| CTRI Number |
CTRI/2018/07/014934 [Registered on: 18/07/2018] Trial Registered Prospectively |
| Last Modified On: |
17/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of two different drugs on endometrial thickness and pregnancy rate in infertile women: A cross- over study |
|
Scientific Title of Study
|
To compare the effect of Sildenafil citrate and granulocyte- colony stimulating factor (G-CSF) on endometrial thickness in infertile women: A cross- over study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mukta Agarwal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of Obstetrics & Gynaecology, AIIMS, Patna
Q NO 111,T4, B1, AIIMS Residential Complex, Khagaul, Patna- 801105
Patna
BIHAR
801507
India |
| Phone |
9661215080 |
| Fax |
|
| Email |
agarwal_mukta2006@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mukta Agarwal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of Obstetrics & Gynaecology, AIIMS, Patna
Q NO 111,T4, B1, AIIMS Residential Complex, Khagaul, Patna- 01105
Patna
BIHAR
801507
India |
| Phone |
9661215080 |
| Fax |
|
| Email |
agarwal_mukta2006@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mukta Agarwal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of Obstetrics & Gynaecology, AIIMS, Patna- 801507
Q NO 111,T4, B1, AIIMS Residential Complex, Khagaul, Patna- 801105
Patna
BIHAR
801507
India |
| Phone |
9661215080 |
| Fax |
|
| Email |
agarwal_mukta2006@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| AIIMS, Patna (Institutional) |
|
|
Primary Sponsor
|
| Name |
Department of Obstetrics Gynaecology AIIMS Patna |
| Address |
Department of Obstetrics & Gynaecology, AIIMS, Patna- 801507 |
| 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 Mukta Agarwal |
usg & procedure room, room no. 8-c, deptt. of obs & gynae |
AIIMS, patna
Patna
BIHAR |
91-9661215080
agarwal_mukta2006@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
INFERTILE WOMEN WITH NO OTHER MEDICAL CO-MORBIDITY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
granulocyte- colony stimulating factor |
2 mg intra-uterine instillation on day 2 of menstrual cycle(single administration) |
| Intervention |
tab sildenafil |
50 mg daily per orally from day 2 of menstrual cycle till day of ovulation trigger |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Female |
| Details |
: infertile females attending gynaecology OPD,where other causes of infertility had been ruled out ( including male factor infertility, tubal factor, decreased ovarian reserve and tuberculosis) and patients with unexplained infertility with thin endometrium undergoing ovulation induction, who in previous cycle had already received estrogen supplementation and not benifitted much, will be enrolled for the study after taking informed consent |
|
| ExclusionCriteria |
| Details |
1. Pt with husband factor, tubal factor or with poor ovrian reserve
2. Known hypersensitivity to the drug
3. Pts on any anti-anginal or antihypertensive drugs
4. Pts. With known liver disorders
5. Pts. With known kidney disorders
- Pts. With heart disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| endometrial thickness on the day of trigger |
on day of inj HCG |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Endometrial pattern( trilaminar)
2. chemical pregnancy rate
3. pregnancy rate
4. delivery rate
|
day 20 after inj HCG |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/08/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIIMS & OBJECTIVES: to assess effect of sildenafil & G- CSF on endometrial thickness. 2. to know overall pregnancy and delivery rates in each group material & methods: infertile women attending G-OPD for infertility, who in previous cycle had received estrogen for poor endometrial thickness, but not benitted much, will be enrolled in the study after ruling out exclusion criteria and obtaining informed consent. pt. will be divided in two groups- one group will receive tab sildenafil 50 mg per orally fro day 2 of cycle till the day of HCG trigger along with tab estrogen 4 mg daily in divided doses, 2nd group will receive intra0uterine instillation of G- CSF on the day- 3 of menstrual cycle along eith estrogen. the endometrial thickness for both the groups will be compared with the endometrial thickness with estrogen alone. pregnancy and delivery rates will also be compared |