| CTRI Number |
CTRI/2026/03/105423 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing an Oral Tablet (Elagolix) and an Injectable Hormone Blocker to Prevent Early Hormone Rise in Women Undergoing IVF Treatment. |
|
Scientific Title of Study
|
Oral Elagolix versus Injectable GnRH Antagonist in IVF Freeze-All Cycles: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CIEC/2026/0048 |
DCGI |
| ELAG-IVF-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kundan V Ingale |
| Designation |
Principal Investigator and IVF Specialist |
| Affiliation |
Nirmiti Clinic |
| Address |
Q 224 226 IInd Floor Mayur Trade Centre Mumbai Pune Highway Chinchwad Pune 411019 Maharashtra India
Pune
MAHARASHTRA
411019
India |
| Phone |
9168898823 |
| Fax |
|
| Email |
drkingale@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kundan V Ingale |
| Designation |
Principal Investigator and IVF Specialist |
| Affiliation |
Nirmiti Clinic |
| Address |
Q 224 226 IInd Floor Mayur Trade Centre Mumbai Pune Highway Chinchwad Pune 411019 Maharashtra India
Pune
MAHARASHTRA
411019
India |
| Phone |
9168898823 |
| Fax |
|
| Email |
drkingale@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kundan V Ingale |
| Designation |
Principal Investigator and IVF Specialist |
| Affiliation |
Nirmiti Clinic |
| Address |
Q 224 226 IInd Floor Mayur Trade Centre Mumbai Pune Highway Chinchwad Pune 411019 Maharashtra India
Pune
MAHARASHTRA
411019
India |
| Phone |
9168898823 |
| Fax |
|
| Email |
drkingale@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Nirmiti Clinic Q 224 226 IInd Floor Mayur Trade Centre Chinchwad Pune 411019 |
|
|
Primary Sponsor
|
| Name |
Dr Kundan V Ingale |
| Address |
Nirmiti Clinic Q 224 226 IInd Floor Mayur Trade Centre Chinchwad Pune 411019 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kundan V Ingale |
Nirmiti Clinic |
Q 224 226 IInd Floor Mayur Trade Centre Chinchwad Pune 411019
Pune
MAHARASHTRA |
9168898823
drkingale@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
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 |
Cetrorelix 0.25 mg OR Ganirelix 0.25 mg |
0.25 mg Subcutaneous injection once daily |
| Intervention |
Elagolix |
150 mg twice daily (BID) at 12-hour intervals |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 21 to 38 years undergoing their first IVF cycle
Normal ovarian reserve AMH more than equal to 1 ng per mL and AFC more than equal to 8
BMI 18 to 30 kg per m²
No previous ovarian surgery
Signed written informed consent prior to any study specific procedure
|
|
| ExclusionCriteria |
| Details |
History of poor ovarian response less than equal to 3 oocytes retrieved in any prior stimulation
Known contraindications to GnRH antagonists
Known hypersensitivity to Elagolix or any of its excipients
Significant hepatic or renal impairment defined as alanine aminotransferase or aspartate aminotransferase more than two times the upper limit of normal, or estimated glomerular filtration rate less than sixty milliliters per minute per one point seven three square meters
Concurrent use of medications known to affect bone metabolism example bisphosphonates corticosteroids denosumab
Donor oocyte recipients excluded to maintain homogeneity of study population
Participation in another clinical trial within 30 days prior to enrollment
Positive infectious disease screening HBsAg Anti HCV HIV 1 and 2 VDRL |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of premature LH surge or progesterone rise on trigger day defined as
LH more than 10 IU per L on trigger day OR
Progesterone more than 1.5 ng per mL on trigger day |
8-14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total number of oocytes retrieved |
At oocyte retrieval approximately 34 to 36 hours after trigger administration |
| Mature oocyte rate MII oocytes divided by total oocytes retrieved |
Assessed at oocyte retrieval approximately 34 to 36 hours after trigger |
| Fertilization rate 2PN divided by inseminated oocytes |
Assessed on Day 1 after oocyte retrieval during fertilization assessment |
| Blastocyst formation rate total blastocysts divided by fertilized oocytes |
Assessed on Day 5 to Day 6 after oocyte retrieval during embryo culture |
| High quality blastocyst rate blastocysts graded greater than or equal to 3BB according to Gardner classification divided by total oocytes retrieved |
Assessed on Day 5 to Day 6 after oocyte retrieval |
| Clinical pregnancy rate defined as intrauterine gestational sac with cardiac activity |
Assessed at 6 to 7 weeks of gestation following embryo transfer |
| Ongoing pregnancy rate |
Assessed at 12 weeks gestation following embryo transfer |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/03/2026 |
| 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 Yet Recruiting |
| 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 prospective randomized open label parallel group non inferiority trial evaluates the efficacy and tolerability of oral Elagolix 150 mg twice daily compared with injectable GnRH antagonists Cetrorelix 0.25 mg or ganirelix 0.25 mg daily for prevention of premature LH surge during controlled ovarian stimulation in IVF freeze all cycles A total of 150 women aged 21 to 38 years undergoing their first IVF cycle with normal ovarian reserve will be randomized in a 1 to 1 ratio The primary endpoint is the incidence of premature LH surge or progesterone rise on trigger day Secondary outcomes include oocyte yield fertilization rate blastocyst formation clinical and ongoing pregnancy rates safety outcomes including OHSS and patient reported treatment satisfaction The study aims to determine whether oral Elagolix is non inferior to injectable GnRH antagonists while improving patient convenience and tolerability |