Health Condition 1: N979- Female infertility, unspecified
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants aged between 21 to 40 years. 2. Patients having active marital life 3. Primary or secondary unexplained infertility And/Or Anovulatory (anovulation established by 2 anovulatory consecutive cycles on TVS) infertility. 4. Male partner with normal semen analysis (as per WHO 2010 criteria, within last 6 months) 5. At least one patent fallopian tube 6. Optimal Anti Mullerian Hormone level (as per the reference range of selected NABL lab) 7. Willing and able to participate in the study for 6 months and ready to provide informed written consent
Exclusion criteria
Exclusion criteria: 1. Anatomical abnormalities of reproductive tract 2. Structural pelvic pathologies (polyp, leiomyoma, Adenomyosis) 3. Bilateral fallopian tube blockage 4. Active diseases of reproductive tract like tuberculosis, carcinoma 5. Active sexually transmitted diseases 6. Hyperprolactinemia to the extent of S. Prolactin >50 ng/mL 7. Patients with severe backache & joint diseases. 8. Known cases of co-morbidities like uncontrolled diabetes mellitus (HbA1c >8%), uncontrolled hypertension (BP� 160/100 mm Hg), uncontrolled thyroid function, Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl), Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit), cardiac dysfunction or Immuno-compromised states like HIV 9. H/o hypersensitivity to the trial drug or any of its ingredients. 10. Patients on prolonged ( >6weeks) medication like corticosteroids, antidepressants, anticholinergics, OCPs, hormone replacement therapy etc. or any other chronic disorder or medications that may have an influence on the outcome of the study 11. Patients who have participated in any interventional study currently or have completed participation in any other clinical trial during the past three months since the day of screening 12. Any other condition that the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of follicular growth, ovulation rate & endometrial thickness (Based on serial TVS).Timepoint: for 6 consecutive menstrual cycles (1st month, 2nd month, 3rd month, 4th month, 5th month, 6th month) Follicular study on day 3rd, 11th, 13th, 15th, 17th, 19th, 21st day of menstrual cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ??? Clinical Pregnancy (considered as pregnancy diagnosed by ultrasound visualization of one or more gestational sacs or definitive clinical signs of pregnancy)Timepoint: 1 to 6 months of study;2. Effect on mental wellbeing and Quality of life (FertiQOL Tool -Hindi version and WHO-5 Well Being Index)Timepoint: Baseline, 90th day, 180th day of study;Assessment of adverse events and adverse drug reactionsTimepoint: baseline to 180th day of study;To predict the longitudinal outcomes of the research in advance and identify the factors that influence the outcomes of the interventions through machine learning modelsTimepoint: Baseline to 180th day of study | — |
Countries
India
Contacts
Public ContactDr Anubha Chandla
Central Council for Research in Ayurvedic Sciences
Outcome results
None listed