| CTRI Number |
CTRI/2020/09/027760 [Registered on: 11/09/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the causes of irregular menses in young girls. |
|
Scientific Title of Study
|
Evaluation of Hormonal and Metabolic Parameters in Adolescent and Young Indian Girls with Menstrual dysfunction |
| Trial Acronym |
AYoMI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Kachhawa |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 3086 3rd floor Teaching Block Dept of Obs and Gynae AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868246702 |
| Fax |
911126588641 |
| Email |
garimakhadgawat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garima Kachhawa |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 3086 3rd floor Teaching Block Dept of Obs and Gynae AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868246702 |
| Fax |
911126588641 |
| Email |
garimakhadgawat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nutan |
| Designation |
Junior resident |
| Affiliation |
AIIMS |
| Address |
Room no. 27,hostel no. 19,masjid moth,AIIMS
New Delhi
DELHI
110029
India |
| Phone |
7982123119 |
| Fax |
911126588641 |
| Email |
nnutan709@gmail.com |
|
|
Source of Monetary or Material Support
|
| No funds required as it is an Institute based PG thesis protocol |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
NEW DELHI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Garima Kachhawa |
All India Institute of Medical Sciences |
Department of Obstetrics and Gynaecology, 3rd Floor Teaching Block
New Delhi
DELHI |
9868246702
911126588641
garimakhadgawat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, (2) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Female |
| Details |
Adolescents and young girls in the age group of 14 -21 years with menstrual irregularities. |
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Any chronic medical or surgical illness.
3.Taking or history of taking any hormonal treatment over the past 3 months.
4.Taking or history of taking glucocorticoids,lipid lowering drugs,glucose lowering drugs or anti obesity drugs within 3 months of study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the clinical and hormonal characteristics of young adolescents girls with menstrual irregularity.
1.Clinical-BMI,WHR,Modified FG score.
2.Hormonal-Serum FSH,LH,AMH,Testosterone |
Day 2 LH,FSH,S.testosterone,AMH at the time of recruitement.
BMI at the time of recruitement. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To correlate menstrual irregularity with metabolic parameters1(SHBG,Lipid profile,GTT)
2. To correlate s. AMH with BMI in adolescents with menstrual irregularities.
3.To correalte hyperandrogenemia with BMI in adolescents with menstrual irregularities.
4.To evaluate the ovarian volume. |
Day 2 LH,FSH,S.testosterone,AMH at the time of recruitement.
BMI at the time of recruitement. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/09/2020 |
| 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="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Many young girls complain of irregular mentrual cycles,though the problems often are unreported.The exact cause of irregular menses in adolescent and young girls is not clearly established as in many girls this may be part of development. The objective of this study is to correlate the menstrual irregularities with factors of glucose and fat metabolism and hormonal parameters. The participants will be in the age group of 14-21 years presenting with menstrual irregularity. .The participants will be evaluated by detailed history taking ,physical examination anthropometric prameters, hirsutism by Ferriman Gallwey score and acne by global acne grading system. Blood samples will be taken for hormonal and metabolic parameters. No intervention will be done.The main outcome will be seen as correlation of menstrual irregularities with BMI and metabolic parameters,hyperandogenemia with serum AMH levels. |