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The Association Between Endometriosis, Obesity and nesfatin1

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ClinicalTrials.gov Identifier: NCT02683954
Recruitment Status : Completed
First Posted : February 17, 2016
Results First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital

Brief Summary:
The association between endometriosis, obesity and nesfatin1.

Condition or disease
Endometriosis

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

    -67-

  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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Association Bet Endometriosis, Obesity and nesfatin1
Study Start Date : December 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort
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.
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.



Primary Outcome Measures :
  1. Serum Nesfatin 1 [ Time Frame: 24 hours ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
sixty female patients were admitted to the wards to undergo laparoscopy for various indications
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.
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Responsible Party: Amr Ahmed Mahmoud Riad, Lecturer of obstetrics and gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02683954    
Other Study ID Numbers: nesfatin 1
First Posted: February 17, 2016    Key Record Dates
Results First Posted: April 4, 2016
Last Update Posted: April 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Endometriosis