CTRI/2021/10/037448已完成3 期
A Prospective, Open Label, Multi-Center Study To Evaluate The Safety And Efficacy Of Supplementation With Mulmina Amla Orange Health Drink In IVF Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •i.Age 21-38 yrs
- •ii.BMI between 18-32 kg/m2
- •iii.Basal FSH,LH,E2,Progesterone P4 and Prolactin levels within normal range on menstrual day 2
- •iv.Women with Normal or insignificant haematology and blood biochemistry done during screening visit
- •v.TVUS documenting presence of both ovaries without evidence of abnormality such as endometrioma >5 cms ,presence of hydrosalpinx
- •vi.Husband or male partner or donor sperm with normal sperm motility and count ,or with Oligoasthenospermia
- •vii.Able to provide written informed consent for the study participation.
- •viii.If using fertility modifier supplements containing VitaminC,VitaminE,AminoAcid,Co-Q,myoinositola one month washout period to be given before randomization.
排除标准
- •I.Husband with Teratozoospermia with morphology less than 2 %
- •II. Stage 3-4 endometriosis (ASRM classification)
- •III.hPoor ovarian less than 5Poseidon 3 and 4 category
- •IV.Any significant systemic disease or endocrine disorders like (Pituitary, Thyroid, Adrenal, Pancreas, Liver or Kidney) or any active condition requiring treatment which according to the investigator might interfere with the study.
- •V.Patients with severe uncontrolled diabetes mellitus.
- •VI.Untreated hyperprolactinemia.
- •VII.Abnormal bleeding of undetermined origin
- •VIII.Severe infections of reproductive tract like genital Tuberculosis and Sexually transmitted diseases.
- •IX.Known history of HIV/HbsAg/Hepatitis C.
- •X.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ
- •XI.Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments.
- •XII.Participation in the current or previous treatment with any approved or investigational health supplement(s) during the past 1 month.
研究者
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