The Association Between Endometriosis, Obesity and nesfatin1

NCT ID: NCT02683954

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-10-31

Brief Summary

The association between endometriosis, obesity and nesfatin1.

Detailed Description

All women in this study were subjected to all of the following:

1. Verbal consent was obtained.

2. History taking:

1. Personal history.

2. Menstrual history.

3. Use of contraception.

4. Use of any hormonal treatment in the three months prior to the laparoscopy.

5. History of infertility and its duration and type.

6. Sexual history.

7. Past history.

3. Complete physical examination: general, abdominal and local gynecological examination.

4. Complete preoperative workout for laparoscopy was done.

5. Laparoscopy was done postmenstrual, during follicular phase. All patients gave an informed consent and were fasting for at least 8 hours prior to the laparoscopy, and general anesthesia was used for all patients.

The pelvis and its structures were observed and checked for presence of endometriotic lesions (uterus, tubes, ovaries and ovarian fossae, uterosacral ligaments, Douglas pouch, uterovesical pouch, broad ligaments and lateral pelvic walls).

The Endometriotic patients were then classified into stages I-IV according to the revised American Fertility Society scoring system for endometriosis.

6. Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients during the laparoscopy procedure immediately after initial evaluation and before any intervention.

7. Biopsy from lesions suspected as endometriosis was taken during laparoscopy and sent to histopathology for confirmation.

8. The blood samples were centrifuged immediately after their collection at 5000 rpm for 10 min and serum samples were stored at -20 °C until analysis.

Patients and Methods

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9. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay "ELISA" technique using commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits, Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals.

Conditions

Endometriosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

endometriosis

30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI \<25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.

No interventions assigned to this group

control

30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI \<25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Women in reproductive age group scheduled for laparoscopy for any indication.

Exclusion Criteria

• Women subject to any hormonal therapy in the last 3 months.
• Women with chronic endocrine disease like diabetes mellitus.
• Women diagnosed with pelvic inflammatory disease (PID).
• Severe medical disorder that prohibits the laparoscopic procedure, such as cardiovascular disease and pulmonary disease.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amr Ahmed Mahmoud Riad

Lecturer of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

nesfatin 1

Identifier Type: -

Identifier Source: org_study_id