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临床试验/NCT05699356
NCT05699356招募中不适用

Surgical and Non Surgical Treatment Option in Poly Cystic Ovary Cases, A Meta Analysis Study

Sohag University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
The rate of ovulation after life modification

研究概览

简要总结

The study will focus on treatment of Poly Cystic Ovary Syndrome patients with infertility The aim is to to find the best treatment by comparison of surgical and non surgical intervention

详细描述

INTRODUCTION Infertility is the failure of couples to conceive after one year of having regular unprotected coitus 1, 2&3 Globally there are 48 -186 million people cases reported with infertility. The common causes of infertility are being male factor, tubal peritoneal factor, cervical mucus, an ovulatory disorders and others causes including anti-sperm antibodies, luteal phase deficiency, diabetic mellitus, genital tract infection 1,2&4 Infertility is often multifactorial so during treatment multiple investigations should be conducted 2 Anovulation cover 30% of all infertility cases, is a complex process by which there is a failure of ovary to release mature ovarian follicles and involves a lot of potential causes 2&5 The clinical symptoms of anovulating cycles are irregular periods, light or heavy menses, deficiency of cervical mucus, Irregular Basal Body Temperature (BBT) 2&5 The common causes of anovulatory cycle is Polycystic Ovarian Syndrome (PCOS), other causes are due to hypothalamus or pituitary gland dysfunction, Premature ovarian failure, high serum estradiol in follicular phase, age above 45, hyper prolactinemia, subclinical hypothyroidism, drugs, luteinized unruptured follicles, Diabetes mellitus, athletic activity and people who do not eat and become very slim 1,2&5 Polycystic Ovarian Syndrome (PCOS) is a condition in a female of child bearing age characterized by menstrual disorders, hyperandrogenism, multiple ovarian cysts and anovulatory cycle 6 The causes of this condition are idiopathic, but the following reasons are highly suggested to be associated with PCO 6&7 Insulin resistance develop from excess insulin lead the body to produce more androgen and causing anovulatory cycle 6 women with PCOS have low grade inflammation that stimulates Poly cystic ovaries to produce androgen which can lead changes in blood vessels and heart 6 PCOS also may be due familiar susceptibility 6 The sign and symptoms of PCO are Menstrual disorders including missed period more than 35 days, infrequent period less 9 menses in a year, irregular menses light or heavy period 6&7 Hyperandrogenism manifestation like hirsutism, clitoromegaly, masculinization, severe acne, in severe form of PCO (hyperthecosis) there is deepening of voice 6, 7&8 History of infertility due to intermittently ovulation, the condition also is associate with higher chance of miscarriage 8 Polycystic ovaries presence of numerous small cysts filled with fluid in the ovaries 6&7 Majority of PCO patients are obese which worsen the symptoms of PCO 6&8 About 10 % of PCO cases have type 2 Diabetic Mellitus and 30-40 % at age of 40 have impaired glucose tolerance test 8 Sleep apnea which predispose PCO affected patients to cardiovascular disease 8 COMPLICATION OF PCO Infertility, gestational diabetes, Pregnancy induce hypertension, abortion or pre term birth, steatohepatitis, cardiovascular disease, Type 2 diabetes or prediabetes, lack of sleep, depression, thinning of hair, anxiety and eating disorder, abnormal uterine bleeding, acanthosis nigricans, armpit and under breasts, endometrial cancer a1 a2 The treatment of PCO is widely including life style modification, drug treatment, FDA safety alerts, metabolic derangements, anovulation, hirsutism, diet and activity, surgical intervention a3

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Infertility cases with Poly Cystic Ovary sundrome

排除标准

  • Infertility cases not related with Poly cystic ovary

结局指标

主要结局

The rate of ovulation after life modification

时间窗: 6 months

The study will focus on different methods of health modification like health eating, exercise and weight loss and their ability to keep hormones in normal ranges and cause ovulation

Rate of regular ovulation after laparoscopic Ovarian drilling (Surgical treatment)

时间窗: 6 months

The surgery is done to remove part of ovary through laparoscopy which results ovary to restore normal ovulation

Rate of ovulation by medical treatment like Clomifene Citrate and Letrozole

时间窗: 6 months

The study also will focus on different medical treatment method like Clomifene Citrate, lentrozole for induction in ovulation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hawala Saleh Mohammed

Resident

Sohag University

研究点 (1)

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