NCT03412487

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

January 21, 2018

Last Update Submit

January 25, 2018

Conditions

Premature Ovarian Failure

Outcome Measures

Primary Outcomes (1)

  • presence of autoimuune oophoritis

    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

Study Arms (2)

premature ovarian failure

ACTIVE COMPARATOR

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

Control group

ACTIVE COMPARATOR

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

Interventions

laparoscopyPROCEDURE

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.

Control grouppremature ovarian failure

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed Maged, MD

    professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+2001005227404prof.ahmedmaged@gmail.com

Sahar Elbaradiee, MD

CONTACT

sbaradie@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 21, 2018

First Posted

January 26, 2018

Study Start

January 1, 2018

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations

EG(1)