NCT04571671

Brief Summary

Müllerian anomalies (MA) are associated with infertility and affect approximately 6.3% of the infertile population. The estimation of the frequency of MAs is not without controversy because it depends on the diagnostic method used and sometimes on the established diagnostic criteria. This pathology is associated with abortion during the second trimester in addition to other complications that include preterm labor, fetal malpositions and an increased rate of caesarean section, although some patients may remain asymptomatic. An association between MA and endometriosis has been described and in particular the case of the septum uterus, therefore it is difficult to establish whether the reproductive results of women with MA tdepend only on the uterine factor or also on the quality of the oocytes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

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 20, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

5.5 years

First QC Date

September 25, 2020

Last Update Submit

October 1, 2020

Conditions

Uterine Diseases

Outcome Measures

Primary Outcomes (1)

  • embryo implantation rate

    To compare embryo implantation rate

    Since 2000 to april 2019

Study Arms (2)

Study group

Women with Müllerian anomalies who have received an oocyte donation. The diagnosis of Müllerian anomalies is established when a cavity is demonstrated uterine abnormality with any of the defects described in the American classifications or European in transvaginal ultrasound, hysteroscopy or hysterosalpingography (HSG). The differential diagnosis in case of doubts is established with 3D ultrasound, MRI or hystero / laparoscopy. All the septa have been resected prior to performing the OVODON cycle.

Other: Collect retrospectively data

Control group

Patients who receive donated oocytes and who do not present Müllerian anomalies. An absence of AM, a transvaginal ultrasound, an HSG or a normal hysteroscopy with a uterine cavity with a normal shape and absence of intracavitary images is considered

Other: Collect retrospectively data

Interventions

Collect retrospectively dataOTHER

Analyse the incidence of Mullerian anomalies in these populations

Control groupStudy group

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with Müllerian anomalies who have received an oocyte donation. The diagnosis of Müllerian anomalies is established when a cavity is demonstrated uterine abnormality with any of the defects described in the American classifications or European in transvaginal ultrasound, hysteroscopy or hysterosalpingography (HSG). The differential diagnosis in case of doubts is established with 3D ultrasound, MRI or hystero / laparoscopy. All the septa have been resected prior to performing the OVODON cycle.

You may qualify if:

  • Women included in the oocyte donation program at IVI Vigo and Valencia 2000-2019.
  • Sperm count greater than 1,000,000 per ml.
  • Transfer on day 5 of embryo development of at least one good quality embryo.

You may not qualify if:

  • Testicular biopsy.
  • Any indication for preimplantation genetic diagnosis or screening.
  • Uterine fibroid greater than 4 cm.
  • Presence of ultrasound or diagnosis by HSG or laparoscopy of hydrosalpinx uni or bilateral.
  • Recurrent abortion.
  • Any abnormality of the uterine cavity other than MA: submucosal myoma, endometrial polyp, or uterine synechiae.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Makino T, Umeuchi M, Nakada K, Nozawa S, Iizuka R. Incidence of congenital uterine anomalies in repeated reproductive wastage and prognosis for pregnancy after metroplasty. Int J Fertil. 1992 May-Jun;37(3):167-70.

    PMID: 1355763BACKGROUND

  • Munoz E, Fernandez I, Pellicer N, Mariani G, Pellicer A, Garrido N. Reproductive outcomes of oocyte donation in patients with uterine Mullerian anomalies. Fertil Steril. 2023 Oct;120(4):850-859. doi: 10.1016/j.fertnstert.2023.06.029. Epub 2023 Jun 29.

    PMID: 37392783DERIVED

MeSH Terms

Conditions

Uterine Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ekin DR Muñoz, MD

    IVI Vigo

    PRINCIPAL INVESTIGATOR

  • Agustina Ramos Gutierrez

    IVI Vigo

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 1, 2020

Study Start

January 20, 2014

Primary Completion

July 25, 2019

Study Completion

July 25, 2019

Last Updated

October 5, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share