Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03412487
Collaborator
(none)
50
1
2
12
4.2

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure and Its Relation to Thyroid Dysfunction
Anticipated Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. presence of autoimuune oophoritis [at time of laproscopy procedure]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kasr Alainy medical school Cairo Egypt 12151

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Ahmed Maged, MD, professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier:
NCT03412487
Other Study ID Numbers:
  • 21
First Posted:
Jan 26, 2018
Last Update Posted:
Jan 26, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2018