ClinicalTrials.gg
Status unknownNCT03352661ENDOVOCUpdated Nov 24, 2017

Influence of an Endometrioma on Oocyte Quality

An observational study in Endometriosis, sponsored by IVI Vigo. Status unknown. Open to female participants aged 25 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-11-24.

Sponsored by IVI Vigo · Observational

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
25 Years to 40 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Endometriosis

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In context

Endometriosis

921 studies on the registry are indexed under Endometriosis; 267 are open to participants now.

This study's enrollment of 80 is below the median of 135 across 349 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

IVI Vigo is the lead sponsor of 9 studies on the registry; none are open to participants now.

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

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Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients \<40 years, BMI \<30kg / m2,

Inclusion criteria

  • Patients \<40 years, \<30kg / m2,

Exclusion criteria

Exclusion Criteria:

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Endometriosis

    No drugs are administered. It is an observational study. Collect retrospectively data

    Other: Collect retrospectively data

  • No endometriosis

    No drugs are administered. It is an observational study. Collect retrospectively data

    Other: Collect retrospectively data

Interventions

  • OtherCollect retrospectively data

    Collect retrospectively data

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What researchers measure

Primary outcomes

  1. Percentage of mature oocytes

    Number of MII oocytes from the total of cumulus granulosa cell-oocyte complex by 100

    Time frame: Up to 36 months

  2. Fertilization rate

    Number of oocytes with pronuclear activation after ICSI procedure from the total oocytes microinjected by 100

    Time frame: Up to 36 months

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Study locations

No study locations are listed for this record.

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References and documents

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 15136074 ↗
  • 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. PubMed 10711831 ↗
  • 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. PubMed 24602751 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2017, a primary completion of Nov 2017 and a completion of Jan 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2017
First posted
Nov 24, 2017
Start
Jan 2017
Primary completionEst.
Nov 2017
CompletionEst.
Jan 2018
Last update
Nov 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03352661
Lead sponsor
IVI Vigo
Responsible party
Sponsor
First posted
Nov 24, 2017
Start date
Jan 2017
Primary completion
Nov 2017 (estimated)
Completion
Jan 2018 (estimated)
Last update
Nov 24, 2017

Study contacts

Elkin Muñoz, Principal Investigator
principal investigator · IVI Vigo

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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