utritional supplement for women with Polycystic Ovary Syndrome or subfertilty

Phase 3

• Conditions: Health Condition 1: null- Polycystic Ovary Syndrome and or Subfertilty in Women

• Registration Number: CTRI/2012/08/002943
• Lead Sponsor: Meyer Organics Pvt Ltd Thane

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 104

Inclusion Criteria

Young women of age between 18 to 38 yrs with PCOS [Presence of any two of the following parameters: (Roterdam criteria 2003)

Oligomenorrhea and/or anovulation.

Subjects with Hyperandrogenism. (clinical and/or biochemical) (Ferriman-Gallwey score >8; biological (LH/FSH ratio >2]

OR

Subfertile females

Sexually active and male partner with potential of produce a child

Polycystic ovaries with exclusion of other etiologies.

Women with normal uterine cavity

Subjects with Impaired Glucose Tolerance or Insulin Resistance.

Normal physical activity confirmed with physical and clinical examination, and routine laboratory tests, including AST, ALT, hematology routine urinalysis and measurement of oral temperature and vital signs.

Exclusion Criteria

Pregnant or lactating women.

Subjects with presence of infertility factors other than anovulation

Subjects with pelvic organic pathologies, presence of other pathologies such as non-classical congenital adrenal hyperplacia, cushingâ??s syndrome and androgen secreting tumors,

Subjects with thyroid dysfunction, hyprolactenemia, androgen secreting neoplacia.

Women requiring, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and antiobesity drugs, or other hormonal drugs.

Subjects taking vitamins & micronutrient supplementation at the time of screening.

Subjects with any neoplastic, metabolic, and cardiovascular disorder or other concurrent medical illness (i.e. type 1 or type 2 diabetes, renal disease, and malabsorptive disorders, acute and chronic inflammations) confirmed based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis.

Subjects with known history of hypersensitivity to the study drugs.

Alcoholic consumers and smokers

Study & Design

• Study Type: Interventional
• Study Design: Not specified