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Poly Cystic Ovary Treatment for InfertilityNCT05699356

Surgical and Non Surgical Treatment Option in Poly Cystic Ovary Cases

An observational study of Poly Cystic Ovary Treatment for Infertility, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Any age, women only
What is being tested?
Non Surgical treatment, laparoscopic drilling and Treatment of Poly cystic ovary for infertility by Life style modification
How many people
150 participants
Where
1 siteEgypt
Study dates
11 Oct 2022to 28 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Women in a child bearing age with poly cystic ovarian syndrome

Who may be able to join

  • Infertility cases with Poly Cystic Ovary sundrome

Who cannot join

  • Infertility cases not related with Poly cystic ovary

Trial locations and contacts

1 site in 1 country.

Hawala S Mohammed, Resident contact

+201104354205

aliyaahm55@gmail.com

Yasser A Helmy, Professor contact

+201226102105

helmy.yasser66@gmail.com

Egypt1 site, 1 recruiting
  • Suhag University hospital

    Sohag

    Magdi M Amini, Professor

    Recruiting

Other trials in Egypt

About this study

Official title: 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

Read the 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

Being tested
Non Surgical treatment, laparoscopic drilling, Treatment of Poly cystic ovary for infertility by Life style modification, Treatment of Poly cystic ovary for infertility by Assisted reproductive technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non Surgical treatmentOther

    Also called Induction, Aromatase inhibitor,Insulin sensitizing agent,Gonadotropin,Anti estrogen

    Non Surgical

  • laparoscopic drillingProcedure or surgery

    Surgical intervension

  • Treatment of Poly cystic ovary for infertility by Life style modificationBehavioural

    Also called Non surgical treatment option

    Non Surgical

  • Treatment of Poly cystic ovary for infertility by Assisted reproductive techniqueProcedure or surgery

    Also called Surgical treatment option

    Surgical intervention

Study groups in NCT05699356
Study groupRoleWhat they receive
Surgical treatment of Poly cystic ovary for infertility by laparoscopic drillinglaparoscopic drilling response in Poly Cystic Ovary case
Receives: Procedure: laparoscopic drilling
Non-surgical treatment of Poly cystic ovary for infertilityinduction,Anti estrogen,Insulin sensitizing agent, Aromatase Inhibitor,Gonadotropin
Receives: Other: Non Surgical treatment
Treatment of Poly cystic ovary for infertility by Life style modificationLife style modification response in Poly Cystic Ovary case for treatment of infertility
Receives: Behavioral: Treatment of Poly cystic ovary for infertility by Life style modification
Treatment of Poly cystic ovary for infertility by Assisted reproductive techniqueAssisted reproductive technique response in Poly Cystic Ovary case for treatment of infertility
Receives: Procedure: Treatment of Poly cystic ovary for infertility by Assisted reproductive technique
Treatment of Poly cystic ovary for infertility by controlling menstrual disordersControlling menstrual disorders response in Poly Cystic Ovary case for treatment of infertility
Receives: Other: Non Surgical treatment
Treatment of Poly cystic ovary for infertility by Cutaneous manifestationCutaneous manifestation response in Poly Cystic Ovary case for treatment of infertility
Receives: Other: Non Surgical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of ovulation after life modification

    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

    Measured: 6 months

  2. Rate of ovulation by medical treatment like Clomifene Citrate and Letrozole

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

    Measured: 6 months

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

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start11 Oct 2022
  3. Primary completion20 Mar 2023 (estimated)
  4. Study completion28 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05699356
Sponsor's protocol ID
Soh-Med-22-10-03
Status last verified
Jan 2023
First submitted
18 Oct 2022
Last updated
26 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Poly Cystic Ovary Treatment for Infertility, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hawala S Mohammed, Resident (+201104354205, aliyaahm55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of ovulation after life modification (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.

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