| CTRI Number |
CTRI/2025/10/096009 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two hormonal trigger methods before egg collection to assess embryo quality in women with poor ovarian response undergoing IVF |
|
Scientific Title of Study
|
Double vs Dual Trigger in POSEIDON 3–4: A Multicenter RCT on Embryo quality in Poor Responders |
| 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 Parinaaz Parhar |
| Designation |
Regional Medical Head |
| Affiliation |
Oasis School of Human Embryology and Reproductive Medicine (OSHERM) |
| Address |
Oasis Fertility,
2nd Floor,
CVK Square,
SD Road,
Secunderabad
Plot No. 8-2-120/112/A/7, Road Number 9, Jubilee Hills, Hyderabad, Telangana 500034
Hyderabad
TELANGANA
500003
India |
| Phone |
9881474476 |
| Fax |
|
| Email |
parinaaz.parhar@oasisindia.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parinaaz Parhar |
| Designation |
Regional Medical Head |
| Affiliation |
OSHERM |
| Address |
Oasis Fertility,
2nd Floor,
CVK Square,
SD Road,
Secunderabad
Plot No. 8-2-120/112/A/7, Road Number 9, Jubilee Hills, Hyderabad, Telangana 500034
Hyderabad
TELANGANA
500003
India |
| Phone |
9881474476 |
| Fax |
|
| Email |
parinaaz.parhar@oasisindia.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parinaaz Parhar |
| Designation |
Regional Medical Head |
| Affiliation |
Oasis School of Human Embryology and Reproductive Medicine (OSHERM) |
| Address |
Oasis Fertility,
2nd Floor,
CVK Square,
SD Road,
Secunderabad
Plot No. 8-2-120/112/A/7, Road Number 9, Jubilee Hills, Hyderabad, Telangana 500034
Hyderabad
TELANGANA
500003
India |
| Phone |
9881474476 |
| Fax |
|
| Email |
parinaaz.parhar@oasisindia.in |
|
|
Source of Monetary or Material Support
|
|
Self funded by the institute, Oasis Fertility. Address: Oxford Street, Sarojini Devi Road, 2nd Floor CVK Park Square, Krishna Complex, Kalasiguda, Secunderabad-500003, Telangana, India. |
|
|
Primary Sponsor
|
| Name |
OSHERM, Oasis Fertility |
| Address |
Plot No. 8-2-120/112/A/7, Road Number 9, Jubilee Hills, Hyderabad, Telangana 500034 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parinaaz Parhar |
Oasis Fertility |
Oasis Fertility,
2nd Floor,
CVK Square,
SD Road,
Secunderabad
Hyderabad
TELANGANA |
9881474476
parinaaz.parhar@oasisindia.in |
| Dr Durga Rao |
Oasis Fertility, Banjara Hills |
No 8-2-269/3/1/4-2, Road, nearby NATCO Pharma, Park View Enclave, banjara Hills
Hyderabad
TELANGANA |
9491111011
durga@oasisindia.in |
| Dr Bhavishya Reddy |
Oasis Fertility, Miyapur |
R V Plaza, 4 th Floor, Plot No 203, Nearby Mythri Nagar, Arch, Hafeezpet, Madeenaguda
Hyderabad
TELANGANA |
7981134930
drkbhavishyareddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Oasis Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Infertile women of age 21 years to 42 years with diminished ovarian reserve. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator Arm (Dual Trigger):
|
Given once on day of trigger for oocyte maturation when at least 2-3 follicles are more than 17mm in size Combination of GnRH agonist + HCG at 35–36h before oocyte retrieval |
| Intervention |
Intervention Arm (Double Trigger):
|
Given once on day of trigger for oocyte maturation when at least 2-3 follicles are more than 17mm in size. GnRH agonist at 38–40h + HCG/rHCG at 35–36h were given before oocyte retrieval
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
Infertile women with low ovarian reserve as per POSEIDON criteria. |
|
| ExclusionCriteria |
| Details |
Severe systemic illness
Contraindication to GnRH agonist or HCG
Participation in another clinical trial |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oocyte retrieval rate
Number of mature oocytes retrieved
Fertilization rate
Blastulation rate
Number of top-quality embryos |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oocyte retrieval rate
Fertilization rate
Blastulation rate |
1 year |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
31/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [parinaaz.parhar@oasisindia.in].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized controlled study aims to compare the embryological outcomes with two trigger protocols for oocyte maturation- the dual trigger consisting of Inj hCG and Inj GnRH agonist given together at 35- 36 hours before oocyte retrieval vs double trigger- Inj GnRH agonist given 38-40 hours prior vs Inj hCG given 34- 35 hours before oocyte retrieval. The study will evaluate the difference in oocyte retrieval rate, maturity rate, fertilization rate, premature ovulation rate, blastulation rate and top quality embryo rate between the two groups. The patients would be further analysed under the subgroups based on the protocol used (PPOS vs GnRH antagonist) and the age of the patients studied (<35 years and >35 years old). Since there are no previous randomized controlled trials comparing outcomes using these two trigger strategies in this population of patients, this study aims to identify the optimal trigger strategy to maximize the oocyte maturity rate and embryological outcomes in poor responder patients. We aim to include 150 patients in this study over a period of 1 year. |