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Structured yoga therapy program for 60 minutes six days per week for 12 weeks and nutritional management uniquely prepared by dietitian

Aerobic training of moderate intensity for 30-60 minutes six days per week for 12 weeks and nutritional management uniquely prepared by dietitian

Combined yoga therapy for three days and vigorous aerobic exercise program for three days with nutritional management uniquely prepared by dietitian

Nutritional management uniquely prepared by dietitian

Structured yoga therapy prepared according to traditional yoga scriptures of Patanjali yoga sutras will be administered to 32 females with PCOS. The structured yoga therapy which includes, Surya Namaskara (Sun Salutation) and asanas performed in four positions, standing, sitting, supine and prone for total duration of 60 minutes. In addition to this, they will be asked to undergo nutritional management uniquely prepared by dietitian

Structured yoga therapy program

Thirty two females with PCOS in aerobic exercise (AE) group will be subjected to aerobic training of moderate intensity for 30-60 minutes six days per week for 12 weeks, in the light of guidelines framed by American College of Sports Medicine (ACSM). Aerobic exercise volume for each female recruited will be set at greater than 500 and up to 1000 MET-min/week, which will be approximately equal to 1000 kcal/week. They will be made sure that they exercise for minimum duration of 150 min/week and thereby covering 5400 to 7900 steps/day in pedometer readings. In addition to this, they will be asked to undergo nutritional management uniquely prepared by dietitian

Aerobic exercise training program

Thirty two females with PCOS in combined yoga therapy and aerobic exercise (cYTAE) group will be subjected to three days of structured yoga therapy and three days of aerobic training of vigorous intensity. In addition to this, they will be asked to undergo nutritional management uniquely prepared by dietitian

Combined yoga and aerobic training program

Thirty two females with PCOS will be asked to undergo only nutritional management uniquely prepared by dietitian

Nutritional management

Asir J Samuel, MPT, PhD

Unmesh Santpur, MBBS, MD

Kiranjeet Kaur, MBBS, MD

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.

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.

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

Lab technician who test the blood samples of the female with Polycystic Ovary Syndrome (PCOS) will be blinded to the trial

Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone in Young Women With Polycystic Ovary Syndrome

Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone and Other Biochemical Markers in Young Women With Polycystic Ovary Syndrome

Serum Anti-Mullerian hormone will be determined by blinded lab technician

Antral follicle count will be determined by blinded gynaecologist

Serum Follicle-stimulating hormone will be determined by blinded lab technician

Serum Luteinizing hormone will be determined by blinded lab technician

Serum Testosterone will be determined by blinded lab technician

Serum Prolactin will be determined by blinded lab technician

Serum Thyroid-stimulating hormone will be determined by blinded lab technician

Serum Dehydroepiandrosterone sulfate will be determined by blinded lab technician

Serum Insulin fasting will be determined by blinded lab technician

Serum Glucose fasting will be determined by blinded lab technician

Homeostatic Model Assessment for Insulin Resistance will be determined by blinded lab technician

Serum total cholesterol, Serum High-density lipoprotein cholesterol, Serum Low-density lipoprotein cholesterol and serum triglycerides

Maharishi Markendeswar University (Deemed to be University)

Associate Professor

Pathological Conditions, Anatomical

The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy.

The secondary objective is the analysis of predictors of change in the ovarian reserve after surgery

The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve

The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve : A Prospective Study

Corporacion Parc Tauli

Coagulants

Hemostatics

Hormone Antagonists

Four punctures in each ovary were done regardless of the level of antimullerian hormone

The number of ovarian drills was adjusted according to antimullerian hormone level

The electric current used was set at 40 Watts. The power was activated just before touching the ovary, and then the needle electrode was held against the antimesenteric surface of the ovary for 4 seconds until penetration of the ovarian capsule. Four or eight puncture points were made through the ovarian capsule of each ovary according to the study protocol. The ovaries were cooled in the pool of the Ringer's lactate after each cauterization both to minimize adhesion formation and to prevent heat trauma to the adjacent viscera. Complete hemostasis was ensured. At the end of the procedure, the ovaries were copiously rinsed with Ringer's lactate (Aqua-purator, Storz, Germany). An amount about 200 ml of heparinized Ringers lactate (5000 IU/1000 ml) was left in the pelvis to avoid postoperative adhesions.

Laparoscopic ovarian drilling

1. In patients with Antimullerian hormone between 4-8 ng/ml 4 punctures in each ovary were performed.
2. In patients with Antimullerian hormone above 8 ng/ml 8 punctures in each ovary were performed.

Antimullerian hormone

In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity. At that time wedge resection of the ovaries was introduced on an empirical basis and proved a successful treatment for the associated anovulation and infertility. In the ensuing fifty years the limitations of a purely surgical approach to therapy have become recognized and the importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary Syndrome: The prevalence of polycystic ovary syndrome in any specified population is dependent upon the diagnostic criteria used, but does have some regional and ethnic variation. While most reports on the prevalence of polycystic ovary syndrome range between 2 and 20%, the chosen diagnostic criteria are recognized to influence the determined prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been done to use the level of anti-mullerian hormone as a factor for planning the number of ovarian drills in each ovary.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone in Young Women With Polycystic Ovary Syndrome	NCT04335227	Polycystic Ovar... Anti-Mullerian ... Female Infertil...	Structured yoga... Aerobic exercis... Combined yoga a... Nutritional man...	18 Years - 30 Years	Maharishi Markendeswar University (Deemed to be University)
The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve	NCT02852447	Antimullerian H... Ovarian Cysts Antral Follicle...		15 Years - 40 Years	Corporacion Parc Tauli
Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome	NCT03237312	Polycystic Ovar...	Laparoscopic ov... Antimullerian h...	20 Years - 35 Years	Assiut University

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