Clinical trial NCT04335227: Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone in Young Women With Polycystic Ovary Syndrome
Official title: Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone and Other Biochemical Markers in Young Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Anti-Mullerian Hormone Deficiency
Female Infertility Endocrine
Keywords: Yoga therapy
Aerobic exercise training
Aerobic exercise
Aerobic training
Polycystic ovary syndrome
Antimullerian hormone
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 group
Primary purpose: TREATMENT

Brief summary: Weight loss and lifestyle modifications are much required in women with Polycystic ovarian syndrome (PCOS). Yoga has gained great importance as an alternate medicine in recent years which is helpful in lifestyle modifications. Weight loss can be achieved by regular aerobic activity. In recent years, excessive production of anti-mullerian hormone (AMH) has been considered as the etiology of PCOS. AMH is also emerging as a diagnostic and screening tool for PCOS. Effect of yoga therapy on adolescent girls have proved to be effective. But, researches on young women undergoing yoga therapy and combined effect of aerobic exercise and yoga therapy are still lacking. Hence, the investigators aimed t o establish the benefits of yoga therapy and aerobic exercise on Anti-Mullerian Hormone and other biochemical markers in young women with polycystic ovary syndrome.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Female in age between 18 and 30 years
* Female with at least two-thirds of the features listed in the Rotterdam criteria for PCOS were included in the study
* Oligomenorrhea or amenorrhea (an absence of menstruation for 45 or more days and/or fewer than 9 menses per year)
* Hyperandrogenism (a score of 8 or higher ( ≥ 8) on the modified Ferriman-Gallwey scale)
* Polycystic ovaries (presence of more than 12 cysts \< 9 mm in diameter in single ovary, usually combined with an ovarian volume \> 10 ml

Exclusion Criteria:

* On regular hormonal treatment
* Oral contraceptives
* Insulin-sensitizing agents in the previous 6 weeks
* Smoking in less than 48 hours
* Alcohol in less than 48 hours
* History of thyroid abnormalities
* Practicing regular yoga asanas and pranayama
* Regular aerobic training program

Primary outcomes:
measure: Serum Anti-Mullerian hormone Concentration
timeFrame: Change from Baseline Serum Anti-Mullerian hormone Concentration at 12 weeks
Secondary outcomes:
measure: Antral follicle count
timeFrame: Change from Baseline Antral follicle count at 12 weeks
measure: Serum Follicle-stimulating hormone Concentration
timeFrame: Change from Baseline Serum Follicle-stimulating hormone Concentration at 12 weeks
measure: Serum Luteinizing hormone Concentration
timeFrame: Change from Baseline Serum Luteinizing hormone Concentration at 12 weeks
measure: Serum Testosterone Concentration
timeFrame: Change from Baseline Serum Testosterone Concentration at 12 weeks
measure: Serum Prolactin Concentration
timeFrame: Change from Baseline Serum Prolactin Concentration at 12 weeks
measure: Serum Thyroid-stimulating hormone Concentration
timeFrame: Change from Baseline Serum Thyroid-stimulating hormone Concentration at 12 weeks
measure: Serum Dehydroepiandrosterone sulfate Concentration
timeFrame: Change from Baseline Serum Dehydroepiandrosterone sulfate Concentration at 12 weeks
measure: Serum Insulin fasting Concentration
timeFrame: Change from Baseline Serum Insulin fasting Concentration at 12 weeks
measure: Serum Glucose fasting Concentration
timeFrame: Change from Baseline Serum Glucose fasting Concentration at 12 weeks
measure: Homeostatic Model Assessment for Insulin Resistance
timeFrame: Change from Baseline Homeostatic Model Assessment for Insulin Resistance at 12 weeks
measure: Concentration of Lipid profiles in serum
timeFrame: Change from Baseline Concentration of Lipid profiles in serum at 12 weeks
Other outcomes:
Locations:
city: Ambala
country: India
facility: Maharishi Markandeshwar Hospital, Mullana
state: Haryana
city: Solan
country: India
facility: Maharishi Markandeshwar Medical College & Hospital, Kumarhatti
state: Himachal Pradesh
Study officials:
affiliation: Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana
name: Asir J Samuel, MPT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana
name: Unmesh Santpur, MBBS, MD
role: STUDY_DIRECTOR
affiliation: Maharishi Markandeshwar Medical College & Hospital, Solan
name: Kiranjeet Kaur, MBBS, MD
role: STUDY_CHAIR
References: