Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts
2. juli 2026 opdateret af: Ahmed Abdel Latif Ahmed Alnezamy, Benha University
Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts: A Comparative Prospective Cohort Study
We will conduct this study to estimate the effect of laparoscopic cystectomy on ovarian reserve in endometriotic cysts versus non-endometriotic cysts.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
After eligibility and consenting, all participants aged 18-45 years presented to Benha University or the Endometriosis center with ovarian cyst diagnosed via transvaginal ultrasound or MRI will undergo laparoscopic ovarian cystectomy.
Data will be collected regarding,
- Baseline clinical data will be collected by healthcare providers including age, BMI, parity, previous pelvic surgery, duration and type of infertility, duration of cyst once diagnosed till time of laparoscopic surgery, laterality of cyst and size.
Baseline ovarian reserve will include
- AMH will be measured within 1 month before laparoscopic surgery.
- AFC will be measured within 1 month preoperative via transvaginal ultrasound in the early follicular phase of the menstrual cycle (cycle days 2-4).
- FSH will be measured within 1 month preoperative between day (2 and 4) of the menstrual cycle.
Intraoperative data will be collected by trained operating room nurse including:
- Operative time which is the time lapse between insertion of Veress needle trocar for preparation till the removal of the 10 mm umbilical trocar.
Estimated intraoperative blood loss(mL) where it calculated by
= (Total weight of wet gauze after surgery (g) - Total weight of dry gauze before surgery (g)) + (Amount of fluid in suction bucket (g) - Weight of flushing fluid (g)used)
- laterality of the Cyst, number of cauterizations, cyst rupture, adverse effects including soft tissue or organ injury.
Postoperative follow up
- Early postoperative follow up with first 24-48 hours during hospital admission recording complications such as fever, intraperitoneal hemorrhage or postoperative pain calculated by NPRS (Numeric Pain Rating Scale) (0-10) where 0 mean no pain and 10 mean intense or intolerable pain or through VAS (Visual Analogue Scale).
- Longterm complications will be structurally soliced via telephone calls every 2 weeks till the end of the follow-up period including fever, surgical site infection, readmission or reoperation.
- At 3-month postoperative AMH, FSH will be re-evaluated at the same laboratory, and AFC will be re-evaluated by the same ultrasonography.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: AHMED ALNEZAMY, MD
- Telefonnummer: 01224849065
- E-mail: AHMED.ALNZAMY@fmed.bu.edu.eg
Studiesteder
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-
Qalyubia Governorate
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Banhā, Qalyubia Governorate, Egypten, 13512
- Rekruttering
- Benha Univesity Hospital
-
Kontakt:
- AHMED ALNEZAMY, MD
- Telefonnummer: 00201224849065
- E-mail: AHMED.ALNZAMY@fmed.bu.edu.eg
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Female patients aged 18-45 years
- Ovarian cyst measuring 6-15 cm in diameter, confirmed by transvaginal ultrasound or MRI
- Cyst is persistent for more than 3 months if asymptomatic, OR any symptomatic cyst regardless of duration of diagnosis
- Serum anti-Müllerian hormone (AMH) level ≥ 2 ng/mL, measured within 1 month preoperatively
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- Clinical or ultrasonic suspicion of ovarian malignancy
- Ovarian cyst associated with pregnancy
- Previous history of ovarian surgery
- History of pelvic irradiation or chemotherapy
- Known endocrine disorders affecting ovarian function (e.g., PCOS, premature ovarian insufficiency, thyroid dysfunction, hyperprolactinemia)
- Current use of hormonal contraceptives or hormonal therapy within 3 months prior to enrollment
- Presence of severe systemic disease that contraindicates surgery or general anesthesia
- Refusal to participate or inability to provide informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Endometriotic Cyst Group
Patients with endometriotic ovarian cysts (endometriomas) diagnosed by transvaginal ultrasound or MRI, confirmed by histopathological examination postoperatively.
Participants will undergo laparoscopic ovarian cystectomy under general anesthesia.
The procedure involves excision of the cyst wall from adjacent ovarian tissue using traction with grasping forceps, hemostasis achieved via electrocoagulation or sutures, and plication of ovarian incision edges.
Any visible endometriotic lesions within the pelvic cavity will be excised or cauterized as appropriate.
All patients will be followed up at 3 months postoperatively with serum AMH, FSH, and transvaginal ultrasound for AFC assessment.
|
Laparoscopic excision of ovarian cyst under general anesthesia.
The procedure includes: (1) CO₂ pneumoperitoneum creation via Veress needle through a 1-cm umbilical incision until intraabdominal pressure reaches 15 mmHg; (2) insertion of a 10-mm umbilical trocar and telescope; (3) placement of two or more 5-mm ancillary trocars under direct visualization; (4) incision of the ovarian capsule using monopolar scissors; (5) identification and careful dissection of the cyst wall from adjacent ovarian tissue using traction with grasping forceps; (6) hemostasis achieved using electrocoagulation or sutures; (7) plication and approximation of the ovarian incision edges; (8) for endometriosis cases, excision or cauterization of visible endometriotic lesions; (9) histopathological examination of the excised specimen to confirm diagnosis.
The procedure is performed in both arms (endometriotic and non-endometriotic cysts) using identical surgical techniques.
Andre navne:
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Aktiv komparator: Non-Endometriotic Cyst Group
Patients with non-endometriotic benign ovarian cysts (including dermoid cysts, serous cystadenomas, mucinous cystadenomas, and other benign cysts) diagnosed by transvaginal ultrasound or MRI, confirmed by histopathological examination postoperatively.
Participants will undergo laparoscopic ovarian cystectomy under general anesthesia.
The procedure involves excision of the cyst wall from adjacent ovarian tissue using traction with grasping forceps, hemostasis achieved via electrocoagulation or sutures, and plication of ovarian incision edges.
All patients will be followed up at 3 months postoperatively with serum AMH, FSH, and transvaginal ultrasound for AFC assessment.
|
Laparoscopic excision of ovarian cyst under general anesthesia.
The procedure includes: (1) CO₂ pneumoperitoneum creation via Veress needle through a 1-cm umbilical incision until intraabdominal pressure reaches 15 mmHg; (2) insertion of a 10-mm umbilical trocar and telescope; (3) placement of two or more 5-mm ancillary trocars under direct visualization; (4) incision of the ovarian capsule using monopolar scissors; (5) identification and careful dissection of the cyst wall from adjacent ovarian tissue using traction with grasping forceps; (6) hemostasis achieved using electrocoagulation or sutures; (7) plication and approximation of the ovarian incision edges; (8) for endometriosis cases, excision or cauterization of visible endometriotic lesions; (9) histopathological examination of the excised specimen to confirm diagnosis.
The procedure is performed in both arms (endometriotic and non-endometriotic cysts) using identical surgical techniques.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Absolute Change in Serum Anti-Müllerian Hormone (AMH) Level
Tidsramme: Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
|
The absolute change in serum anti-Müllerian hormone (AMH) level from baseline to 3 months after laparoscopic ovarian cystectomy, calculated as the difference between preoperative AMH value (measured within 1 month before surgery) and postoperative AMH value (measured at 3 months after surgery).
Comparison will be made between the endometriotic cyst group and the non-endometriotic cyst group.
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Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Preoperative AMH Cutoff Value Predicting Postoperative AMH ≥ 1 ng/ml
Tidsramme: Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
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Receiver operating characteristic (ROC) curve analysis to determine the optimal preoperative serum AMH cutoff value that predicts maintenance of serum AMH ≥ 1 ng/ml at 3 months postoperatively.
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) will be calculated.
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Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
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Change in Antral Follicle Count (AFC)
Tidsramme: Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
|
The change in antral follicle count (AFC) from baseline to 3 months after laparoscopic ovarian cystectomy, assessed via transvaginal ultrasound in the early follicular phase (cycle days 2-4).
Comparison will be made between endometriotic and non-endometriotic cyst groups.
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Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
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Change in Serum Follicle-Stimulating Hormone (FSH) Level
Tidsramme: Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
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The change in serum follicle-stimulating hormone (FSH) level from baseline to 3 months after laparoscopic ovarian cystectomy, measured on cycle days 2-4.
Comparison will be made between endometriotic and non-endometriotic cyst groups.
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Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
|
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Correlation Between AMH Change and Clinical Variables
Tidsramme: 3 months postoperatively
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Analysis of the correlation between the change in serum AMH level and various clinical variables, including number of cauterizations, cyst size (cm), laterality (unilateral/bilateral), cyst type (endometriotic/non-endometriotic), age (years), and body mass index (BMI, kg/m²).
Pearson or Spearman's rank correlation coefficients will be calculated as appropriate.
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3 months postoperatively
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Intraoperative and Postoperative Complications
Tidsramme: Intraoperative period, early postoperative period (24-48 hours), and up to 3 months postoperatively
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Description and comparison of intraoperative and postoperative complications between the endometriotic and non-endometriotic cyst groups, including: intraoperative cyst rupture, organ injury (bladder, bowel, uterus, fallopian tubes, major blood vessels), hemorrhage; early postoperative complications (within 24-48 hours) including fever, intraperitoneal hemorrhage, and postoperative pain measured by NPRS (0-10) or VAS; and long-term complications (up to 3 months) including surgical site infection, readmission, reoperation, and cyst persistence or recurrence.
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Intraoperative period, early postoperative period (24-48 hours), and up to 3 months postoperatively
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Operative Time
Tidsramme: Intraoperative period
|
Comparison of operative time (minutes) between the endometriotic and non-endometriotic cyst groups.
Operative time is defined as the time lapse between insertion of the Veress needle trocar for preparation until the removal of the 10 mm umbilical trocar.
|
Intraoperative period
|
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Estimated Intraoperative Blood Loss
Tidsramme: Intraoperative period
|
Comparison of estimated intraoperative blood loss (mL) between the endometriotic and non-endometriotic cyst groups.
Blood loss will be calculated as: (Total weight of wet gauze after surgery in grams - Total weight of dry gauze before surgery in grams) + (Amount of fluid in suction bucket in grams - Weight of flushing fluid used in grams).
|
Intraoperative period
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: AHMED ALNEZAMY, MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kindan A, Kindan A, Kurt A, Akbulut VO, Dilbaz B. Effects of benign ovarian cyst volume and laterality on AMH and CA-125 levels. BMC Womens Health. 2025 Jul 4;25(1):305. doi: 10.1186/s12905-025-03842-9.
- Woodward PJ, Sohaey R, Mezzetti TP Jr. Endometriosis: radiologic-pathologic correlation. Radiographics. 2001 Jan-Feb;21(1):193-216; questionnaire 288-94. doi: 10.1148/radiographics.21.1.g01ja14193.
- Wu Q, Yang Q, Lin Y, Wu L, Lin T. The optimal time for laparoscopic excision of ovarian endometrioma: a prospective randomized controlled trial. Reprod Biol Endocrinol. 2023 Jun 27;21(1):59. doi: 10.1186/s12958-023-01109-2.
- Younis JS, Shapso N, Fleming R, Ben-Shlomo I, Izhaki I. Impact of unilateral versus bilateral ovarian endometriotic cystectomy on ovarian reserve: a systematic review and meta-analysis. Hum Reprod Update. 2019 May 1;25(3):375-391. doi: 10.1093/humupd/dmy049.
- Iwase A, Hirokawa W, Goto M, Takikawa S, Nagatomo Y, Nakahara T, Manabe S, Kikkawa F. Serum anti-Mullerian hormone level is a useful marker for evaluating the impact of laparoscopic cystectomy on ovarian reserve. Fertil Steril. 2010 Dec;94(7):2846-9. doi: 10.1016/j.fertnstert.2010.06.010. Epub 2010 Jul 14.
- Mansouri G, Safinataj M, Shahesmaeili A, Allahqoli L, Salehiniya H, Alkatout I. Effect of laparoscopic cystectomy on ovarian reserve in patients with ovarian cyst. Front Endocrinol (Lausanne). 2022 Aug 30;13:964229. doi: 10.3389/fendo.2022.964229. eCollection 2022.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. juni 2026
Primær færdiggørelse (Anslået)
1. juni 2027
Studieafslutning (Anslået)
1. september 2027
Datoer for studieregistrering
Først indsendt
27. juni 2026
Først indsendt, der opfyldte QC-kriterier
2. juli 2026
Først opslået (Faktiske)
7. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MS 53.4.2026
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