PCOSNIL in Polycystic Ovarian Syndrome
- Conditions
- Health Condition 1: N970- Female infertility associated withanovulation
- Registration Number
- CTRI/2023/05/052746
- Lead Sponsor
- Acuere Biosciences PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Age â?? 18-45years.
2.Gender â?? Female.
3.Diagnosis of PCOS with Rotterdam criteria. (Any 2 of the 3)
a.Oligo/anovulation.
b.Hyperandrogenism.
i.Virilization.
ii.Sr. testosterone > 70 ng/dl
c.Polycystic ovaries on USG
i.Follicles >12 (measuring 2-9mm)
ii.Ovarian volume > 10 ml.
4.BMI > 25Kg/m2.
5.Ready to give written informed consent.
1.Haemoglobin < 10 g/dl
2.Known thyroid disorder TSH > 5mIU/L
3.DM fasting sugar > 150 mg/dl or HbA1c > 7.
4.Patient of DM on medication other than metformin.
5.Renal dysfunction creatinine > 1.4mg/dl or patients on dialysis
6.Liver enzymes (ALT, AST) normal or above the ULN (Upper Limit of Normal range but less than 3 times)
7.Known cardiovascular disease (Hypertensive/IHD/any other deformity â?? on medication). ECG QTc < 450ms.
8.On medication for any other disease in last 3 months.
9.Pregnancy and lactation.
10.Known case of Cushingâ??s syndrome.
11.Known case of primary adrenal hyperplasia.
12.Known case or H/O of HIV, Hepatitis B and Hepatitis C.
13.Any known case of malignancy.
14.Subjects on medications that may affect glucose metabolism such as corticosteroids.
15.Practicing dietary modification/dietary restrictions.
16.Patients on Phenytoin. (Interfere with androgenic activity)
17.Patients not willing to provide written consent.
18.Patients with a history of serious drug allergies (such as anaphylactic shock)
19.Participants not willing to use any form of contraception during the trial period.
20.Any disorder or clinically significant finding that may potentially impact the outcome measures as per the discretion of the study investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Insulin resistance â?? HOMA -IR (Homeostasis model assessment of Insulin resistance)Timepoint: time points will be <br/ ><br>1. Baseline. <br/ ><br>2. on completion of 12 weeks. <br/ ><br>3. On completion of 24 weeks.
- Secondary Outcome Measures
Name Time Method Change in testosterone levelsTimepoint: At 12 Weeks and 24 Weeks;Change in TNF â?? alphaTimepoint: At 12 Week and 24 Week;Change in WHRTimepoint: Every 4 Weeks;Change of FSH.Timepoint: At 12 Week and 24 Week;OvulationTimepoint: Every 4 weeks;Regulation of menstruationTimepoint: every 4 weeks;Change in AMHTimepoint: At 12 week and 24 week;Change in BMITimepoint: Every 4 Weeks;Change in FINS.Timepoint: At 12 weeks and 24 Weeks;Change in FPGTimepoint: At 12 Week and 24 Week;Change in LHTimepoint: At 12 weeks and 24 Weeks;Change in ProlactinTimepoint: At 12 week and 24 week