Trial Title:
Surgical and Non Surgical Treatment Option in Poly Cystic Ovary Cases
NCT ID:
NCT05699356
Condition:
Poly Cystic Ovary Treatment for Infertility
Conditions: Official terms:
Ovarian Cysts
Infertility
Estrogens
Aromatase Inhibitors
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Non Surgical treatment
Description:
Non Surgical
Arm group label:
Non-surgical treatment of Poly cystic ovary for infertility
Arm group label:
Treatment of Poly cystic ovary for infertility by Cutaneous manifestation
Arm group label:
Treatment of Poly cystic ovary for infertility by controlling menstrual disorders
Other name:
Induction, Aromatase inhibitor,Insulin sensitizing agent,Gonadotropin,Anti estrogen
Intervention type:
Procedure
Intervention name:
laparoscopic drilling
Description:
Surgical intervension
Arm group label:
Surgical treatment of Poly cystic ovary for infertility by laparoscopic drilling
Intervention type:
Behavioral
Intervention name:
Treatment of Poly cystic ovary for infertility by Life style modification
Description:
Non Surgical
Arm group label:
Treatment of Poly cystic ovary for infertility by Life style modification
Other name:
Non surgical treatment option
Intervention type:
Procedure
Intervention name:
Treatment of Poly cystic ovary for infertility by Assisted reproductive technique
Description:
Surgical intervention
Arm group label:
Treatment of Poly cystic ovary for infertility by Assisted reproductive technique
Other name:
Surgical treatment option
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
Criteria for eligibility:
Study pop:
Women in a child bearing age with poly cystic ovarian syndrome
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Infertility cases with Poly Cystic Ovary sundrome
Exclusion Criteria:
- Infertility cases not related with Poly cystic ovary
Gender:
Female
Gender based:
Yes
Gender description:
females on child bearing age
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Suhag University hospital
Address:
City:
Sohag
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Magdi M Amini, Professor
Start date:
October 11, 2022
Completion date:
March 28, 2023
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05699356
https://go.drugbank.com/drugs/DB00882
