on Day 0, Day 4, Day 7 and Day 10.
Comparator Agent	Methotrexate	Single intramuscular dose of Methotrexate 50 mg/m² body surface area for medical management of unruptured tubal ectopic pregnancy. Serum beta-hCG levels will be measured on Day 0, Day 4, Day 7 and Day 10.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	45.00 Year(s)
Gender	Female
Details	Women diagnosed with unruptured tubal ectopic pregnancy. Hemodynamically stable patients. Serum beta human chorionic gonadotropin level less than or equal to 5000 milli international units per millilitre. Mean sac diameter less than three point five centimetres with no fetal cardiac activity on transvaginal ultrasound. Patients fulfilling criteria for medical management of unruptured ectopic pregnancy. Patients willing and able to comply with post treatment follow up. Patients having access to emergency medical services in case of clinical deterioration. Patients with no contraindication to Methotrexate and Letrozole. Patients with normal baseline hematological renal and hepatic laboratory parameters. Patients who have provided written informed consent.

ExclusionCriteria

Details

Ruptured ectopic pregnancy or signs of impending rupture.

Hemodynamically unstable patients.

Heterotopic pregnancy with coexisting viable intrauterine pregnancy.

Pregnancy of unknown location.

Presence of fetal cardiac activity in ectopic pregnancy.

Serum beta human chorionic gonadotropin level more than 5000 milli international units per millilitre.

Ectopic mass size equal to or more than three point five centimetres.

Patients with abnormal liver renal or hematological function.

Patients with immunodeficiency states.

Patients with active pulmonary disease including tuberculosis.

Patients with peptic ulcer disease.

Patients with known hypersensitivity to Methotrexate or Letrozole.

Patients unwilling or unable to comply with follow up protocol.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Change in serum beta human chorionic gonadotropin levels following medical management of unruptured tubal ectopic pregnancy.	Change in serum beta human chorionic gonadotropin levels following medical management of unruptured tubal ectopic pregnancy.

Secondary Outcome

Outcome	TimePoints
Need for surgical intervention following medical management of unruptured tubal ectopic pregnancy.	During treatment period and follow up until resolution of ectopic pregnancy.
Adverse effects related to letrozole and methotrexate.	During treatment period and follow up until completion of treatment.

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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)

10/02/2026

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="0"
Months="9"
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

Ectopic pregnancy is a significant cause of maternal morbidity. Medical management is preferred in hemodynamically stable women with unruptured tubal ectopic pregnancy. Methotrexate is the standard medical treatment but may be associated with adverse effects and contraindications. Letrozole has been proposed as an alternative medical therapy.

This study is a randomized parallel group active controlled clinical trial conducted at a tertiary care hospital in India. Women with unruptured tubal ectopic pregnancy who are hemodynamically stable are randomized to receive either oral Letrozole or intramuscular Methotrexate.

The primary outcome is the change in serum beta human chorionic gonadotropin levels following treatment. Secondary outcomes include the need for surgical intervention and adverse effects related to the study drugs. The study is currently open to recruitment.