Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure

January 25, 2018 updated by: Ahmed Maged, Cairo University

Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure and Its Relation to Thyroid Dysfunction

25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).

*Pelvic laparoscopy and ovarian biopsy will be done ovarian biopsy preparation

For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).Pelvic laparoscopy and ovarian biopsy To be examined histologically. All procedures were performed under general anesthesia the utero-ovarian ligament was stabilized with the round biopter introduced through the other. The round metal biopter 5 mm in diameter with an inner protective trocar.

The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness. The round biopter was removed, and a grasper was introduced to recover the excised tissue.

Ovarian biopsy specimens were fixed in 10% formalin and embedded in paraffin forming tissue blocks. Two sections, 4μ thick were cut from each block. One was stained with routine haematoxylin and eosin (H&E) stain while the other was immunostained with anti-Leukocyte Common Antigen (LCA).

For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt, 12151
        • Kasr Alainy Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Woman under age of 40y.

    • Infertility.
    • History of oligomenorrhea or amenorrhea for 1 year or more FSH level >20 IU/L at least 2 occasions 4-6 weeks apart (FSH level 20-40 IU/L indicates ovarian insufficiency, while level above 40 IU/L indicates complete failure).
    • History of thyroid dysfunction, postpartum thyroiditis and or thyroid surgery.
    • Symptoms or signs suggestive of thyroid dysfunction or goiter.
    • Family history of thyroid dysfunction or goiter.
    • Presence of thyroid antibodies or other antibodies.
    • Type 1 Diabetes Mellitus.
    • Prior irradiation to head and neck

Exclusion Criteria:

  • Women above 40 yrs.

    • Follicle stimulating hormone (FSH) less than 20mIU/mL
    • Women using hormonal treatement, exposed to radiation to abdomen or pelvis, chemotherapy, or ovarian surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: premature ovarian failure
women under 40 years old with History of oligomenorrhea or amenorrhea for 1 year or more FSH level >20 IU/L at least 2 occasions 4-6 weeks apart (FSH level 20-40 IU/L indicates ovarian insufficiency, while level above 40 IU/L indicates complete failure).
Procedure: laparoscopy
under general anesthesia. CO2 pneumoperitoneum, the laparoscope inserted through the umbilicus and a thorough evaluation of the abdominal cavity and pelvis was performed. a grasper was inserted; the utero-ovarian ligament was stabilized with the round biopter will be introduced. The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness.
Active Comparator: Control group
A group of female patients presented with infertility but with regular menses and normal ovarian function (according to history, general examination, gynecological examination and FSH level).
Procedure: laparoscopy
under general anesthesia. CO2 pneumoperitoneum, the laparoscope inserted through the umbilicus and a thorough evaluation of the abdominal cavity and pelvis was performed. a grasper was inserted; the utero-ovarian ligament was stabilized with the round biopter will be introduced. The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
presence of autoimuune oophoritis
Time Frame: at time of laproscopy procedure

Autoimmune oophritis was assessed by quantifying LCA positive cells in ovarian stroma as follows:

[Type text] 0= not convincing.

  1. mild autoimmune oophritis.
  2. moderate autoimmune oophritis.
  3. sever autoimmune oophritis.
at time of laproscopy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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