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Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts

2. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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,

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Egypt
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egypt, 13512

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Postup: Laparoscopic Ovarian Cystectomy
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.
Ostatní jména:
  • Laparoscopic cystectomy; ovarian cyst removal; laparoscopic ovarian conservation surgery
Aktivní komparátor: 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.
Postup: Laparoscopic Ovarian Cystectomy
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.
Ostatní jména:
  • Laparoscopic cystectomy; ovarian cyst removal; laparoscopic ovarian conservation surgery

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Absolute Change in Serum Anti-Müllerian Hormone (AMH) Level
Časové okno: 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.
Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Preoperative AMH Cutoff Value Predicting Postoperative AMH ≥ 1 ng/ml
Časové okno: Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
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.
Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
Change in Antral Follicle Count (AFC)
Časové okno: 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.
Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
Change in Serum Follicle-Stimulating Hormone (FSH) Level
Časové okno: Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
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.
Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively
Correlation Between AMH Change and Clinical Variables
Časové okno: 3 months postoperatively
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.
3 months postoperatively
Intraoperative and Postoperative Complications
Časové okno: Intraoperative period, early postoperative period (24-48 hours), and up to 3 months postoperatively
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.
Intraoperative period, early postoperative period (24-48 hours), and up to 3 months postoperatively

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Operative Time
Časové okno: 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
Estimated Intraoperative Blood Loss
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Benha University

Vyšetřovatelé

  • Vrchní vyšetřovatel: AHMED ALNEZAMY, MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. června 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. září 2027

Termíny zápisu do studia

První předloženo

27. června 2026

První předloženo, které splnilo kritéria kontroly kvality

2. července 2026

První zveřejněno (Aktuální)

7. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MS 53.4.2026

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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