| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
INFERTILITY AND REPRODUCTION ISSUES, |
|
|
Intervention / Comparator Agent
|
|
|
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) |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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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. |