| CTRI Number |
CTRI/2017/10/010176 [Registered on: 24/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
23/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of heparin in recurrent implantation failures in IVF |
|
Scientific Title of Study
|
Luteal phase low molecular weight heparin in fresh non donor IVF/ICSI cycles in women with previous failed fresh IVF/ICSI cycles |
| Trial Acronym |
HepRIF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeta Singh |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Department of obstetrics and Gynecology
AIIMS
Ansari nagar
New delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drneetasingh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohitha C |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Department of obstetrics and gynecology
AIIMS
Ansari nagar
New delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
redruby9191@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohitha C |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Department of obstetrics and gynecology
AIIMS
Ansari nagar
New delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
redruby9191@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of medical sciences, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
All india institute of medical sciences |
| Address |
Ansari nagar
New Delhi
110029 |
| 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 Rohitha |
All India Institute Of Medical Sciences |
Department Of Obstetrics & Gynecology
Ansari nagar
New Delhi - 110029
South
DELHI |
9958180604
redruby9191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee for post graduate research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
INFERTILITY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL GROUP |
Those who meet the inclusion criteria of the study and not receiving the drug |
| Intervention |
heparin |
Those who meet inclusion criteria of the study and receive the drug
Inj low molecular weight heparin 1mg/kg/day
duration - 6 weeks if UPT negative
36 weeks if UPT positive |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
Women requiring anticoagulant therapy for other medical reasons
Obvious causes of implantation failure (hydrosalpinx visible on transvaginal ultrasound, fibroids distorting the uterine cavity, the absence of Grade I or Grade II embryos available for transfer)
Clinical or laboratory findings of congenital or acquired thrombophilia.
Severe male factor infertility requiring sperm retrievals. |
|
| ExclusionCriteria |
| Details |
1.women requiring anticoagulant therapy
2.obvious causes of implantation failure (untreated hydrosalpinx, fibroids, absence of grade 1 or grade 2 embryos available for transfer
3. clinical or laboratory findings of congenital or acquired thrombophilia
4. severe male factor infertility requiring surgical sprem retrievals |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Implantation rate per embryo transfer
clinical pregnancy rate |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ongoing pregnancy rate |
20 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/11/2015 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective randomised controlled trial being conducted in ART centre of AIIMS, NEW DELHI INDIA with a sample size of 100 infertility patients (50 cases + 50 controls ). Primary purpose of study is to improve rates of conception by crossing the crucial rate limiting step of implantation. Implantation failure has been attributed to many factors and being itself a complicated process. Several lines of evidence from invivo and invitro studies suggest a beneficial effect of heparin on embryo implantation through interactions with several adhesion molecules, growth factors , cytokines and matrix metalloproteinases. so here is an effort to assess possible beneficial effect of low molecular weight heparin in previously failed IVF/ICSI cycles |