Clinical trial NCT01808170: Laparoscopic Ovarian Cystectomy of Endometrioma vs Deroofing and Ovarian Reserve
Official title: Effect of Laparoscopic Ovarian Cystectomy of Endometrioma Versus Cyst Deroofing on Ovarian Reserve as Determined by Anti-mullerian Hormone and Antral Follicle Count: a Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrioma
Keywords: Laparoscopy
AMH
AFC
Endometrioma
ovarian reserve
Ovarian cystectomy
ovarian cyst deroofing
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-03-11
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus laparoscopic cyst deroofing on ovarian reserve measured by serum levels of anti mullerian hormone and antral follicle count in patients with endometriomas.

Detailed description: One of the major concerns about excision of endometriomas is their negative effect on ovarian reserve because of follicle loss, removal of endometriomas has been associated with poorer performance in IVF procedures, and decreased ovarian volumes have also been reported after surgery.Ovarian reserve is defined as the functional potential of the ovary which reflects the number and quality of the follicles left in the ovary, and is well-correlated with the response to ovarian stimulation using exogenous gonadotrophin. Over the years, various tests and markers of ovarian reserve have been reported; the static tests include serum markers, such as basal FSH, inhibin-B and anti-Mullerian hormone (AMH), and ultrasonographic markers, such as ovarian volume and antral follicle count.This study will include 122 patients aged between 18 and 35 years who have been diagnosed with endometrioma (unilateral or bilateral) and they are candidates for laparoscopic surgery. They will be selected according to inclusion and exclusion criteria.they will be randomized into two study groups, one study group will undergo laparoscopic ovarian cystectomy, the other study group will undergo laparoscopic cyst deroofing.AMH,AFC and ovarian volume will be measured pre-operative and post-operative.

Eligibility criteria: Inclusion Criteria:

1. Age from 18-35 year
2. Regular menstrual cycles.
3. Endometrioma (unilateral or bilateral) diagnosed by transvaginal ultrasound with diameter ≥ 3 cm.

Exclusion criteria:

1. Any previous ovarian surgery.
2. Evidence of polycystic ovary syndrome according to Rotterdam criteria

   -Two of three of:
   * Oligo- or chronic anovulation.
   * Clinical and/or biochemical signs of hyperandrogenism.
   * Polycystic ovaries.
3. Evidence of premature ovarian failure diagnosed by follicle stimulating hormone level ≥40 IU/L
4. Any endocrinal disease affecting ovarian function e.g. thyroid dysfunction, hyperprolactinemia.
5. Previous hormonal medications e.g. oral contraceptive pills, gonadotropin-releasing hormone analogue within the last 3 months before surgery.
6. Any suspicious findings of ovarian malignant diseases diagnosed by transvaginal ultrasound.
7. Contraindication to surgery.

Primary outcomes:
measure: comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by alteration of AMH level in endometrioma patients.
timeFrame: 17 months
Secondary outcomes:
measure: comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by antral follicle count estimation in endometrioma patients.
timeFrame: 17 months
measure: comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by ovarian volume estimation in endometrioma patients.
timeFrame: 17 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Assistant professor of Obstetrics & Gynecology, faculty of medicine, AinShams University
name: Ahmed K. Makled, M.D.
role: STUDY_DIRECTOR
affiliation: Lecturer Obstetics & Gynecolog, faculty of medicine, AinShams University
name: Mohamed S. Sweed, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: AinShams University
name: Neveen S. Mehanna, M.B.B.CH.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sweed MS, Makled AK, El-Sayed MA, Shawky ME, Abd-Elhady HA, Mansour AM, Mohamed RM, Hemeda H, Nasr-Eldin EA, Attia NS, Eltaieb E, Allam H, Hussein A. Ovarian Reserve Following Laparoscopic Ovarian Cystectomy vs Cyst Deroofing for Endometriomas. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):877-882. doi: 10.1016/j.jmig.2018.06.022. Epub 2018 Sep 5.