EndometriosisENDOVOCNCT03352661
Influence of an Endometrioma on Oocyte Quality
An observational study of Endometriosis, run by IVI Vigo.
Trial summary
The purpose of this study is to evaluate if there are differences in oocyte quality depending on whether these oocytes come from an ovary in contact with an endometrioma. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Collect retrospectively data
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2018
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients <40 years, BMI <30kg / m2,
Who may be able to join
- Patients <40 years, BMI <30kg / m2,
Who cannot join
- -
About this study
The purpose of this study is to evaluate if there are differences in oocyte quality depending on whether these oocytes come from an ovary in contact with an endometrioma.
Read the detailed description
There is no consensus for whether an endometrioma influences oocyte quality, as well as the possible mechanisms that induce them.
In this study, the oocyte maturation will proof oocyte quality: This mean, the percentage of oocytes in metaphase II obtained after stimulation, as well as the rate of oocytes fertilized in direct contact with an endometrioma.
- Conditions
- Endometriosis
- Being tested
- Collect retrospectively data
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect retrospectively dataOther
Collect retrospectively data
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | No drugs are administered. It is an observational study. Collect retrospectively data Receives: Other: Collect retrospectively data | |
| No endometriosis | No drugs are administered. It is an observational study. Collect retrospectively data Receives: Other: Collect retrospectively data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of mature oocytes
Number of MII oocytes from the total of cumulus granulosa cell-oocyte complex by 100
Measured: Up to 36 months
Fertilization rate
Number of oocytes with pronuclear activation after ICSI procedure from the total oocytes microinjected by 100
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study startJan 2017
- Primary completionNov 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elkin Muñoz, Principal Investigator, Principal investigator, IVI Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352661
- Sponsor's protocol ID
- 1311-VGO-137-EM
- Acronym
- ENDOVOC
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Garcia-Velasco JA, Mahutte NG, Corona J, Zuniga V, Giles J, Arici A, Pellicer A. Removal of endometriomas before in vitro fertilization does not improve fertility outcomes: a matched, case-control study. Fertil Steril. 2004 May;81(5):1194-7. doi: 10.1016/j.fertnstert.2003.04.006.
PubMed 15136074Garrido N, Navarro J, Remohi J, Simon C, Pellicer A. Follicular hormonal environment and embryo quality in women with endometriosis. Hum Reprod Update. 2000 Jan-Feb;6(1):67-74. doi: 10.1093/humupd/6.1.67.
PubMed 10711831Filippi F, Benaglia L, Paffoni A, Restelli L, Vercellini P, Somigliana E, Fedele L. Ovarian endometriomas and oocyte quality: insights from in vitro fertilization cycles. Fertil Steril. 2014 Apr;101(4):988-93.e1. doi: 10.1016/j.fertnstert.2014.01.008. Epub 2014 Mar 3.
PubMed 24602751
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of an Endometrioma on Oocyte Quality
- ClinicalTrials.gov ID
- NCT03352661
- Acronym / sponsor ID
- ENDOVOC / 1311-VGO-137-EM
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IVI VigoUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 24 Nov 2017 (actual)
- 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 purpose of this study is to evaluate if there are differences in oocyte quality depending on whether these oocytes come from an ovary in contact with an endometrioma.
Detailed description
There is no consensus for whether an endometrioma influences oocyte quality, as well as the possible mechanisms that induce them.
In this study, the oocyte maturation will proof oocyte quality: This mean, the percentage of oocytes in metaphase II obtained after stimulation, as well as the rate of oocytes fertilized in direct contact with an endometrioma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | – | Other: Collect retrospectively dataNo drugs are administered. It is an observational study. Collect retrospectively data |
| No endometriosis | – | Other: Collect retrospectively dataNo drugs are administered. It is an observational study. Collect retrospectively data |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients <40 years, BMI <30kg / m2,
Key inclusion criteria (1 listed)
- Patients <40 years, BMI <30kg / m2,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Collect retrospectively dataCollect retrospectively data | Other | Endometriosis, No endometriosis |
Primary outcome
Percentage of mature oocytes
Time frame: Up to 36 months
Number of MII oocytes from the total of cumulus granulosa cell-oocyte complex by 100
Fertilization rate
Time frame: Up to 36 months
Number of oocytes with pronuclear activation after ICSI procedure from the total oocytes microinjected by 100
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Background: PubMed 15136074Garcia-Velasco JA, Mahutte NG, Corona J, Zuniga V, Giles J, Arici A, Pellicer A. Removal of endometriomas before in vitro fertilization does not improve fertility outcomes: a matched, case-control study. Fertil Steril. 2004 May;81(5):1194-7. doi: 10.1016/j.fertnstert.2003.04.006.
- Background: PubMed 10711831Garrido N, Navarro J, Remohi J, Simon C, Pellicer A. Follicular hormonal environment and embryo quality in women with endometriosis. Hum Reprod Update. 2000 Jan-Feb;6(1):67-74. doi: 10.1093/humupd/6.1.67.
- Background: PubMed 24602751Filippi F, Benaglia L, Paffoni A, Restelli L, Vercellini P, Somigliana E, Fedele L. Ovarian endometriomas and oocyte quality: insights from in vitro fertilization cycles. Fertil Steril. 2014 Apr;101(4):988-93.e1. doi: 10.1016/j.fertnstert.2014.01.008. Epub 2014 Mar 3.
- Individual participant dataSharing planned: No
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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.
Elkin Muñoz, Principal Investigator principal investigator
IVI Vigo
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by IVI Vigo.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Percentage of mature oocytes (time frame: Up to 36 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?
On the ClinicalTrials.gov record for NCT03352661, which also lists 3 linked publications.
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 24 Nov 2017.