Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure

Premature Ovarian Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03412487
• Other study ID #: 21
• Status: Not yet recruiting
• Phase: N/A
• First received: January 21, 2018
• Last updated: January 25, 2018
• Start date: January 2018
• Est. completion date: January 2019

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: +2001005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at time of laproscopy procedure