Clinical trial on general wellbeing in IVF subjects

A Prospective, Open Label, Multi-Center Study To Evaluate The Safety And Efficacy Of Supplementation With Mulmina Amla Orange Health Drink In IVF Patients

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037448

Enrollment

Registered

2021-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Mulmina Amla Orange Health Drink: Dose: 200ml drink Dosage form: Oral Drink Frequency : 2 packs per day for 4 weeks Route of administrate : Orally Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
i.Improvement in levels of sod,total antioxidant capacity in serum and follicular fluid ii.Number of morphologically mature oocytes retrieved (mii oocytes) iii.Number of top quality embryos Timepoint: Day0,Day2,Day8,Day14,Day28	—

Secondary

Measure	Time frame
i.To check the total number of retrieved oocytes ,fertilization rate ii.To check any side effects of the drink Timepoint: Day0,Day2,Day8,Day14,Day28	—

Countries

India

Contacts

Public ContactMr Raghavendra K V

Radiant Research Services Pvt Ltd

ashok@radiantresearch.in9880999297

Outcome results