EndometriomaNCT02047838

Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas.

An observational study of Endometrioma and Endometriosis, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Endometrioma, Endometriosis, Surgery
What is being tested?: Anti-mullerian hormone (AMH) level dosage., Follicle-stimulating hormone (FSH) level dosage. and Antral follicle count (AFC).
How many people: 36 participants
Where: 1 siteItaly
Study dates: Jan 2007to Dec 2013
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
No healthy volunteers
Adult

Study population: In this study were recruited women referred to an academic centre for the diagnosis and treatment of endometriosis. Cases were patients undergoing second surgery for recurrent unilateral endometrioma. Controls were patients previously operated for unilateral endometrioma.

Who may be able to join

reproductive age (at the time of both surgical procedures);
two surgical procedures on the same ovary (stripping of endometrioma with
largest diameter ≥ 4 cm; cases) performed at our Institution;
one surgical procedures (stripping of endometrioma with largest diameter ≥ 4 cm; controls) performed at our Institution;
histological diagnosis of ovarian endometriomas;
complete assessment of ovarian reserve at routinary follow-up at our institution.

Who cannot join

patients aged ≥ 40 years at the time of primary surgery;
surgical procedures on the contralateral ovary (at primary or second-line surgery);
previous salpingectomy or hysterectomy;
unilateral ovariectomy at the time of first or second surgery;
ultrasonographic diagnosis of persistent endometrioma after first surgery;
additional surgical procedures for endometriomas or for other ovarian diseases before first surgery and between first and second surgery;

Show all 9Show fewer

hormonal treatment within 3 months from ovarian reserve assessment;
patients followed-up < 3 months after second-line surgery (for cases).
pregnancy and/or breastfeeding during the study period.

Trial locations and contacts

1 site in 1 country.

Italy1 site

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
Genoa, Ligury, 16122

Other trials in Italy

About this study

Official title: Impact on Ovarian Reserve of Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas: a Case-control Study.

This retrospective case-control study was performed in an Academic centre for the diagnosis and treatment of endometriosis. It included patients with recurrent unilateral endometriomas who were previously operated for the same condition (cases) and patients without recurrency who previously underwent surgery for unilateral endometrioma (controls). The primary outcome of the study was to assess the impact on ovarian reserve of second surgery for recurrent unilateral endometriomas. The evaluation of ovarian reserve was performed by assessing serum anti-mullerian hormone (AMH) level, serum follicle-stimulating hormone (FSH) level, 17-beta estradiol level and antral follicle count (AFC).

Conditions: Endometrioma, Endometriosis, Surgery
Being tested: Anti-mullerian hormone (AMH) level dosage., Follicle-stimulating hormone (FSH) level dosage., Antral follicle count (AFC).
Medical subject headings: Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anti-mullerian hormone (AMH) level dosage.Other
Follicle-stimulating hormone (FSH) level dosage.Other
Antral follicle count (AFC).Other

Study groups in NCT02047838
Study group	Role	What they receive
Cases.		Patients with recurrent unilateral endometrioma who were previously operated for the same condition. Receives: Other: Anti-mullerian hormone (AMH) level dosage.; Other: Follicle-stimulating hormone (FSH) level dosage.; Other: Antral follicle count (AFC).
Controls.		Patients previously operated for unilateral endometrioma without recurrence. Receives: Other: Anti-mullerian hormone (AMH) level dosage.; Other: Follicle-stimulating hormone (FSH) level dosage.; Other: Antral follicle count (AFC).

What is being measured

The primary outcome is the main question the study is designed to answer.

Anti-mullerian hormone (AMH) level.
Measured: In cases, anti-mullerian hormone (AMH) level was determined 3 months after second laparoscopic surgery. In controls, AMH levels was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).

Secondary outcomes (3)

Follicle-stimulating hormone (FSH) level.
Measured: In cases, follicle-stimulating hormone (FSH) level was determined 3 months after second laparoscopic surgery. In controls, FSH levels was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
17-beta estradiol level.
Measured: In cases, 17-beta estradiol level was determined 3 months after second laparoscopic surgery. In controls, 17-beta estradiol level was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
Antral follicle count (AFC).
Measured: In cases, antral follicle count (AFC) was determined 3 months after second laparoscopic surgery. In controls, antral follicle count was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Dec 2013

First posted28 Jan 2014 (estimated)
Study startJan 2007
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for EndometriomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02047838
Sponsor's protocol ID: Lillo 01/2014
Status last verified: Nov 2014
First submitted: 25 Jan 2014
Last updated: 25 Nov 2014
Results posted: No
Data monitoring committee: No

Publications

Ferrero S, Scala C, Racca A, Calanni L, Remorgida V, Venturini PL, Leone Roberti Maggiore U. Second surgery for recurrent unilateral endometriomas and impact on ovarian reserve: a case-control study. Fertil Steril. 2015 May;103(5):1236-43. doi: 10.1016/j.fertnstert.2015.01.032. Epub 2015 Feb 11.
PubMed 25681854

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Endometrioma, Ultrasound Therapy; Complications
Recruiting
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
Endometriosis
RecruitingObservational study
Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis.
Endometriosis
Not yet recruitingObservational study
Laparoscopic Sclerotherapy for the Management of Ovarian Endometriomas
Endometriosis, Endometrioma
RecruitingObservational study
Guangdong Provincial Endometriosis Clinical Research Cohort
Endometriosis

All Endometrioma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact on Ovarian Reserve of Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas: a Case-control Study.
ClinicalTrials.gov ID: NCT02047838
Acronym / sponsor ID: Lillo 01/2014
Conditions: Endometrioma, Endometriosis, Surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
Study start: Jan 2007
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 28 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Cases.	–	Other: Anti-mullerian hormone (AMH) level dosage., Other: Follicle-stimulating hormone (FSH) level dosage., Other: Antral follicle count (AFC).Patients with recurrent unilateral endometrioma who were previously operated for the same condition.
Controls.	–	Other: Anti-mullerian hormone (AMH) level dosage., Other: Follicle-stimulating hormone (FSH) level dosage., Other: Antral follicle count (AFC).Patients previously operated for unilateral endometrioma without recurrence.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult
Study population: In this study were recruited women referred to an academic centre for the diagnosis and treatment of endometriosis. Cases were patients undergoing second surgery for recurrent unilateral endometrioma. Controls were patients previously operated for unilateral endometrioma.

Key inclusion criteria (6 listed)

reproductive age (at the time of both surgical procedures);
two surgical procedures on the same ovary (stripping of endometrioma with
largest diameter ≥ 4 cm; cases) performed at our Institution;
one surgical procedures (stripping of endometrioma with largest diameter ≥ 4 cm; controls) performed at our Institution;
histological diagnosis of ovarian endometriomas;

Key exclusion criteria (9 listed)

patients aged ≥ 40 years at the time of primary surgery;
surgical procedures on the contralateral ovary (at primary or second-line surgery);
previous salpingectomy or hysterectomy;
unilateral ovariectomy at the time of first or second surgery;
ultrasonographic diagnosis of persistent endometrioma after first surgery;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anti-mullerian hormone (AMH) level dosage.	Other	Cases., Controls.
Follicle-stimulating hormone (FSH) level dosage.	Other	Cases., Controls.
Antral follicle count (AFC).	Other	Cases., Controls.

Primary outcome

Anti-mullerian hormone (AMH) level.
Time frame: In cases, anti-mullerian hormone (AMH) level was determined 3 months after second laparoscopic surgery. In controls, AMH levels was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).

3 secondary outcomes

Follicle-stimulating hormone (FSH) level.
Time frame: In cases, follicle-stimulating hormone (FSH) level was determined 3 months after second laparoscopic surgery. In controls, FSH levels was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
17-beta estradiol level.
Time frame: In cases, 17-beta estradiol level was determined 3 months after second laparoscopic surgery. In controls, 17-beta estradiol level was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
Antral follicle count (AFC).
Time frame: In cases, antral follicle count (AFC) was determined 3 months after second laparoscopic surgery. In controls, antral follicle count was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
Derived from this study: PubMed 25681854Ferrero S, Scala C, Racca A, Calanni L, Remorgida V, Venturini PL, Leone Roberti Maggiore U. Second surgery for recurrent unilateral endometriomas and impact on ovarian reserve: a case-control study. Fertil Steril. 2015 May;103(5):1236-43. doi: 10.1016/j.fertnstert.2015.01.032. Epub 2015 Feb 11.

Related trials for Endometrioma

Recruiting
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Endometrioma, Ultrasound Therapy; Complications
Recruiting
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
Endometriosis
RecruitingObservational study
Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis.
Endometriosis
Not yet recruitingObservational study
Laparoscopic Sclerotherapy for the Management of Ovarian Endometriomas
Endometriosis, Endometrioma
RecruitingObservational study
Guangdong Provincial Endometriosis Clinical Research Cohort
Endometriosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Simone Ferrero, PhD study director

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Umberto Leone Roberti Maggiore, MD principal investigator

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-mullerian hormone (AMH) level. (time frame: In cases, anti-mullerian hormone (AMH) level was determined 3 months after second laparoscopic surgery. In controls, AMH levels was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02047838, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2014.