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Do müllerian Anomalies Affect Embryo Implantation?

Do müllerian Anomalies Affect Embryo Implantation?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04571671
Acronym
AM
Enrollment
5000
Registered
2020-10-01
Start date
2014-01-20
Completion date
2019-07-25
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Diseases

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.

Detailed description

The main reproductive problems associated with these malformations include, abortion , recurrent abortion ectopic pregnancy and preterm delivery . The experience gained from oocyte donation shows that these women are pregnant less, even with the transfer of good quality embryos. The hypothesis of this poor uterine receptivity is in the poor endometrial vascularization that can decrease embryo implantation. The reason for infertility in women with AM includes decreased muscle mass, decreased endometrial vascularization, decreased capacity of the endometrial cavity, less receptive areas (septum). The lower fertility observed in some women with Müllerian malformations has been partially explained by its tubal factor and its association with endometriosis, with a higher prevalence in them, compared to patients without malformations. Studies have confirmed an irregular differentiation and estrogenic maturation of the endometrium lining the uterine septum or its internal structure, which has less presence of connective tissue and more muscle mass. Given the confusion generated if the unfavorable reproductive result is due to oocyte quality or endometrial receptivity, it is necessary to use a model that guarantees oocyte / embryo quality and this is offered by oocyte donation. The aim is to evaluate the implantation rate in women with MA who receive donated oocytes compared to women without MA.

Interventions

Analyse the incidence of Mullerian anomalies in these populations

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA
CollaboratorOTHER
IVI Vigo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 50 Years

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
embryo implantation rateSince 2000 to april 2019To compare embryo implantation rate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026