| CTRI Number |
CTRI/2026/02/102754 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“A study to compare two different hormone treatment methods used for ovarian stimulation and their outcomes in subfertile women undergoing frozen embryo transfer. |
|
Scientific Title of Study
|
Comparison of Assisted Reproductive Technology Outcomes in Progestin
Primed Ovarian Stimulation Versus Gonadotropin Releasing Hormone Antagonist
Protocol in Sub fertile Women in Frozen Embryo Transfer Cycle: An Open Label
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 |
Dr Milan Dhariwal |
| Designation |
M..Ch. resident |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences |
| Address |
Room-1, Department of Reproductive Medicine, Seikhpura
Patna
BIHAR
800014
India |
| Phone |
9153627959 |
| Fax |
|
| Email |
milan.dhariwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kalpana Singh |
| Designation |
HOD |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences |
| Address |
Room - 6, Department of Reproductive Medicine
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
drkalpana1@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milan Dhariwal |
| Designation |
M..Ch. resident |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences |
| Address |
Room-1, Department of Reproductive Medicine
Patna
BIHAR
800014
India |
| Phone |
9153627959 |
| Fax |
|
| Email |
milan.dhariwal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Reproductive Medicine |
| Address |
Room 1, Seikhpura , Patna, Bihar, India - 800014 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Milan Dhariwal |
Indira Gandhi Institute of Medical Sciences |
Room-1,Department of Reproductive Medicine Seikhpura , Patna - 800014
Patna
BIHAR |
9153627959
milan.dhariwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, IGIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N970||Female infertility associated withanovulation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj. Cetrorelix 0.25 mg |
Patients in this group will
receive a fixed GnRH antagonist protocol. Ovarian stimulation will begin on
day 2 or 3 of the menstrual cycle after transvaginal ultrasound with a
gonadotropin dose determined by baseline characteristics(age, BMI, AFC,
AMH). Follicular growth will be monitored by transvaginal ultrasound from
Day 6 of COS, and a GnRH antagonist (i.e.., cetrorelix) at a dose of 0.25 mg
SC daily will be initiated on Day 6 of COS and will continue until the trigger
day. The final oocyte trigger will be given when at least 3 follicles of 17mm
or more are observed on transvaginal ultrasound , GnRH agonist ( Decapeptyl)
and /or hCG injection will be used to trigger final oocyte maturation and
oocyte pickup will be performed after 35 hours following the trigger.
Duration - 18 months |
| Intervention |
Tab.Medroxyprogesterone acetate 10 mg |
Patients in this group will receive a
PPOS protocol. Ovarian stimulation will begin on day 2 or 3 of the menstrual
cycle after transvaginal ultrasound with a gonadotropin dose determined by
baseline characteristics. (age, BMI, AFC, AMH) Concurrently, an oral
progestin (i.e. medroxyprogesterone acetate) 10 mg 1 tablet daily at 10am will
be administered daily to suppress the premature LH surge till the day of
trigger. Follicular growth will be monitored by transvaginal ultrasound from
Day 6 of COS. The final oocyte trigger will be given when at least 3 follicles
of 17mm or more are observed on transvaginal ultrasound , GnRH agonist (
Decapeptyl) and /or hCG injection will be used to trigger final oocyte
maturation and oocyte pickup will be performed after 35 hours following the
trigger.
Duration - 18 months |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
Sub fertile women aged 21 to 38 years who are willing to participate in the
study and willing for freeze all strategy. |
|
| ExclusionCriteria |
| Details |
1. Grade 3 or higher endometriosis
2. Recurrent miscarriage with 2 or
more spontaneous abortion
3. Uterine structure abnormality |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of oocytes retrieved, number of mature oocytes
and number of D3/D5 embryo. |
At the end of 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It included duration & dosage of gonadotropins
used, incidence of premature LH surge, oocyte maturity rate, clinical pregnancy &
miscarriage rate. |
At the end of 18 months |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
02/03/2026 |
| 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="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
|
The aim is study the assisted reproductive technology outcomes in Progestin primed ovarian stimulation versus GnRH antagonist protocol in sub fertile women in frozen embryo transfer cycle.Many studies employ retrospective designs, which inherently limit causal inference and increase susceptibility to selection bias and confounding. This methodological constraint reduces the internal validity and generalizability of findings. Several investigations have small sample sizes, limiting statistical power and increasing the risk of Type II errors. This affects the reliability of conclusions and restricts the external validity of the results. A paucity of well-powered randomized controlled trials (RCTs) limits the strength of evidence, with many studies relying on observational or cohort designs, which compromises the ability to establish definitive efficacy and safety profiles. Your research aims to bridge these gaps by providing robust, generalizable evidence from an Indian population that will inform clinical practice and help standardize the optimal ovarian stimulation protocol for subfertile women in the region who are undergoing FET cycles. It is a single-center, prospective, open label randomized controlled trial. |