The Association Between Endometriosis, Obesity and nesfatin1

Endometriosis Clinical Trial

Official title:

The Association Bet Endometriosis, Obesity and nesfatin1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683954
• Other study ID #: nesfatin 1
• Status: Completed
• Phase: N/A
• First received: February 12, 2016
• Last updated: February 16, 2016
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational

Clinical Trial Summary

The association between endometriosis, obesity and nesfatin1.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum nesfatin 1	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.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. 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.	24 hours	Yes