| CTRI Number |
CTRI/2024/02/063171 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [rTMS (Repetitive transcranial magnetic stimulation):Non invasive brain stimulation] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study evaluating the effect of rTMS in infertile women with moderate to severe depression |
|
Scientific Title of Study
|
Does rTMS Repetitive transcranial magnetic stimulation improve the outcome of in vitro fertilization in infertile women with moderate to severe depression |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kataru Nikitha |
| Designation |
Junior resident OBG (Academic) |
| Affiliation |
AIIMS, New Delhi |
| Address |
IVF Lab, Service floor, ART centre, Department of Obstetrics and Gynaecology, Mother and Child Block, AIIMS Delhi, 110049
New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9393127287 |
| Fax |
|
| Email |
knikithavizag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Neeta Singh |
| Designation |
Professor (Obstetrics and Gynaecology) |
| Affiliation |
AIIMS, New Delhi |
| Address |
IVF Lab, Service floor, ART centre, Department of Obstetrics and Gynaecology, Mother and Child Block, AIIMS Delhi, 110049
New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9818506855 |
| Fax |
|
| Email |
drneetasingh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kataru Nikitha |
| Designation |
Junior resident OBG (Academic) |
| Affiliation |
AIIMS, New Delhi |
| Address |
IVF Lab, Service floor, ART centre, Department of Obstetrics and Gynaecology, Mother and Child Block, AIIMS Delhi, 110049
New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9393127287 |
| Fax |
|
| Email |
knikithavizag@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS Delhi |
| Address |
All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Kataru Nikitha |
AIIMS Delhi |
IVF Lab, Service floor, ART centre, Department of Obstetrics and Gynaecology, Mother and Child Block, AIIMS Delhi, 110049
New Delhi
DELHI |
9393127287
knikithavizag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N97||Female infertility, (2) ICD-10 Condition: F33||Major depressive disorder, recurrent, (3) ICD-10 Condition: F32||Major depressive disorder, singleepisode, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
rTMS (Repetitive transcranial magnetic stimulation) |
Neuromodulation technique that uses a magnetic field to stimulate focal cortical brain regions with electrical currents given for 3 min 9 sec each session, comprising of 15 sessions, 1 session per day Monday to Friday over 3 weeks. |
| Comparator Agent |
Sham rTMS (Repetitive transcranial magnetic stimulation) |
Mimics the sound and feel of active treatment but does not activate the brain in the possibly therapeutic manner given for 3 min 9 sec each session, comprising of 15 sessions, 1 session per day Monday to Friday over 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Women undergoing IVF at ART center & willing to participate
2. Moderate to severe depression
|
|
| ExclusionCriteria |
| Details |
Comorbid psychiatric illness
Substance abuse including nicotine
Any other contraindication for rTMS
Women with moderate to severe depression opting for pharmacotherapy
Donor Recipient cycles
Severe OATS (Oligoasthenoteratozoospermia)
Oncofertility
Hyper-responders like PCOS undergoing segmented Embryo Transfer
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of rTMS on the clinical pregnancy rate in infertile women with depression undergoing IVF-Fresh ET |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess depression measured using HAM-D questionnaire pre and post rTMS |
3 weeks |
| To assess the biochemical levels (Cortisol, BDNF) pre and post rTMS |
3 weeks |
| Oocyte and Embryo quality |
6 weeks |
| Implantation success by measuring Beta HCG levels |
7 weeks |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/02/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 is a pilot randomized, parallel group, placebo controlled trial studying the effect of rTMS (Repetitive transcranial magnetic stimulation) on the reproductive outcome in 40 infertile women with moderate to severe depression undergoing IVF cycles at ART centre, Department of Obstetrics and Gynaecology. The primary outcome measures the effect of rTMS on the clinical pregnancy rate in infertile women with depression undergoing IVF-Fresh ET cycles at 8 weeks. The secondary outcomes will be to assess depression measured using HAM-D questionnaire at 3 weeks, serum cortisol and BDNF levels at 3 weeks, oocyte and embryo quality at 6 weeks and implantation success by measuring Beta HCG level at 7 weeks. |