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.
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
- Conditions the study is for
- Poly Cystic Ovary Treatment for Infertility
- What is being tested?
- Non Surgical treatment, laparoscopic drilling and Treatment of Poly cystic ovary for infertility by Life style modification
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- 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.
Egypt1 site, 1 recruiting
- Recruiting
Suhag University hospital
Sohag
Magdi M Amini, Professor
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 group | Role | What they receive |
|---|---|---|
| Surgical treatment of Poly cystic ovary for infertility by laparoscopic drilling | laparoscopic drilling response in Poly Cystic Ovary case Receives: Procedure: laparoscopic drilling | |
| Non-surgical treatment of Poly cystic ovary for infertility | induction,Anti estrogen,Insulin sensitizing agent, Aromatase Inhibitor,Gonadotropin Receives: Other: Non Surgical treatment | |
| Treatment of Poly cystic ovary for infertility by Life style modification | Life 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 technique | Assisted 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 disorders | Controlling 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 manifestation | Cutaneous 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.
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
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
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.
- First posted26 Jan 2023
- Study start11 Oct 2022
- Primary completion20 Mar 2023 (estimated)
- Study completion28 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poly Cystic Ovary Treatment for InfertilityStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hawala Saleh Mohammed, Sohag University
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Non Surgical Treatment Option in Poly Cystic Ovary Cases, A Meta Analysis Study
- ClinicalTrials.gov ID
- NCT05699356
- Acronym / sponsor ID
- Soh-Med-22-10-03
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 28 Mar 2023 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment of Poly cystic ovary for infertility by laparoscopic drilling | – | Procedure: laparoscopic drillinglaparoscopic drilling response in Poly Cystic Ovary case |
| Non-surgical treatment of Poly cystic ovary for infertility | – | Other: Non Surgical treatmentinduction,Anti estrogen,Insulin sensitizing agent, Aromatase Inhibitor,Gonadotropin |
| Treatment of Poly cystic ovary for infertility by Life style modification | – | Behavioral: Treatment of Poly cystic ovary for infertility by Life style modificationLife style modification response in Poly Cystic Ovary case for treatment of infertility |
| Treatment of Poly cystic ovary for infertility by Assisted reproductive technique | – | Procedure: Treatment of Poly cystic ovary for infertility by Assisted reproductive techniqueAssisted reproductive technique response in Poly Cystic Ovary case for treatment of infertility |
| Treatment of Poly cystic ovary for infertility by controlling menstrual disorders | – | Other: Non Surgical treatmentControlling menstrual disorders response in Poly Cystic Ovary case for treatment of infertility |
| Treatment of Poly cystic ovary for infertility by Cutaneous manifestation | – | Other: Non Surgical treatmentCutaneous manifestation response in Poly Cystic Ovary case for treatment of infertility |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women in a child bearing age with poly cystic ovarian syndrome
Key inclusion criteria (1 listed)
- Infertility cases with Poly Cystic Ovary sundrome
Key exclusion criteria (1 listed)
- Infertility cases not related with Poly cystic ovary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Surgical treatmentAlso: Induction, Aromatase inhibitor,Insulin sensitizing agent,Gonadotropin,Anti estrogenNon Surgical | Other | Non-surgical treatment of Poly cystic ovary for infertility, Treatment of Poly cystic ovary for infertility by Cutaneous manifestation, Treatment of Poly cystic ovary for infertility by controlling menstrual disorders |
| laparoscopic drillingSurgical intervension | Procedure or surgery | Surgical treatment of Poly cystic ovary for infertility by laparoscopic drilling |
| Treatment of Poly cystic ovary for infertility by Life style modificationAlso: Non surgical treatment optionNon Surgical | Behavioural | Treatment of Poly cystic ovary for infertility by Life style modification |
| Treatment of Poly cystic ovary for infertility by Assisted reproductive techniqueAlso: Surgical treatment optionSurgical intervention | Procedure or surgery | Treatment of Poly cystic ovary for infertility by Assisted reproductive technique |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.