Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anti-Mullerian Hormone Deficiency
  • Female Infertility Endocrine
  • Polycystic Ovary Syndrome
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Recruited female with PCOS with 128 female with PCOS will be randomly divided into four parallel groups, yoga therapy (YT) group, aerobic exercise (AE) group, combined YT and AE (cYTAE) group and control groupMasking: Single (Outcomes Assessor)Masking Description: Lab technician who test the blood samples of the female with Polycystic Ovary Syndrome (PCOS) will be blinded to the trialPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 30 years
Gender
Only males

Description

A total of 128 female with PCOS will be recruited by the simple random sampling (random number generator) to participate in randomized, single blind randomized controlled, study. Recruited patients with 128 female with PCOS will be randomly divided into four groups, yoga therapy (YT) group, aerobic ...

A total of 128 female with PCOS will be recruited by the simple random sampling (random number generator) to participate in randomized, single blind randomized controlled, study. Recruited patients with 128 female with PCOS will be randomly divided into four groups, yoga therapy (YT) group, aerobic exercise (AE) group, combined YT and AE (cYTAE) group and control group. Duration of the intervention will be 60 minutes in one session for 6 days/week for 12 weeks. Thus, each women with PCOS will receive 72 sessions in total, except in control group. Anti-Müllerian hormone (AMH) and other biochemical markers such as, Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), Testosterone, Prolactin, Thyroid-stimulating hormone (TSH) Ultrasensitive, Dehydroepiandrosterone sulfate (DHEAS), insulin fasting, glucose fasting, HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) and the lipid profiles which includes, total cholesterol, High-density lipoprotein cholesterol (HDL-C), Low-density lipoprotein cholesterol (LDL-C) and serum triglycerides. In addition to the above biochemical markers, transvaginal ultrasound to estimate antral follicle count (AFC) will be recorded at baseline and at the end of 12-week post-intervention period. Following the 12-week intervention, follow-up of another 12-week will be carried out to determine the retention of treatment effects.

Tracking Information

NCT #
NCT04335227
Collaborators
Not Provided
Investigators
Principal Investigator: Asir J Samuel, MPT, PhD Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana Study Director: Unmesh Santpur, MBBS, MD Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana Study Chair: Kiranjeet Kaur, MBBS, MD Maharishi Markandeshwar Medical College & Hospital, Solan