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Completed

NCT Number: NCT03109964

The Affect of Hemostasis Technique During Laparoscopic Ovarian Cystectomy on Future Fertility

Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.

Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2), Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian volume and antral follicle count.

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Key information

Conditions

Cyst Ovary Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam health care campus

Haifa, Israel

About this study

Patients undergoing elective laparoscopic ovarian cystectomy will be recruited after signing an informed consent, and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.

Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including FSH, LH, E2, Progesterone and AMH levels, and sonographic evaluation of ovarian volume and antral follicle count.

Antral follicle count will be performed on the cyst post-surgery using light microscopy. The difference in hormone levels, especially AMH reflects the damage done during surgery to the ovarian reserve. Sonographic signs including a decrease in ovarian volume and antral follicle count also reflect the damage done during surgery to the ovarian reserve.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients with benign ovarian cysts that are interested in future fertility ages 18-44.

Exclusion criteria

  • Female patients with malignant ovarian cysts/masses.

Treatment and study plan

Bipolar coagulation forceps (ETHICON inc.)

Device

Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.

SURGIFLO hemostatic matrix (ETHICON inc.)

Device

Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.

Primary outcomes

  1. Decline in ovarian reserve.

    Time frame: Up to 6 months.

    Decline rate of AMH levels before and 6 months after surgery.

Secondary outcomes

  1. Sonographic decline in ovarian volume

    Time frame: Up to 6 months

    Decline rate of ovarian volume before and 6 months after surgery.

  2. Sonographic decline in ovarian antral follicle count

    Time frame: Up to 6 months

    Decline rate of ovarian antral follicle count before and 6 months after surgery.

  3. Changes in FSH levels

    Time frame: Up to 6 months.

    Changes in FSH levels before and 6 months after surgery.

  4. Changes in LH levels

    Time frame: Up to 6 months

    Changes in LH levels before and 6 months after surgery.

  5. Changes in Progesterone levels

    Time frame: Up to 6 months

    Changes in Progesterone levels before and 6 months after surgery.

  6. Changes in E2 levels

    Time frame: Up to 6 months

    Changes in E2 levels before and 6 months after surgery.

  7. Number of antral follicles in the cyst removed from the ovary.

    Time frame: Up to 6 months.

    Number of antral follicles in the cyst removed from the ovary as seen utilizing light microscopy.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

The Affect of Hemostasis With Bipolar Coagulation Versus SURGIFLO Placement on Ovarian Reserve and Future Fertility

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Apr 12, 2017
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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