Antimullerian HormoneNCT02852447
The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve
An observational study of Antimullerian Hormone and Ovarian Cysts, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy. The secondary objective is the analysis of predictors of change in the ovarian reserve after surgery Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Antimullerian Hormone, Ovarian Cysts, Antral Follicle Count
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to Dec 2016
- 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 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients with bening ovarian cyst and requiring surgical removal
Who may be able to join
- Patients with non endometriosis ovarian cysts
- Age between 15-40 years
- Regulars menses
- Signed informed consent
Who cannot join
- Patients with Previous surgery,
- Patients with infertility,
- Patients with endometriosis or
- Patients with suspicious of malignance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve : A Prospective Study
The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy.
The secondary objective is the analysis of predictors of change in the ovarian reserve after surgery
- Conditions
- Antimullerian Hormone, Ovarian Cysts, Antral Follicle Count
- Medical subject headings
- Ovarian Cysts
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in the ovarian reserve before and after surgery by Antimullerian Hormone
Measured: 3 months
differences in the ovarian reserve before and after surgery by Antral Follicle Count
Measured: 3 months
Secondary outcomes (4)
Ovarian Size (mm)
Measured: 3 months
Time of surgery (minutes)
Measured: 3 months
Age (years)
Measured: 3 months
BMI in kg/m2
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startNov 2014
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimullerian HormoneStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Costa-Canals, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852447
- Sponsor's protocol ID
- CPT-GINE-2016
- Status last verified
- Feb 2017
- First submitted
- 1 Jul 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve : A Prospective Study
- ClinicalTrials.gov ID
- NCT02852447
- Acronym / sponsor ID
- CPT-GINE-2016
- Conditions
- Antimullerian Hormone, Ovarian Cysts, Antral Follicle Count
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Aug 2016 (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.
The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy.
The secondary objective is the analysis of predictors of change in the ovarian reserve after surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with bening ovarian cyst and requiring surgical removal
Key inclusion criteria (4 listed)
- Patients with non endometriosis ovarian cysts
- Age between 15-40 years
- Regulars menses
- Signed informed consent
Key exclusion criteria (4 listed)
- Patients with Previous surgery,
- Patients with infertility,
- Patients with endometriosis or
- Patients with suspicious of malignance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
differences in the ovarian reserve before and after surgery by Antimullerian Hormone
Time frame: 3 months
differences in the ovarian reserve before and after surgery by Antral Follicle Count
Time frame: 3 months
4 secondary outcomes
Ovarian Size (mm)
Time frame: 3 months
Time of surgery (minutes)
Time frame: 3 months
Age (years)
Time frame: 3 months
BMI in kg/m2
Time frame: 3 months
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 23 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antimullerian Hormone and Ovarian Cysts, run by Corporacion Parc Tauli at 1 site in Spain.
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 4 inclusion and 4 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 23 Feb 2017. 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 Spain. 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?
differences in the ovarian reserve before and after surgery by Antimullerian Hormone (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2017.