Clinical trial on general wellbeing in IVF subjects
- Registration Number
- CTRI/2021/10/037448
- Lead Sponsor
- Jagdale industries pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method i.Improvement in levels of sod,total antioxidant capacity in serum and follicular fluid <br/ ><br>ii.Number of morphologically mature oocytes retrieved (mii oocytes) <br/ ><br>iii.Number of top quality embryos <br/ ><br>Timepoint: Day0,Day2,Day8,Day14,Day28
- Secondary Outcome Measures
Name Time Method i.To check the total number of retrieved oocytes ,fertilization rate <br/ ><br>ii.To check any side effects of the drink <br/ ><br>Timepoint: Day0,Day2,Day8,Day14,Day28