| CTRI Number |
CTRI/2023/08/056870 [Registered on: 24/08/2023] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [RCT] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Random Start Ovarian Stimulation for IVF |
|
Scientific Title of Study
|
Random Start Ovarian Stimulation Protocol Vs Conventional Early Follicular Phase Ovarian Stimulation in ART, A Multicenter Randomized Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IIHPL-UDR/RCT/003_2023 ver2.0 18_7_2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nihar Ranjan Bhoi |
| Designation |
Head Research and Academics |
| Affiliation |
Indira IVF Hospital Private Limited |
| Address |
Department of Reproductive Medicine,
44, Amar Niwas, kumharon ka Bhatta, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
917205783512 |
| Fax |
|
| Email |
drnihar.bhoi@indiraivf.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vipin Chandra |
| Designation |
Chief of Lab Operations |
| Affiliation |
Indira IVF Hospital Private |
| Address |
Department of Reproductive Medicine,
44, Amar Niwas, kumharon
ka Bhatta, Udaipur.
Udaipur
RAJASTHAN
313001
India |
| Phone |
919567971239 |
| Fax |
|
| Email |
drvipinchandra@indiraivf.in |
|
Details of Contact Person
Public Query
|
| Name |
Vipin Chandra |
| Designation |
Chief of Lab Operations |
| Affiliation |
Indira IVF Hospital Private |
| Address |
Department of Reproductive Medicine,
44, Amar Niwas, kumharon
ka Bhatta, Udaipur.
Udaipur
RAJASTHAN
313001
India |
| Phone |
919567971239 |
| Fax |
|
| Email |
drvipinchandra@indiraivf.in |
|
|
Source of Monetary or Material Support
|
| Indira IVF Hospital Private Limited
44, Amar Niwas Khumharo ka bhatta ,Udaipur |
|
|
Primary Sponsor
|
| Name |
Indira IVF Hospital Private Limited |
| Address |
44, Amar Niwas, kumharon ka Bhatta, Udaipur |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amol Lunkad |
Indira IVF Hospital |
Near Symbiosis College, New Airport, Road, Viman Nagar, Pune, Maharashtra
Pune
MAHARASHTRA |
8237834121
dramollunkad@indiraivf.in |
| Dr Anjali Jahlan |
Indira IVF Hospital |
41/2, Civil Lines, Near Hanuman Mandir, Lal Bahadur Shastri Marg, Prayagraj, Uttar Pradesh.
Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
9793116314
centerhead.allahabad@indiraivf.in |
| Dr Arvind Vaid |
Indira IVF Hospital |
Opposite Metro Pillar 203, Near Patel Nagar Metro Station, New Delhi - 110008, India
New Delhi
DELHI
New Delhi
DELHI |
9212274707
centerhead.delhi@indiraivf.in |
| Dr Dayanidhi Kumar |
Indira IVF Hospital |
4th floor, Kashyap business park, Raza Bazar, Bailey Road, Patna.
BIHAR
Patna
BIHAR |
9011803606
centerhead.patna@indiraivf.in |
| Dr Nihar Ranjan Bhoi |
Indira IVF Hospital |
44, Amar Niwas, kumharon ka Bhatta, Udaipur.
Udaipur
RAJASTHAN |
7205783512
drnihar.bhoi@indiraivf.in |
| Dr Nitasha Gupta |
Indira IVF Hospital |
Ground & First Floor, SCO, Sector 9 C madhya marg, Chandigarh - 160009
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
9988309211
centerhead.chandigarh@indiraivf.in |
| Dr Shyam Gupta |
Indira IVF Hospital |
rd floor, woody’s building, 45/1-1,17th main road, 2nd phase, JP Nagar, Bangalore – 560078
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9988309211
centerhead.chandigarh@indiraivf.in |
| Dr Tanu Batra |
Indira IVF Hospital |
Plot No. 3, Amrapali Circle, Vaishali Nagar, Jaipur (Raj.) - 302021
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
7742678300
centerhead.jprvaishali@indiraivf.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| IIHPL Ethics Committee Bangalore |
Submittted/Under Review |
| IIHPL Ethics Committee Chandigarh |
Approved |
| IIHPL Ethics Committee Delhi |
Submittted/Under Review |
| IIHPL Ethics Committee Jaipur |
Submittted/Under Review |
| IIHPL Ethics Committee Patna |
Submittted/Under Review |
| IIHPL Ethics Committee Prayagraj |
Submittted/Under Review |
| IIHPL Ethics Committee Pune |
Submittted/Under Review |
| IIHPL Ethics Committee Udaipur |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O090||Supervision of pregnancy with history of infertility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Ovarian Stimulation protocol |
ARM 1- Start of stimulation on Day 2/Day 3 of Cycle |
| Intervention |
Random start ovarian stimulation protocol Phase 1 |
ARM 2- Late Follicular Phase (Day 12- Day 14 of menstrual cycle) |
| Intervention |
Random start ovarian stimulation protocol Phase 2 |
ARM 3- Luteal Phase (Day 20 – Day 24 of menstrual cycle) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
37.00 Year(s) |
| Gender |
Female |
| Details |
1. Age- 25-37 years
2. BMI- 18.5-29.9 kg/m2
3. AMH -1.5 – 4.5 ngm/dl
4. AFC- 10-25
|
|
| ExclusionCriteria |
| Details |
1. Single ovary
2. Post Chemotherapy
3. Surgically retrieved sperm for ICSI
4. Thin Endo (<6mm on the day of transfer)
5. untreated hydrosalpinx (Communicating)
6. Male factor
o sperm count < 5 million/mL
o Surgically retrieved sperm
o DFI>25%
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to pregnancy |
On the day of β-hCG result |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Retrieval Rate |
On the day of OPU |
| Blast Rate |
5th -6th day of OPU |
| Total Usable Blast |
5 days after OPU |
| Clinical Pregnancy Rate |
4 weeks – 6 weeks after embryo transfer |
| Treatment Cost per embryo |
transfer cycle On day of embryo transfer |
| Time to Live Birth |
On day of Delivery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2023 |
| Date of Study Completion (India) |
27/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 prospective, open-label, multicentre, randomized,
parallel-group study will be conducted in women aged 25 to 37 years (both
inclusive), who are indicated to undergo COS as part of ART. Each woman will
participate in the study for a maximum duration of approximately 28 weeks after
signing the informed consent form (ICF). This will include a screening period,
a single cycle of COS and ART procedures, and post-ART follow-up for ongoing
pregnancy till 12 completed weeks of gestation.
The screening tests will be done as per the Schedule
of Assessments (SOA). The screening phase is planned for a maximum duration of
2 menstrual cycles, to allow time-specific assessments of the female
reproductive hormones, exclusion of pregnancy, confirmation of ovarian reserve,
and other suitable assessments to evaluate the subject’s eligibility.
Eligibility of the subject will be determined based on the results of all the
tests performed during the screening period, (reports of which should be
available with the investigator prior to initiation of COS.)
Once the participant is eligible to undergo
controlled ovarian stimulation, she will be randomized to either of 3 ARMS (ARM
1- Start of stimulation on Day 2/Day 3 Cycle, ARM 2- Late Follicular Phase (Start
of stimulation on Day 12- Day 14 of the menstrual cycle), ARM 3- Start of
stimulation on Luteal Phase (Day 20 – Day 24 of the menstrual cycle). |