Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure
Primary Purpose
Premature Ovarian Failure
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Premature Ovarian Failure
Eligibility Criteria
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.
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
premature ovarian failure
Control group
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
presence of autoimuune oophoritis
Autoimmune oophritis was assessed by quantifying LCA positive cells in ovarian stroma as follows:
[Type text] 0= not convincing.
mild autoimmune oophritis.
moderate autoimmune oophritis.
sever autoimmune oophritis.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03412487
Brief Title
Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure
Official Title
Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure and Its Relation to Thyroid Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
premature ovarian failure
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
laparoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
presence of autoimuune oophoritis
Description
Autoimmune oophritis was assessed by quantifying LCA positive cells in ovarian stroma as follows:
[Type text] 0= not convincing.
mild autoimmune oophritis.
moderate autoimmune oophritis.
sever autoimmune oophritis.
Time Frame
at time of laproscopy procedure
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
+2001005227404
Email
prof.ahmedmaged@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sahar Elbaradiee, MD
Email
sbaradie@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure
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