| CTRI Number |
CTRI/2013/02/003406 [Registered on: 18/02/2013] Trial Registered Retrospectively |
| Last Modified On: |
18/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of uterine blood flow, following two types of progesterone in recurrent miscarriage |
|
Scientific Title of Study
|
Assessment of sub-endometrial blood flow parameters following dydrogesterone and micronized vaginal progesterone administration in women with idiopathic recurrent spontaneous miscarriage |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Baidyanath Chakravarty |
| Designation |
Director |
| Affiliation |
Institute of Reproductive Medicine |
| Address |
11/11A, Block - L, Flat - 1A, Mayfair Road, Kolkata
HB-36/A/3, Sector - III, Salt Lake City, Kolkata, West Bengal
North Twentyfour Parganas
WEST BENGAL
700019
India |
| Phone |
03323215125 |
| Fax |
|
| Email |
bncirm@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baidyanath Chakravarty |
| Designation |
Director |
| Affiliation |
Institute of Reproductive Medicine |
| Address |
HB-36/A/3, Sector - III, Salt Lake City, Kolkata, West Bengal
HB-36/A/3, Sector - III, Salt Lake City, Kolkata, West Bengal
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
03323215125 |
| Fax |
|
| Email |
bncirm@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Baidyanath Chakravarty |
| Designation |
Director |
| Affiliation |
Institute of Reproductive Medicine |
| Address |
HB-36/A/3, Sector - III, Salt Lake City, Kolkata, West Bengal
HB-36/A/3, Sector - III, Salt Lake City, Kolkata, West Bengal
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
03323215125 |
| Fax |
|
| Email |
bncirm@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Reproductive Medicine |
|
|
Primary Sponsor
|
| Name |
Institute of Reproductive Medicine |
| Address |
HB-36/A/3, Sector - III, Salt Lake City, Kolkata |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Baidyanath Chakravarty |
USG Department (Institute of Reproductive Medicine) |
HB-36/A/3, Sector - III, Salt Lake City, Kolkata
North Twentyfour Parganas
WEST BENGAL |
03323215125
bncirm@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, IRM, HB-36/A/3, Salt Lake, Kolkata - 700106 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with history of three or more miscarriages, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dydrogesterone |
10mg twice daily - orally, upto 14 weeks of gestation |
| Intervention |
Micronised Progesterone |
100mg thrice daily - vaginally, upto 14 weeks of gestation |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients with three or more consecutive miscarriages
up to 12 weeks of gestation followed by
spontaneous conception, no apparent cause of recurrent pregnancy loss |
|
| ExclusionCriteria |
| Details |
Diabetes Mellitus, Luteal Phase Defect, Hypothyroidism, Hyperprolactinemia, Hyperhomocysteinemia, Uterine Defects |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ongoing Pregnancy/Live Birth
Endometrial Blood Flow |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Miscarriage Rate |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="101"
Sample Size from India="101"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2011 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No Data Published as yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective clinical study is being conducted at Institute of Reproductive Medicine, Kolkata, India. The aim is to evaluate differences in utero-placental blood flow and pregnancy outcome in women with Recurrent Spontaneous Miscarriage following administration of two types of progestins viz. micronised vaginal progsterone and oral dydrogesterone. 101 women who have had three or more consecutive miscarriages within first trimester, followed by spontaneous conception, are participating in this study. Endometrial blood flow parameters by Doppler indices and ongoing pregnancy rates are being studied.
|