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CTRI Number  CTRI/2018/05/014207 [Registered on: 29/05/2018] Trial Registered Retrospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Do infertile women have a lower ovarian reserve than fertile women in the reproductive age group in India 
Scientific Title of Study   Comparison of ovarian reserve as measured by Anti Mullerian hormone and Antral Follicle Count between fertile and Infertile women in India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr NALINI MAHAJAN 
Designation  Director Mother and Child Hospital, Defence Colony,New Delhi 
Affiliation  MOTHER AND CHILD HOSPITAL, DEFENCE COLONY, NEW DELHI 
Address  MOTHER AND CHILD HOSPITAL, D 59 , DEFENCE COLONY, NEW DELHI.

South
DELHI
110024
India 
Phone  9810087666  
Fax    
Email  dr.nalinimahajan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr NALINI MAHAJAN 
Designation  Director Mother and Child Hospital, Defence Colony,New Delhi 
Affiliation  MOTHER AND CHILD HOSPITAL, DEFENCE COLONY, NEW DELHI 
Address  MOTHER AND CHILD HOSPITAL, D 59 , DEFENCE COLONY, NEW DELHI.

South
DELHI
110024
India 
Phone  9810087666  
Fax    
Email  dr.nalinimahajan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jasneet Kaur 
Designation  ASSOCIATE CONSULTANT 
Affiliation  MOTHER AND CHILD HOSPITAL, DEFENCE COLONY, NEW DELHI 
Address  MOTHER AND CHILD HOSPITAL, D 59 , DEFENCE COLONY, NEW DELHI.

South
DELHI
110024
India 
Phone  9728666342  
Fax    
Email  drjasneet19@gmail.com  
 
Source of Monetary or Material Support  
monetary support Mother and Child Hospital. Material support for AMH and Vit D tests Biomereuix 
 
Primary Sponsor  
Name  MOTHER AND CHILD HOSPITAL 
Address  D 59, DEFENCE COLONY, NEW DELHI-110024 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrNalini Mahajan  Mother and Child Hospital  D 59 Defence Colony. New Delhi 110024
South
DELHI 
9810087666

dr.nalinimahajan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indian Fertility Society IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  INFERTILITY AND REPRODUCTION ISSUES,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  39.00 Year(s)
Gender  Female 
Details  infertile women and fertile women with at least one child 
 
ExclusionCriteria 
Details  Women with PCOS, unilateral oophorectomy, endometriosis grade 3&4,women taking vitamin D supplementation(in the fertile group) 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
comparison of Ovarian reserve between infertile and fertile women by AMH and AFC measurement.  once 
 
Secondary Outcome  
Outcome  TimePoints 
build AMH normogram in fertile population
and Vitamin D nomogram in fertile population 
once 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   01/06/2017 
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="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

AMH levels and AFC are considered the most sensitive and specific markers of ovarian reserve. They are used to predict response to ovarian stimulation by gonadotrophins during in-vitro fertilization. Ovarian reserve depletes with age though there is a great inter-individual variation in the rate of decrease. There is also an ongoing debate regarding the predictive ability of AMH and AFC for pregnancy and live birth outcome in IVF. AMH levels are often used to counsel infertile women on the need for early shift to IVF. Many researchers have brought to light the observation that AMH does not predict fecundity and that women with very low levels of AMH can conceive spontaneously. Ethnicity has been associated with altered age-specific levels of AMH. Women of Chinese, Black African, Hispanic and South Asian descent are reported to have a lower AMH at a given age compared with Caucasian women. Iglesias et al reported a  6-year age difference in ovarian reserve markers and ovarian response between Spanish and Indian women in favor of the Spanish, suggesting ethnic differences in ovarian aging. Whether this ethnic disparity reflects accelerated ovarian ageing or inherent genetic differences is unclear. A recent study by Hvidman et al 2016 looking at the same issue in Caucasian women found that the available number of growing antral follicles and their capability to produce AMH in the early follicular phase is the same in infertile patients and controls.Nutritional factors have been implicated to affect the ovarian reserve. There are conflicting data in literature  regarding the association  of Vitamin D  levels with the ovarian reserve markers .

Our study may elicit differences in ovarian reserve between fertile and infertile population in India and would help us to prepare age specific nomograms for AMH in both the fertile and infertile population .Our results may help clinicians to counsel infertile women when discussing assisted reproductive technology.

We would also like to assess the vitamin D levels in the fertile population and prepare nomograms for the same as it would help us in having an in depth understanding of the association of vitamin D with ovarian reserve markers.  
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