| CTRI Number |
CTRI/2025/09/094008 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of Folic Acid and Vitamin B12 Levels with Egg and Embryo Quality in IVF |
|
Scientific Title of Study
|
Association of Serum Folic Acid and Vitamin B12 levels with Follicle to Oocyte Index and Embryo Quality in Women undergoing IVF/ ICSI |
| 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 Shruti Choudhary |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Dept of Obstetrics and Gynaecology,
VMMC and Safdarjung Hospital,
New Delhi
South
DELHI
110029
India |
| Phone |
7701875535 |
| Fax |
|
| Email |
shruti1choudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garima Kapoor |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Dept of Obstetrics and Gynaecology,
VMMC and Safdarjung Hospital,
New Delhi
South
DELHI
110029
India |
| Phone |
9810504509 |
| Fax |
|
| Email |
garimak79@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Choudhary |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Dept of Obstetrics and Gynaecology,
VMMC and Safdarjung Hospital,
New Delhi
South
DELHI
110029
India |
| Phone |
7701875535 |
| Fax |
|
| Email |
shruti1choudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital, New Delhi- 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital, New Delhi- 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Shruti Choudhary |
VMMC and Safdarjung Hospital |
IVF Centre, Dept of Obstetrics and Gynaecology, and Dept of Hematology,
VMMC and Safdarjung Hospital,
New Delhi- 110029
South
DELHI |
7701875535
shruti1choudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women between ages of 21-40, with inability to conceive for atleast 1 year, planned for IVF or ICSI treatment. |
|
| ExclusionCriteria |
| Details |
Women presenting with infertility with uncontrolled chronic illness:
Tuberculosis
Diabetes
Hypertension
Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Serum folic acid levels.
Serum vitamin B12 levels.
Number of oocytes retrieved.
Follicle to oocyte index (FOI).
Day 3 Embryos graded for quality according to ESHRE, European Society of Human Reproduction and Embryology grading system.
Association of serum Folic acid and Vitamin B12 levels with follicle to oocyte index and Embryo quality. |
Baseline, 2 weeks and 3 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
15/09/2025 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This prospective cohort study aims to evaluate the association between serum folic acid and vitamin B12 levels with the follicle-to-oocyte index (FOI) and embryo quality in women undergoing IVF/ICSI. Conducted at VMMC & Safdarjung Hospital, New Delhi, over 18 months with 50 participants, the study involves dietary assessment, serum folic acid and vitamin B12 levels analysis, controlled ovarian stimulation, oocyte retrieval, and Day 3 embryo grading using ESHRE criteria. Given the limited literature on this topic, the study also explores correlations between dietary intake and serum levels of these micronutrients, aiming to identify potential modifiable factors that influence oocyte yield and embryo development in IVF/ICSI. If an association is found, supplementation with folic acid and vitamin B12 prior to IVF/ICSI may improve embryo quality and outcomes. |