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Status unknownNCT01425333Updated Aug 30, 2011

The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

An interventional study of Surgery for ovarian endometrioma and Surgery for ovarian endometrioma in Endometriosis, sponsored by Saad Amer. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-30.

Sponsored by Saad Amer · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 42 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Endometriosis

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Keywords

  • Ovarian endometriomas
  • Laparoscopy
  • Cystectomy
  • Ablation
03

In context

Endometriosis

925 studies on the registry are indexed under Endometriosis; 264 are open to participants now.

This study's planned enrollment of 20 is below the median of 65 across 539 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

This is the only study on the registry with Saad Amer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Cystectomy

    Patients undergoing cystectomy for ovarian endometrioma

    Procedure: Surgery for ovarian endometrioma

  • Active comparator
    Ablation

    Patients undergoing ablation for ovarian endometrioma

    Procedure: Surgery for ovarian endometrioma

Interventions

  • ProcedureSurgery for ovarian endometrioma

    Patients undergoing surgery for ovarian endometrioma

    Also known as: Patients undergoing cystectomy for ovarian endometrioma

  • ProcedureSurgery for ovarian endometrioma

    Patients undergoing surgery for ovarian endometrioma

    Also known as: Patients undergoing cystectomy for ovarian endometrioma

06

What researchers measure

Primary outcomes

  1. Anti-Mullerian Hormone (AMH)

    Change in anti-mullerian hormone level after surgery (at one week, three months and six months)

    Time frame: 6 months post-operatively

Secondary outcomes

  1. Follicle Stimulating Hormone (FSH)

    Change in follicle stimulating hormone levels after surgery (at one week, three months and six months)

    Time frame: 6 months

  2. Antral Follicle Count (AFC)

    Change in AFC after surgery (at three months)

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Royal Derby Hospital
    Derby, DE22 3NE, United Kingdom
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01425333
Lead sponsor
Saad Amer
Collaborators
University Hospitals of Derby and Burton NHS Foundation Trust
Responsible party
Saad Amer (Associate Professor in Gynaecology, University Hospitals of Derby and Burton NHS Foundation Trust) — Sponsor-investigator
First posted
Aug 30, 2011
Start date
Apr 2011
Primary completion
Aug 2012 (estimated)
Completion
Feb 2013 (estimated)
Last update
Aug 30, 2011

Study contacts

Saad Amer, MD, MRCOG
Contact
saad@amer@nottigham.ac.uk
+44(1332)724612
Saad Amer, MD, MRCOG
principal investigator · University of Nottingham and Derby Hospitals NHS foundation Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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