| CTRI Number |
CTRI/2026/01/100428 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Administration of GnRH antagonist in PCOS patients undergoing IVF. |
|
Scientific Title of Study
|
Antagonist administration from day 1 of IVF versus standard flexible day 5/6 antagonist administration in PCOS patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GDIFR/IEC/2025/11/M1-005 (Version-01; Date-17.11.2025) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Biswanath Ghosh Dastidar |
| Designation |
Research Director, IVF-ART, GDIFR |
| Affiliation |
Ghosh Dastidar Institute For Fertility Research Pvt Ltd |
| Address |
36 A/1, S.P. Mukherjee Road, Kolkata
Kolkata
WEST BENGAL
700025
India |
| Phone |
9830863894 |
| Fax |
|
| Email |
biswanath@gdifr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Biswanath Ghosh Dastidar |
| Designation |
Research Director, IVF-ART, GDIFR |
| Affiliation |
Ghosh Dastidar Institute For Fertility Research Pvt Ltd |
| Address |
36 A/1, S.P. Mukherjee Road, Kolkata
Kolkata
WEST BENGAL
700025
India |
| Phone |
9830863894 |
| Fax |
|
| Email |
biswanath@gdifr.in |
|
Details of Contact Person
Public Query
|
| Name |
Biswanath Ghosh Dastidar |
| Designation |
Research Director, IVF-ART, GDIFR |
| Affiliation |
Ghosh Dastidar Institute For Fertility Research Pvt Ltd |
| Address |
36 A/1, S.P. Mukherjee Road, Kolkata
Kolkata
WEST BENGAL
700025
India |
| Phone |
9830863894 |
| Fax |
|
| Email |
biswanath@gdifr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SELF (Ghosh Dastidar Institute For Fertility Research Pvt Ltd) |
| Address |
36 A/1, S.P. Mukherjee Road, Kolkata-700025 |
| Type of Sponsor |
Other [Clinic] |
|
|
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 |
| SUDARSAN GHOSH DASTIDAR |
Ghosh Dastidar Institute For Fertility Research Pvt Ltd |
36A/1 S P MUKHERJEE ROAD, KOLKATA -700025
GDIFR, ART laboratory, Div- Reproductive endocrinology and infertility
Dept- IVF-ART
Kolkata
WEST BENGAL |
9830031950
sudarsan.ivf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GDIFR IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified, fixed GnRH antagonist injection administration from day 1 of IVF stimulation |
Modified, fixed GnRH antagonist (cetrorelix acetate) injection administration from day 1 of IVF stimulation. This is hypothesized to be of dual benefit- to correct the deranged LH dominant endocrinologic milieu in the early follicular phase, and then prevent premature luteinization in the mid-late follicular phase |
| Intervention |
Standard, flexible GnRH antagonist injection administration from day 5 or 6 of IVF stimulation |
Standard GnRH antagonist (cetrorelix acetate) injection administration from day 5 or 6 of IVF stimulation based on monitoring of follicular sizes by ultrasound as well as by monitoring serum estradiol levels, as per established practise, to prevent premature luteinization |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
PCOS patients undergoing IVF |
|
| ExclusionCriteria |
| Details |
Patients with grade III-IV endometriosis, concurrent severe male factor infertility, or history of previous ovarian surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of clinical pregnancy rate between the two groups with Antagonist administration from day 1 of IVF versus standard flexible day 5/6. |
1. Recruitment of participants and randomisation- 0-6 months
2. Conduct and completion of study: 6-12 months
3. Data organisation and curation: 12-18 months
4. Data analysis and publication:12-18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare number of oocytes, proportion of fertilized oocytes, and proportion of top quality embryos achieved between 2 groups |
1. Recruitment of participants and randomisation- 0-6 months
2. Conduct and completion of study: 6-12 months
3. Data organisation and curation: 12-18 months
4. Data analysis and publication:12-18 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/01/2026 |
| 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="3"
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 - NO
|
|
Brief Summary
|
GnRH Antagonist protocols are now accepted as the preferred choice for IVF in PCOS patients as, compared to GnRH agonist protocols, they have been shown to offer the distinct advantage of lower incidence of OHSS, while simultaneously offering comparable pregnancy rates. This is of further benefit as antagonist protocol may be combined with agonist trigger and delayed frozen embryo transfer, further lowering risk of OHSS. Standard antagonist protocol involves antagonist administration from day 5 or day 6 to prevent premature luteinization. However, studies have shown that deranged endocrinologic profile in PCOS patients- specifically, elevated serum LH levels at the start of the cycle- may negatively impact IVF outcome due to impaired follicular development and egg quality. We recently published our retrospective data showing significantly improved outcomes in PCOS patients when antagonist is administered from day 1 of stimulation, compared to flexible antagonist administration from day 5 or day 6. |