Surgical and Non Surgical Treatment Option in Poly Cystic Ovary Cases

NCT ID: NCT05699356

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-11

Study Completion Date

2023-03-28

Brief Summary

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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

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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

Conditions

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Poly Cystic Ovary Treatment for Infertility

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Surgical treatment of Poly cystic ovary for infertility by laparoscopic drilling

laparoscopic drilling response in Poly Cystic Ovary case

laparoscopic drilling

Intervention Type PROCEDURE

Surgical intervension

Non-surgical treatment of Poly cystic ovary for infertility

induction,Anti estrogen,Insulin sensitizing agent, Aromatase Inhibitor,Gonadotropin

Non Surgical treatment

Intervention Type OTHER

Non Surgical

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 Life style modification

Intervention Type BEHAVIORAL

Non Surgical

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 Assisted reproductive technique

Intervention Type PROCEDURE

Surgical intervention

Treatment of Poly cystic ovary for infertility by controlling menstrual disorders

Controlling menstrual disorders response in Poly Cystic Ovary case for treatment of infertility

Non Surgical treatment

Intervention Type OTHER

Non Surgical

Treatment of Poly cystic ovary for infertility by Cutaneous manifestation

Cutaneous manifestation response in Poly Cystic Ovary case for treatment of infertility

Non Surgical treatment

Intervention Type OTHER

Non Surgical

Interventions

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Non Surgical treatment

Non Surgical

Intervention Type OTHER

laparoscopic drilling

Surgical intervension

Intervention Type PROCEDURE

Treatment of Poly cystic ovary for infertility by Life style modification

Non Surgical

Intervention Type BEHAVIORAL

Treatment of Poly cystic ovary for infertility by Assisted reproductive technique

Surgical intervention

Intervention Type PROCEDURE

Other Intervention Names

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Induction, Aromatase inhibitor,Insulin sensitizing agent,Gonadotropin,Anti estrogen Non surgical treatment option Surgical treatment option

Eligibility Criteria

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Inclusion Criteria

* Infertility cases with Poly Cystic Ovary sundrome

Exclusion Criteria

* Infertility cases not related with Poly cystic ovary
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Hawala Saleh Mohammed

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Suhag University hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hawala S Mohammed, Resident

Role: CONTACT

+201104354205

Yasser A Helmy, Professor

Role: CONTACT

+201226102105

Facility Contacts

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Magdi M Amini, Professor

Role: primary

Other Identifiers

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Soh-Med-22-10-03

Identifier Type: -

Identifier Source: org_study_id

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