The Effect of Ovamax on Oocyte Quality in Women Undergoing IVF
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Mean oocyte score
研究概览
简要总结
Oocyte quality is a basic parameter that affects embryo quality and therefore it influences the outcome of assisted reproduction. It has been suggested that oocyte quality is improved by the intake of vitamins and antioxidants.
Ova-Max is a dietary supplement that consists of vitamins, minerals and antioxidants which improve women's oocytes by preventing oxidative stress. Specifically, Ovamax includes Chasteberry, Melatonin, Myo-Inositol, Folic Acid, Co-Enzyme Q10, Vitamin E, L-Arginine, Grape seed extract and Alpha-lipoic Acid. The purpose of this study is to evaluate the influence of Ova-max intake on oocyte quality in women undergoing In Vitro Fertilization.
According to the research hypothesis the administration of Ova-Max for three months increases oocyte quality in women undergoing intracellular sperm injection after ovarian stimulation and oocyte retrieval.
详细描述
Randomisation
This study is a blind randomized control trial to evaluate the association between Ova-Max intake and the quality of oocytes retrieved after ovarian stimulation. Randomization will be performed at least three months prior to initiation of treatment and patients will be assigned to either Ova-max or placebo by a computer-generated randomization list.
Ovarian Stimulation
A standard ovarian stimulation protocol for all patients will be followed with 200-300 IU of recombinant FSH and GnRH antagonist starting on day 5 of stimulation.
Induction of final oocyte maturation will be performed by recombinant hCG or GnRH agonist. Women who are planned for fresh embryo transfer, will be administered subcutaneous progesterone for luteal phase support starting on the day of oocyte retrieval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
use of placebo, masked randomisation list
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients less than 46 years of age
- •ICSI for fertilisation to allow evaluation of oocyte quality
- •Exclusion criteria:
- •Women with endometriosis
- •Women with only one ovary
- •More than two previous IVF cycles
- •Use of testicular sperm
- •Intake of other dietary supplements
- •Poor responders
排除标准
- 未提供
结局指标
主要结局
Mean oocyte score
时间窗: 1-3 hours after oocyte retrieval
The sum of the total oocyte scores of the patient divided by the number of her oocytes. Oocytes is assessed according to the following parameters: 1. Oocyte shape 2. Oocyte size 3. Ooplasm characteristics 4. Structure of the perivitelline space (PVS) 5. Zona pellucida (ZP) and 6. Polar body (PB) morphology Each parameter is graded as worst (-1), average (0), or best (1) and a total oocyte score (TOS) is calculated by summing up individual parameter assessments. The maximal TOS of an oocyte, therefore, could be +6, the lowest -6.
次要结局
- Percentage of mature oocytes(2-4 hours after oocyte retrieval)
- Percentage of fertilised oocytes(16-18 hours after fertilisation)
- Blastulation rate(day 5 after fertilisation)
- Pregnancy rate(6 weeks after embryo transfer)
- Total number of COCs collected(immediately after oocyte retrieval)
研究者
E.M. Kolibianakis
Professor of Obstetrics Gynaecology and Assisted Reproduction
Aristotle University Of Thessaloniki