A prospective study to evaluate safety and efficacy of Egrich tablets on oocyte quality in women undergoing invitro fertilization (IVF)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Improvement in oocyte quality, measured by the number of competent metaphase II (MII) oocytes retrieved after IVF.
研究概览
简要总结
•INFERTILITY IS A WIDESPREAD CONCERN AFFECTING APPROXIMATELY 10-15% OF COUPLES WORLDWIDE, DEFINED AS THE INABILITY TO CONCEIVE AFTER ONE YEAR OF UNPROTECTED INTERCOURSE.
•FEMALE INFERTILITY IS RESPONSIBLE FOR 30-40% OF INFERTILITY CASES.
•POOR-QUALITY OOCYTES OFTEN LEAD TO FAILED FERTILIZATION, EARLY EMBRYONIC ARREST, CHROMOSOMAL ANOMALIES, AND MISCARRIAGE.
•FOR SUCCESSFUL PREGNANCY, AN OOCYTE MUST HAVE THE CAPACITY TO UNDERGO FERTILIZATION, INITIATE EMBRYONIC DIVISION, AND SUSTAIN HEALTHY DEVELOPMENT TO THE BLASTOCYST STAGE.
EGRICH CONTAINS COENZYME Q10 -150 MG, DEHYDROEPIANDROSTERONE (DHEA) 40 MG, GAMMA TOCOTRIENOL 12.5 MG, ZINC SULPHATE 12.5 MG POLICOSANOL -10 MG, L-TRYPTOPHAN-1.5 MG, CHOLECALCIFEROL- 600 IU. ALL OF THESE COMPONENTS IMPROVE THE OOCYTE QUALITY AND ALSO REDUCES OXIATIVE STRESS WITHIN THE OCCYTES.
INJ GCSF IS GRANULOCYTE COLONY STIMULATING FACTOR, WHICH IMPROVES OVARIAN PREANTRAL FOLLICLES AND ALSO ANTI-MULLERIAN HORMONE IN PATIENTS WITH DIMINISHED OVARIAN RESERVE . IT ALSO IMPROVED EMBRYONIC IMPROVEMENT AND PREGNANCY RATE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Presence of factors indicating compromised oocyte quality (advanced maternal age or previous IVF failures).
- •Subjects with prior history of poor oocyte quality in terms of maturity on retrieval.
- •Subjects who couldn’t meet the benchmark blastocyst conversion rate Female subjects who are willing to commit the study restrictions.
排除标准
- •Subjects with endometriosis involving uterus, ovaries, bladder, fallopian tubes, pelvis or deeply infiltrating endometriosis.
- •Subjects with diagnosis of HIV, HCV, HBV, VDRL and other sexually transmitted diseases.
- •Known allergy or hypersensitivity to any components of Egrich tablets.
- •History of significant medical conditions affecting fertility or pregnancy outcome.
- •Use of medications known to impact fertility or oocyte quality within the past three months.
- •Male factor such as SOAT (total count less than 1 million per ml).
结局指标
主要结局
Improvement in oocyte quality, measured by the number of competent metaphase II (MII) oocytes retrieved after IVF.
时间窗: Three months
次要结局
- Fertilization rate.(Embryo quality (morphological scoring of embryos).)
研究者
Abinaya Durasisingam
Department of Reproductive medicine and Endocrinology