Influence of an Endometrioma on Oocyte Quality (ENDOVOC)
November 20, 2017 updated by: IVI Vigo
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
80
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Patients <40 years, BMI <30kg / m2,
Description
Inclusion Criteria:
- Patients <40 years, BMI <30kg / m2,
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Endometriosis
No drugs are administered.
It is an observational study.
Collect retrospectively data
|
Collect retrospectively data
|
|
No endometriosis
No drugs are administered.
It is an observational study.
Collect retrospectively data
|
Collect retrospectively data
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Up to 36 months
|
|
Fertilization rate
Time Frame: Up to 36 months
|
Number of oocytes with pronuclear activation after ICSI procedure from the total oocytes microinjected by 100
|
Up to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elkin Muñoz, Principal Investigator, IVI Vigo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Garrido 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.
- 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.
- Filippi 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (Anticipated)
November 1, 2017
Study Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
January 17, 2017
First Submitted That Met QC Criteria
November 20, 2017
First Posted (Actual)
November 24, 2017
Study Record Updates
Last Update Posted (Actual)
November 24, 2017
Last Update Submitted That Met QC Criteria
November 20, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1311-VGO-137-EM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.