Surgical and Non Surgical Treatment Option in Poly Cystic Ovary Cases

Recruiting

• Conditions: Poly Cystic Ovary Treatment for Infertility
• Interventions: Other: Non Surgical treatment; Procedure: laparoscopic drilling; Behavioral: Treatment of Poly cystic ovary for infertility by Life style modification; Procedure: Treatment of Poly cystic ovary for infertility by Assisted reproductive technique

• Registration Number: NCT05699356
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-10-11
• Study First Submitted: 2022-10-18
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-25
• Last Update Submitted: 2023-01-25
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Infertility cases with Poly Cystic Ovary sundrome

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Exclusion Criteria

• Infertility cases not related with Poly cystic ovary

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment of Poly cystic ovary for infertility by Cutaneous manifestation	Non Surgical treatment	Cutaneous manifestation response in Poly Cystic Ovary case for treatment of infertility
Surgical treatment of Poly cystic ovary for infertility by laparoscopic drilling	laparoscopic drilling	laparoscopic drilling response in Poly Cystic Ovary case
Non-surgical treatment of Poly cystic ovary for infertility	Non Surgical treatment	induction,Anti estrogen,Insulin sensitizing agent, Aromatase Inhibitor,Gonadotropin
Treatment of Poly cystic ovary for infertility by Life style modification	Treatment of Poly cystic ovary for infertility by Life style modification	Life style modification response in Poly Cystic Ovary case for treatment of infertility
Treatment of Poly cystic ovary for infertility by Assisted reproductive technique	Treatment of Poly cystic ovary for infertility by Assisted reproductive technique	Assisted reproductive technique response in Poly Cystic Ovary case for treatment of infertility
Treatment of Poly cystic ovary for infertility by controlling menstrual disorders	Non Surgical treatment	Controlling menstrual disorders response in Poly Cystic Ovary case for treatment of infertility

Primary Outcome Measures

Name	Time	Method
The rate of ovulation after life modification	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)	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	6 months	The study also will focus on different medical treatment method like Clomifene Citrate, lentrozole for induction in ovulation

Trial Locations

Locations (1)

Suhag University hospital; 🇪🇬 Sohag, Egypt