| CTRI Number |
CTRI/2024/12/078124 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Oral natural micronized progesterone sustained release formulation as a support for luteal phase |
|
Scientific Title of Study
|
A Prospective observational study of oral natural micronized progesterone sustained release formulation as luteal phase support |
| 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 Sunita Chandra |
| Designation |
Director and chief consultant Gynaecologist |
| Affiliation |
Rajendra Nagar Hospital and IVF center |
| Address |
Rajendra Nagar Hospital and IVF center, 74 Rajendra Nagar, 2nd street, Near Navyug Radiance School, Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9415405091 |
| Fax |
|
| Email |
apgl2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Chandra |
| Designation |
Director and chief consultant Gynaecologist |
| Affiliation |
Rajendra Nagar Hospital and IVF center |
| Address |
Rajendra Nagar Hospital and IVF center, 74 Rajendra Nagar,2nd street, Near Navyug Radiance School, Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9415405091 |
| Fax |
|
| Email |
apgl2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Singh |
| Designation |
Fertility Advisor |
| Affiliation |
Rajendra Nagar Hospital and IVF center |
| Address |
Rajendra Nagar Hospital and IVF center, 74 Rajendra Nagar, 2nd street, Near Navyug Radiance School, Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9453763235 |
| Fax |
|
| Email |
pallavi.sunitaivf8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alembic Pharmaceuticals Ltd, Prime Corporate Park, 2nd Floor, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri- East, Mumbai-400099 |
|
|
Primary Sponsor
|
| Name |
Alembic Pharmaceuticals Ltd |
| Address |
2nd Floor, Prime Corporate Park, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri-east, Mumbai, Maharashtra- 400099 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sunita Chandra |
Rajendra Nagar Hospital and IVF Center |
74 Rajendra Nagar, 2nd Street, Near Navyug Radiance School, Lucknow
Lucknow
UTTAR PRADESH |
9415405091
apgl2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira IVF Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Woman ready to give informed consent for participation in study. |
|
| ExclusionCriteria |
| Details |
a. Women with history of Progesterone (Natural or synthetic) use in the last 3 months
b. History of tubal insufficiency or obstruction including Endometriosis or Polycystic
Ovarian Syndrome,
c. History of AST and, or ALT greater than 2.5 x ULN (active liver disease),
d. History of Serum creatinine greater than 1.5 mg per dl (active renal disease),
e. History of Uncontrolled hypertension, hypercholesterolemia or diabetes,
f. History of Psychoactive disease or on antidepressants,
g. History of Smoking
h. History of Myocardial infarction, stroke, cardiovascular or circulatory or clotting
disorders
i. History of Oral anticoagulants or prolonged use of high doses of NSAIDs,
j. Hypersensitivity to Natural micronized progesterone
k. Any condition that, in the opinion of the investigator, does not justify the patient’s
inclusion in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum Progesterone(P)levels(ng/ml) |
Day 0 and Day 5 |
|
|
Secondary Outcome
|
|
|
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)
|
24/12/2024 |
| 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="0"
Months="2"
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
|
A prospective observational study of oral natural micronized progesterone sustained release formulation as luteal phase support to assess serum progesterone concentration on day 0 of intra-uterine insemination or following ovulation induction and day 5 in patients who received luteal phase support with oral micronized progesterone sustained release 400 mg tablet. |