NCT03352661

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 24, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

January 17, 2017

Last Update Submit

November 20, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Percentage of mature oocytes

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

    Up to 36 months

  • Fertilization rate

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

    Up to 36 months

Study Arms (2)

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

Collect retrospectively data

EndometriosisNo endometriosis

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 15136074BACKGROUND
  • 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.

    PMID: 10711831BACKGROUND
  • 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.

    PMID: 24602751BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Elkin Muñoz, Principal Investigator

    IVI Vigo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

November 24, 2017

Study Start

January 1, 2017

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

November 24, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share