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临床试验/CTRI/2025/09/094008
CTRI/2025/09/094008尚未招募不适用

Association of Serum Folic Acid and Vitamin B12 levels with Follicle to Oocyte Index and Embryo Quality in Women undergoing IVF/ ICSI

VMMC and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Serum vitamin B12 levels.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Women between ages of 21-40, with inability to conceive for atleast 1 year, planned for IVF or ICSI treatment.

排除标准

  • Women presenting with infertility with uncontrolled chronic illness: Tuberculosis Diabetes Hypertension Malignancy.

结局指标

主要结局

Serum vitamin B12 levels.

时间窗: Baseline, 2 weeks and 3 weeks.

Serum folic acid levels.

时间窗: Baseline, 2 weeks and 3 weeks.

Number of oocytes retrieved.

时间窗: Baseline, 2 weeks and 3 weeks.

Follicle to oocyte index (FOI).

时间窗: Baseline, 2 weeks and 3 weeks.

Day 3 Embryos graded for quality according to ESHRE, European Society of Human Reproduction and Embryology grading system.

时间窗: Baseline, 2 weeks and 3 weeks.

Association of serum Folic acid and Vitamin B12 levels with follicle to oocyte index and Embryo quality.

时间窗: Baseline, 2 weeks and 3 weeks.

次要结局

未报告次要终点

研究者

发起方
VMMC and Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shruti Choudhary

VMMC and Safdarjung Hospital

研究点 (1)

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