Do müllerian Anomalies Affect Embryo Implantation?

Uterine Diseases Clinical Trial

— AM  

Official title:

Do müllerian Anomalies Affect Embryo Implantation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571671
• Other study ID #: 1405-VIG-029-EM
• Status: Completed
• Start date: January 20, 2014
• Est. completion date: July 25, 2019

Study information

• Verified date: September 2020
• Source: IVI Vigo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: July 25, 2019
• Est. primary completion date: July 25, 2019
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Uterine Diseases

Intervention

Other:
• Collect retrospectively data
Analyse the incidence of Mullerian anomalies in these populations

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
IVI Vigo	Instituto Valenciano de Infertilidad, IVI VALENCIA

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	embryo implantation rate	To compare embryo implantation rate	Since 2000 to april 2019