Uterine DiseasesAMNCT04571671
Do müllerian Anomalies Affect Embryo Implantation?
An observational study of Uterine Diseases, run by IVI Vigo.
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. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Uterine Diseases
- What is being tested?
- Collect retrospectively data
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2014to 25 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Uterine Diseases
- Being tested
- Collect retrospectively data
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect retrospectively dataOther
Analyse the incidence of Mullerian anomalies in these populations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Collect retrospectively data |
What is being measured
The primary outcome is the main question the study is designed to answer.
embryo implantation rate
To compare embryo implantation rate
Measured: Since 2000 to april 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start20 Jan 2014
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uterine DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Responsible party
- Sponsor
- Investigators
- Ekin DR Muñoz, MD, Principal investigator, IVI VigoAgustina Ramos Gutierrez, Study chair, IVI Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571671
- Sponsor's protocol ID
- 1405-VIG-029-EM
- Acronym
- AM
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1355763Munoz 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.
PubMed 37392783
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do müllerian Anomalies Affect Embryo Implantation?
- ClinicalTrials.gov ID
- NCT04571671
- Acronym / sponsor ID
- AM / 1405-VIG-029-EM
- Conditions
- Uterine Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- IVI VigoUniversity, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Study start
- 20 Jan 2014 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Collect retrospectively dataWomen 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. |
| Control group | – | Other: Collect retrospectively dataPatients 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 |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect retrospectively dataAnalyse the incidence of Mullerian anomalies in these populations | Other | Control group, Study group |
Primary outcome
embryo implantation rate
Time frame: Since 2000 to april 2019
To compare embryo implantation rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Background: PubMed 1355763Makino 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.
- Derived from this study: PubMed 37392783Munoz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekin DR Muñoz, MD principal investigator
IVI Vigo
Agustina Ramos Gutierrez study chair
IVI Vigo
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Diseases, run by IVI Vigo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
embryo implantation rate (time frame: Since 2000 to april 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571671, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.