CClinicalTrials.gg
Status unknownNCT05699356Updated Jan 26, 2023

Surgical and Non Surgical Treatment Option in Poly Cystic Ovary Cases

An observational study in Poly Cystic Ovary Treatment for Infertility, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2023-01-26.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
150
Sex
Female
01

Study 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 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

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Conditions studied

  • Poly Cystic Ovary Treatment for Infertility
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In context

Ovarian Cysts

73 studies on the registry are indexed under Ovarian Cysts; 15 are open to participants now.

This study's planned enrollment of 150 is close to the median of 160 across 25 observational studies indexed under Ovarian Cysts.

Browse Ovarian Cysts studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women in a child bearing age with poly cystic ovarian syndrome

Inclusion criteria

  • Infertility cases with Poly Cystic Ovary sundrome

Exclusion criteria

Exclusion Criteria:

  • Infertility cases not related with Poly cystic ovary
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Surgical treatment of Poly cystic ovary for infertility by laparoscopic drilling

    laparoscopic drilling response in Poly Cystic Ovary case

    Procedure: laparoscopic drilling

  • Non-surgical treatment of Poly cystic ovary for infertility

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

    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

    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

    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

    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

    Other: Non Surgical treatment

Interventions

  • OtherNon Surgical treatment

    Non Surgical

    Also known as: Induction, Aromatase inhibitor,Insulin sensitizing agent,Gonadotropin,Anti estrogen

  • Procedurelaparoscopic drilling

    Surgical intervension

  • BehavioralTreatment of Poly cystic ovary for infertility by Life style modification

    Non Surgical

    Also known as: Non surgical treatment option

  • ProcedureTreatment of Poly cystic ovary for infertility by Assisted reproductive technique

    Surgical intervention

    Also known as: Surgical treatment option

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What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Suhag University hospital
    Sohag, Egypt
    • Magdi M Amini, Professor · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05699356
Lead sponsor
Sohag University
Responsible party
Hawala Saleh Mohammed (Resident, Sohag University) — Principal investigator
First posted
Jan 26, 2023
Start date
Oct 11, 2022
Primary completion
Mar 20, 2023 (estimated)
Completion
Mar 28, 2023 (estimated)
Last update
Jan 26, 2023

Study contacts

Hawala S Mohammed, Resident
Contact
aliyaahm55@gmail.com
+201104354205
Yasser A Helmy, Professor
Contact
helmy.yasser66@gmail.com
+201226102105

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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