| CTRI Number |
CTRI/2024/03/064504 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Progesterone based stimulation with conventional protocol during the luteal phase of menstrual cycle in poor ovarian responders undergoing dual stimulation (DuoStim) |
|
Scientific Title of Study
|
Progesterone-primed versus conventional antagonist stimulation during the luteal phase in poor ovarian responders undergoing Duo-Stim
protocol- a pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neena Malhotra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Obstetrics and Gynecology
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
9891557707 |
| Fax |
|
| Email |
malhotraneena@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neena Malhotra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Obstetrics and Gynecology
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9891557707 |
| Fax |
|
| Email |
malhotraneena@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Snigdha Soni |
| Designation |
DM Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Obstetrics and Gynecology
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
8800134300 |
| Fax |
|
| Email |
snigdha398@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar (East), 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 Snigdha Soni |
All India Institute of Medical Sciences |
ART Centre,Department of Obstetrics and Gynecology, Mother and Child Block AIIMS New Delhi
New Delhi
DELHI |
8800134300
snigdha398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research, All India Institute of Medical Sciences,Ansari Nagar, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GnRH Antagonist |
GnRH antagonist has been conventionally used to suppress LH surge in the patients undergoing ovarian stimulation. It will be started during ovarian stimulation when the lead follicle is between 12-14mm and continued until the day of the trigger |
| Intervention |
Oral Progesterone |
Oral progesterone ( Medroxyprogesterone acetate) will be used to suppress LH surge in patients undergoing ovarian stimulation in the luteal phase. It will be started during ovarian stimulation when the lead follicle is between 12-14mm and continued until the day of the trigger |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women with defined decreased ovarian reserve before stimulation: Patients meeting any two of the following criteria: Age greater than 35 years, AMH less than 1.2, AFC less than 5
Unexpected poor response ,despite normal ovarian reserves, to ovarian stimulation in previous cycles: Less than 4 oocytes retrieved in previous IVF/ICSI cycles
Unexpected suboptimal response, despite normal ovarian reserves, to ovarian stimulation in previous cycles: 4to 9 oocytes retrieved in previous IVF ICSI cycles
Willing to participate in the study
Women meeting the above-mentioned criteria and having at least two follicles in each ovary between 2-8 mm at the time of ovum pickup after follicular stimulation, will be taken up for subsequent luteal phase stimulation. |
|
| ExclusionCriteria |
| Details |
Diagnosed PCOS
Severe male factor infertility,requiring surgical sperm retrieval or severe OATS
Donor Recipient Cycles
BMI less than 19 kg/m2 or greater than 30 kg/m2
Any history of genital tuberculosis
Unwilling to participate in the study
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of oocytes retrieved
Number of Metaphase-II (M-II) oocytes retrieved
|
Baseline (On the day of ovum pickup)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total dose of gonadotropins required
Duration of controlled ovarian stimulation
Serum estradiol (E2) & progesterone (P4) on the day of trigger
Fertilization Rate
Cleavage Rate
Blastulation Rate
Cycle cancellation rate
Clinical Pregnancy Rate per embryo transfer
Cumulative clinical pregnancy rate
Cumulative live birth rate (CLBR)
|
Total dose of gonadotropins required,
Duration of controlled ovarian stimulation,
Serum estradiol (E2) & progesterone (P4) on the day of trigger will be assessed at baseline.
Fertilization Rate,Cleavage Rate,Blastulation Rate,Cycle cancellation rate will be assessed at a single time point on day 5/day 6 post ovum pickup
Clinical pregnancy rate will be assessed 6-8 weeks after embryo transfer
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2024 |
| 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
|
Controlled ovarian stimulation (COS) is a crucial step in the success of an in vitro fertilization-embryo transfer (IVF-ET) cycle. Theoretically, the possibility of increasing the number of the oocytes retrieved per attempt could result in a higher chance of obtaining a reproductively competent embryo, thus improving the cumulative live birth rate. Despite the recent advances in techniques of COS, the estimated prevalence of poor responders, according to the POSEIDON criteria, is around 40%. Several strategies have been proposed, aiming to maximise ovarian response and success in these patients; however, no standard management has been outlined yet. One such strategy is double stimulation or DuoStim, which proposes ongoing stimulation in the luteal phase immediately following egg retrieval after stimulation in the follicular phase of the same menstrual cycle. This is based on the evidence that multiple follicular waves can arise in a single ovarian cycle in humans. There is a definite need to block the LH surges during the luteal phase of stimulation as well which can be materialized using the standard GnRH antagonist or, lately, using Progestins, which also sustain LH suppression. While the use of progestins has been accepted in the follicular phase, with the advantages being oral use, reduced costs, and better acceptability, its use during the luteal phase has not yet been explored. Therefore, the hypothesis that progestin-induced LH suppression shall act similarly to antagonist even in the luteal phase has prompted us to compare oral progestins with the accepted antagonist-based LH suppression in the luteal phase of a DuoStim protocol. |