| CTRI Number |
CTRI/2025/02/079849 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between Methotrexate and Letrozole in the management of unruptured ectopic pregnancy |
|
Scientific Title of Study
|
Methotrexate Vs Letrozole in the medical management of unruptured ectopic pregnancy-a comparative study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meghasriti |
| Designation |
Post graduate trainee |
| Affiliation |
Guwahati Medical College, Guwahati |
| Address |
Department of Obstetrics and Gynaecology,Guwahati Medical College and Hospital, Guwahati,ASSAM-781032
Kamrup
ASSAM
781032
India |
| Phone |
09863665606 |
| Fax |
|
| Email |
sritimeghasriti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Gitanjali Deka |
| Designation |
Professor |
| Affiliation |
Guwahati Medical College, Guwahati |
| Address |
Department of Obstetrics and Gynaecology, Guwahati, Assam-781032
Kamrup
ASSAM
781032
India |
| Phone |
9864094184 |
| Fax |
|
| Email |
gitanjali.dk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Gitanjali Deka |
| Designation |
Professor |
| Affiliation |
Guwahati Medical College, Guwahati |
| Address |
Department of Obstetrics and Gynaecology, Guwahati Medical College, Guwahati, Assam
Kamrup
ASSAM
781032
India |
| Phone |
9864094184 |
| Fax |
|
| Email |
gitanjali.dk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guwahati Medical College and Hospital, Guwahati, Assam, India PIN 781006 |
|
|
Primary Sponsor
|
| Name |
Meghasriti |
| Address |
Department of Obstetrics and Gynaecology, Guwahati Medical College, Guwahati, Assam PIN-781032 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meghasriti |
Guwahati Medical College |
Department of Obstetrics and Gynaecology, Guwahati Medical College, Guwahati, Assam-781032
Kamrup
ASSAM |
09863665606
sritimeghasriti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,GAUHATI MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O009||Ectopic pregnancy, unspecified, (2) ICD-10 Condition: O008||Other ectopic pregnancy, (3) ICD-10 Condition: O002||Ovarian pregnancy, (4) ICD-10 Condition: O001||Tubal pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Letrozole |
Name letrozole
Dose 10 MG in two divided doses
Duration Beta hCG is seen on day 4 and day 7 and if the fall is by 15 percent then weekly follow up till complete resolution.
Route of Administration oral
Expected Outcome is resolution of ectopic pregnancy indicated by a drop in beta hCG levels
if at any given time patients vitals are deteriorating or there is significant pain abdomen or there is increase in beta hCG then other means of termination is adopted |
| Comparator Agent |
Methotrexate |
Name Methotrexate
Dose 50 mg per metre square intramuscularly
Duration hCG will be assessed on day 4 and day 7 and if the fall is by 15 percent then weekly follow up till complete resolution.
Route of Administrationis Intramuscular
Expected Outcome is Resolution of ectopic pregnancy indicated by a drop in beta hCG levels
if at any given time patients vitals are deteriorating or there is significant pain abdomen or there is increase in beta hCG then other means of termination may be adopted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Ectopic pregnancy confirmed by physician. Serum beta HCG less than 3000 mIU/mL. Adnexal mass less than 35 mm with cardiac activity or less than 40 mm without cardiac activity. Patient is hemodynamically stable. |
|
| ExclusionCriteria |
| Details |
Intrauterine pregnancy
Beta HCG more than 5000 MIU/ML
Ruptured ectopic pregnancy
Unruptured ectopic pregnancy with significant pain |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the resolution of ectopic pregnancy by estimating serum human chorionic gonadotropin (beta hCG) levels below 5mIU/mL |
4th day of administration of either drug followed by 7th day of administration.
If the decline between 4th and 7th day is more or equal to 15 percent then weekly monitoring of bhcg will be done till it comes down to less the 5 mIU/ml |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in ovarian reserve antimullerian hormone AMH & hematologic changes (CBC, LFT)associated with the two medical treatments. |
AMH, LFT AND CBC will be recorded on the following time points
0 day- on the day of administration of either drug
After 1 month
After 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/02/2025 |
| 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="1"
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
|
This study aims to show the great promise letrozole holds for the treatment of ectopic pregnancy. Methotrexate has been a medical alternative to surgery for some time. But as an antimetabolite and immune suppressant chemotherapeutic drug methotrexate comes with toxic effects that may threaten a patients health and future fertility. Hence this trial is done to give an alternative drug that can be used in place of methotrexate as a standard treatment for medical management of unruptured ectopic pregnancy My randomized prospective cohort study will include women with undisturbed ectopic pregnancy who have no contraindications to methotrexate or letrozole treatment. The study will have two groups comprising women who will receive medical treatment with methotrexate group 1 and the other group recieving letrozole group 2. A comparision will be drawn between the two drugs on the basis of the results obtained. |