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The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

S

Saad Amer

Status

Unknown

Conditions

Endometriosis

Treatments

Procedure: Surgery for ovarian endometrioma

Study type

Interventional

Funder types

Other

Identifiers

NCT01425333
R&D: DHRD/2010/089

Details and patient eligibility

About

The aim of this study is to assess which of two commonly used surgical procedures in the treatment of ovarian cysts called endometriomas (cutting out of the cyst - "cystectomy", or draining it and cauterising it's inner lining - "ablation") causes the least damage to the ovary and is therefore best at maintaining the future fertility potential of a patient.

Enrollment

20 estimated patients

Sex

Female

Ages

18 to 42 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Women undergoing laparoscopic surgery for treatment of unilateral endometriomas measuring ≥ 3cm and ≤ 8cm in diameter

Exclusion criteria

  • Patients who have received oestrogen suppressing drugs (e.g. oral contraceptive pills, GnRHa) during the previous six months
  • Patients who have previously undergone surgical treatment of endometriomas
  • Patients with bilateral endometriomas
  • Patients with endometriomas of less than 3cm in size or more than 8cm in size
  • Pre-surgical evidence of reduced ovarian reserve
  • Pregnant patients
  • Patients unable to give informed consent e.g. patients with mental incapacity

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Cystectomy
Active Comparator group
Description:
Patients undergoing cystectomy for ovarian endometrioma
Treatment:
Procedure: Surgery for ovarian endometrioma
Procedure: Surgery for ovarian endometrioma
Ablation
Active Comparator group
Description:
Patients undergoing ablation for ovarian endometrioma
Treatment:
Procedure: Surgery for ovarian endometrioma
Procedure: Surgery for ovarian endometrioma

Trial contacts and locations

1

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Central trial contact

Saad Amer, MD, MRCOG

Data sourced from clinicaltrials.gov

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