| CTRI Number |
CTRI/2026/03/105106 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Single dose trigger versus repeat dose trigger] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ART Outcomes in Repeat Gonadotrophin-releasing Hormone Agonist Trigger Versus Single Dose Agonist Trigger in PCOS Patients Undergoing IVF/ICSI |
|
Scientific Title of Study
|
Comparison of ART Outcomes in Repeat Gonadotrophin-releasing Hormone Agonist Trigger Versus Single Dose Agonist Trigger in PCOS Patients Undergoing IVF/ICSI:A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jhalak Jain |
| Designation |
Mch resident |
| Affiliation |
Indira Gandhi Institute of medical sciences |
| Address |
Room 1 Department of reproductive medicine Indira Gandhi Institute of medical Sciences Patna-800014
Patna
BIHAR
800014
India |
| Phone |
8447022568 |
| Fax |
|
| Email |
jhalakjn96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kalpana Singh |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of medical sciences |
| Address |
Department of reproductive medicine,Indira Gandhi Institute of medical sciences,Patna
Patna
BIHAR
800014
India |
| Phone |
8447022568 |
| Fax |
|
| Email |
jhalakjn96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jhalak Jain |
| Designation |
Mch resident |
| Affiliation |
Indira Gandhi Institute of medical sciences |
| Address |
Room 1,Department of reproductive medicine, Indira Gandhi Institute of medical sciences, Patna
Patna
BIHAR
800014
India |
| Phone |
8447022568 |
| Fax |
|
| Email |
jhalakjn96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of medical sciences Department of reproductive medicine Patna,Bihar |
|
|
Primary Sponsor
|
| Name |
Jhalak Jain |
| Address |
Indira Gandhi Institute of Medical sciences, Bailey road , Sheikhpura, Patna-800014 |
| 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 |
| Jhalak Jain |
Indira Gandhi Institute of medical sciences |
Room 1,Department of reproductive medicine,Sheikhpura,Patna-800014
Patna
BIHAR |
8447022568
jhalakjn96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Repeat dose of GnRh agonist trigger |
A repeat-dose GnRH agonist trigger given in PCOS patients undergoing IVF cycles with GnRH antagonist protocol |
| Comparator Agent |
Single dose of GnRh agonist trigger |
Single dose of GnRh agonist trigger given in PCOS patients |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
All women between the age 21-38 years, satisfying diagnostic criteria of PCOS according to ESHRE(2018)criteria which defines: Any 2 of 3
1.Irregular menstrual cycles and anovulation
2.Clinical or biochemical signs of hyperandrogenism
3.Polycystic ovarian morphology
after excluding other disorders with similar clinical presentation
|
|
| ExclusionCriteria |
| Details |
Other causes of anovulation/irregular menses-Hypothyroid, Hyperprolactinemia, Premature Ovarian Insufficiency
Other causes of hyperandrogenemia like late onset Congenital Adrenal Hyperplasia, Cushing’s Syndrome. |
|
|
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 |
| total oocytes retrieved and no. of mature oocytes retrieved |
48 hours After ovum pickup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hormonal parameters (LH) at 12 hours post first trigger, oocyte maturity rate , number of top-quality embryos (day 3) & blastocysts (day 5), incidence of OHSS (if any) , clinical pregnancy rates following frozen embryo transfer |
Till 4weeks post 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
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/03/2026 |
| 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
|
All patients , registered in the Department of reproductive medicine, fulfilling inclusion and exclusion criteria undergoing IVF with antagonist protocol will be enrolled in this study after written consent and proper workup as per the protocol of the department. A written informed consent will be obtained from patients enrolled in the study. Baseline transvaginal ultrasound will be done(on Mindray DC80 machine frequency of transvaginal probe 7-9MHz) on day2/day3 of cycle. Controlled ovarian stimulation with gonadotropins is started from day2 or day3 of cycle. Dose of gonadotropins will depend on age of the patient, antral follicular count, AMH,BMI GnRH antagonist fixed protocol would be followed ,i.e, GnRH antagonist is started on 6th day of stimulation with gonadotropins. RANDOMIZATION Computer-generated randomization sequence using permuted blocks of variable sizes (4, 6, 8) will be employed. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes (SNOSE). Randomization will occur on the day of recruitment. • Intervention: • Group A (Single-dose GnRH agonist trigger): • Triptorelin 0.2 mg subcutaneous injection administered 35 hours before scheduled oocyte retrieval • Group B (Repeat GnRH agonist trigger) • Gonadotropins and antagonist are continued until atleast 3 follicles attain a size of greater than equal to17mm following which inj.triptorelin 0.2mg will be administered for final oocyte maturation. Second dose of inj.triptorelin 0.1mg will be administered 12 hours after the first dose . • As per the protocol practised in the institute, 2 doses of NSAID 12 hours apart is given one day before ovum pickup. • Ovum pickup will be done 35 hours after the administration of trigger. • Outcomes would be studied with respect to number and quality of oocytes(M2 oocytes, cleavage stage and blastocyst stage embryos formed and clinical pregnancy rate.
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