Surgical and Non Surgical Treatment Option in Poly Cystic Ovary Cases

January 25, 2023 updated by: Hawala Saleh Mohammed, Sohag University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Suhag University hospital
        • Contact:
          • Magdi M Amini, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women in a child bearing age with poly cystic ovarian syndrome

Description

Inclusion Criteria:

  • Infertility cases with Poly Cystic Ovary sundrome

Exclusion Criteria:

  • Infertility cases not related with Poly cystic ovary

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical treatment of Poly cystic ovary for infertility by laparoscopic drilling
laparoscopic drilling response in Poly Cystic Ovary case
Procedure: laparoscopic drilling
Surgical intervension
Non-surgical treatment of Poly cystic ovary for infertility
induction,Anti estrogen,Insulin sensitizing agent, Aromatase Inhibitor,Gonadotropin
Other: Non Surgical treatment
Non Surgical
Other Names:
  • Induction, Aromatase inhibitor,Insulin sensitizing agent,Gonadotropin,Anti estrogen
Treatment of Poly cystic ovary for infertility by Life style modification
Life style modification response in Poly Cystic Ovary case for treatment of infertility
Behavioral: Treatment of Poly cystic ovary for infertility by Life style modification
Non Surgical
Other Names:
  • Non surgical treatment option
Treatment of Poly cystic ovary for infertility by Assisted reproductive technique
Assisted reproductive technique response in Poly Cystic Ovary case for treatment of infertility
Procedure: Treatment of Poly cystic ovary for infertility by Assisted reproductive technique
Surgical intervention
Other Names:
  • Surgical treatment option
Treatment of Poly cystic ovary for infertility by controlling menstrual disorders
Controlling menstrual disorders response in Poly Cystic Ovary case for treatment of infertility
Other: Non Surgical treatment
Non Surgical
Other Names:
  • Induction, Aromatase inhibitor,Insulin sensitizing agent,Gonadotropin,Anti estrogen
Treatment of Poly cystic ovary for infertility by Cutaneous manifestation
Cutaneous manifestation response in Poly Cystic Ovary case for treatment of infertility
Other: Non Surgical treatment
Non Surgical
Other Names:
  • Induction, Aromatase inhibitor,Insulin sensitizing agent,Gonadotropin,Anti estrogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of ovulation after life modification
Time Frame: 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
6 months
Rate of ovulation by medical treatment like Clomifene Citrate and Letrozole
Time Frame: 6 months
The study also will focus on different medical treatment method like Clomifene Citrate, lentrozole for induction in ovulation
6 months
Rate of regular ovulation after laparoscopic Ovarian drilling (Surgical treatment)
Time Frame: 6 months
The surgery is done to remove part of ovary through laparoscopy which results ovary to restore normal ovulation
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Anticipated)

March 20, 2023

Study Completion (Anticipated)

March 28, 2023

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-10-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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