Efficacy of add-on Ayurveda and Yoga intervention on reproductive and metabolic outcomes in women with PCOS undergoing ovulation induction cycles: A multicentric randomized controlled trial- AYUR-YOG PCOS.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 402
- 试验地点
- 2
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Beyond the clinical and hormonal improvements, main outcome for infertile PCOS women is response to ovulation induction (OVI) treatments and pregnancy rates. Long term metabolic health is also one additional concern in these women. We could not find any study published on evaluation of effect of add-on Ayurveda and/or yoga intervention in addition to ovulation induction treatments on pregnancy rate among infertile PCOS women. The present study is being planned to study the effect of add-on ayurveda herb and yoga on clinical pregnancy rate in infertile PCOS women who are undergoing ovulation induction cycles. As no study has evaluated this before, the present study will give us novel results in form of effect of integrated ayurveda and yoga on clinical pregnancy rate in infertile PCOS women undergoing ovulation induction cycles. If proved to improve clinical pregnancy rates and additionally Quality of life assessment using PCOSQOL-I scale, then the add-on ayurveda and yoga may give an insight to integrate these two strategies as routine intervention tools along with starting OVI therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 38.00 Year(s)（—）
- 性别
- Female
入选标准
- •Infertile women attending Gynaecology OPD and meeting the Rotterdam criteria for diagnosis of PCOS.
- •1 Patient with oligo or anovulation with menstrual cycle length more than 35 days 2 Patient with clinical and or biochemical evidence of hyperandrogenism with mFG score greater than or equal to 5 3 serum testosterone greater than or equal to 0.56 ng per ml 4 free androgen index greater than 5 5 Patient with Follicle number per ovary greater than 19 and or ovarian volume greater than equal to 10cc in transvaginal scan done on day 2 to 5 Those having atleast 2 criteria will be labelled as PCOS and those with anovulation criterion with Phenotype A B D will be recruited for the study Other inclusion criteria will be A Normal husband semen parameters as per WHO semen analysis 2021 criteria B Patient with atleast one patent fallopian tube confirmed by hysterosalpingography or saline infusion sonography or laparoscopy C Patient with controlled thyroid disorders and normal prolactin levels.
排除标准
- •Patient with history of endometriosis 2.Patient is on any contraception or insulin treatment within last 3 months of recruitment 3.Patient with uncontrolled thyroid/prolactin disorder.
- •4.Those with history of laparoscopic ovarian drilling within last one year 5.Patient with non-classical congenital adrenal hyperplasia 6.Not willing for follow-up 7.Not having smart phone for doing online yoga classes.
结局指标
主要结局
Clinical pregnancy rate
时间窗: 7 weeks
次要结局
- Follicular response(14 days)
- Ongoing pregnancy rate(12 weeks)
- early abortion rate(12 weeks)
- Live birth rate(9 months)
- Quality of life assessment using PCOSQOL-I scale(0 & 24 weeks)
研究者
Reeta Mahey
AIIMS, New Delhi