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this record recently (last verified Jan 2017), so the status shown — last known as Active, not recruiting — may be out of date.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

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.

Conditions studied

Endometriosis

Browse trials for

Endometriosis 899

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, BMI \<30kg / m2,

Exclusion criteria

Exclusion Criteria:

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

What researchers measure

Primary outcomes

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
Fertilization rate
Number of oocytes with pronuclear activation after ICSI procedure from the total oocytes microinjected by 100
Time frame: Up to 36 months

Study locations

No study locations are listed for this record.

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

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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