| CTRI Number |
CTRI/2026/03/105219 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness and Safety of Oral Progesterone Tablet NMP SR 400 mg for Hormonal Support After Egg Collection in Women Undergoing IVF with Freeze-All Strategy |
|
Scientific Title of Study
|
A Single Arm Observational Study Evaluating NMP SR Oral Tablets for Luteal Phase Support and Pregnancy Outcomes in IVF Cycles Using GnRH Agonist Trigger and Freeze All Strategy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CIEC/2026/0049 |
DCGI |
|
|
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 |
09168898823 |
| 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
MAHARASHTRA
411019
India |
| Phone |
09168898823 |
| 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
MAHARASHTRA
411019
India |
| Phone |
09168898823 |
| 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 |
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 Mumbai Pune Highway Chinchwad Pune 411019 Maharashtra India
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18 to 38 years
Undergoing IVF or ICSI with GnRH agonist trigger
Freeze all cycle strategy
AMH more than equal to 1.2 ng per mL
No allergy to progesterone
Written informed consent obtained |
|
| ExclusionCriteria |
| Details |
Uncorrected uterine or endometrial abnormality
Medications affecting progesterone metabolism
Severe hepatic impairment
Concurrent interventional trial participation
Planned use of another progesterone formulation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants achieving serum progesterone within target range of 7 to 20 ng per mL |
Days 5 8 11 and 14 post oocyte retrieval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Endometrial thickness in mm |
Day 8 post oocyte retrieval |
| Trilaminar endometrial morphology |
Day 11 post oocyte retrieval |
| Clinical Pregnancy Rate |
6 weeks gestation confirmed by Ultrasound |
| Ongoing pregnancy rate |
20 Weeks gestation |
| Live Birth Rate |
At delivery |
| Incidence & nature of Adverse events |
From initiation of NMP SR until Day 14 post oocyte retrieval |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
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="6"
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
|
In IVF with GnRH agonist trigger early luteal phase deficiency requires exogenous progesterone NMP SR 400 mg Natural Micronized Progesterone Sustained Release is an oral formulation offering consistent progesterone release Objective To assess effectiveness and safety of NMP SR 400 mg once daily as luteal phase support Methods Prospective single arm observational study in women 18 to 38 years IVF with agonist trigger freeze all strategy Serum progesterone on Days 5 8 11 14 post OPU endometrial TVS on Days 8 and 11 Pregnancy outcomes followed to delivery Primary Outcome Proportion achieving serum P4 7 to 20 ng per mL Secondary endometrial parameters clinical ongoing pregnancy rates live birth rate adverse events N equals 50 Nirmiti Clinic Pune |