| CTRI Number |
CTRI/2019/12/022208 [Registered on: 02/12/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Age related distribution of ovarian reserve marker in Indian infertile women |
|
Scientific Title of Study
|
Age related trends of serum Anti-Mullerain Hormone (AMH) and Antral Follicular Count (AFC) in Indian Infertile Women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NISHANTHINI SENGEETHA K S |
| Designation |
MBBS. MS OBG. DMAS. FELLOW IN REPRODUCTIVE MEDICINE |
| Affiliation |
Gunasheela Surgical and Maternity Hospital |
| Address |
Department of Reproductive Medicine,
No.1, Dewan N. Madhava Rao Road, Basavanagudi
Bangalore
KARNATAKA
560004
India |
| Phone |
8220466600 |
| Fax |
|
| Email |
nishasengee12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NISHANTHINI SENGEETHA K S |
| Designation |
MBBS. MS OBG. DMAS. FELLOW IN REPRODUCTIVE MEDICINE |
| Affiliation |
Gunasheela Surgical and Maternity Hospital |
| Address |
Department of Reproductive Medicine
No.1, Dewan N. Madhava Rao Road, Basavanagudi,
Bangalore
KARNATAKA
560004
India |
| Phone |
8220466600 |
| Fax |
|
| Email |
nishasengee12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NISHANTHINI SENGEETHA K S |
| Designation |
MBBS. MS OBG. DMAS. FELLOW IN REPRODUCTIVE MEDICINE |
| Affiliation |
Gunasheela Surgical and Maternity Hospital |
| Address |
Department of Reproductive Medicine,
No.1, Dewan N. Madhava Rao Road, Basavanagudi
Bangalore
KARNATAKA
560004
India |
| Phone |
8220466600 |
| Fax |
|
| Email |
nishasengee12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gunasheela Surgical and Maternity Hospital, Bangalore 560 004 |
|
|
Primary Sponsor
|
| Name |
Gunasheela Surgical and Maternity Hospital |
| Address |
Madhava Rao Road, Basavanagudi, Bangalore 560 004 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 NISHANTHINI SENGEETHA K S |
Gunasheela Surgical and Maternity Hospital |
Department of Reproductive Medicine,
No.1, Dewan N. Madhava Rao Road, Basavanagudi
Bangalore
KARNATAKA |
8220466600
nishasengee12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gunasheela Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Female |
| Details |
1) Age between 20-44 years
2) BMI 18 to 30
3) Presence of both ovaries |
|
| ExclusionCriteria |
| Details |
1) Pituitary / Adrenal disorders
2) Malignancy
3) PCOS
4) Proven Tuberculosis
5) Smoking
6) History of chemotherapy or radiotherapy
7) Ovarian surgery in the past 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ovarian Reserve
|
Cross sectional study, only once sample will be collected from infertile women
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AMH and AFC |
Cross sectional study, only once sample will be collected from infertile women |
|
|
Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="5000"
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)
|
02/12/2019 |
| 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="3"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be published in suitable journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
SUMMARY The introduction of AMH and AFC in Reproductive Endocrinology is considered a revolution in the prediction of ovarian reserve for individualizing treatment and counsel the couple regarding successful treatment. AMH is produced by granulosa cells, so serum AMH levels gradually decreases with advancing age due to reduction of the number of antral follicles. Serum AMH measurements are less dependent on operators and do not have intra and inter cycle variation. AFC is also a good predictor of ovarian response. AFC has the closest association with chronological age in normal and infertile Indian women. Present study will provide relationship between age and AMH & AFC. |