Mullerian Anomaly of Uterus, NecCONUTA&PPCOSNCT04776915
Congenital Uterine Anomalies & Pregnancy in Polycystic Ovarian Syndrome
An observational study of Mullerian Anomaly of Uterus, Nec, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Prospective research in which patients who applied to UUTF Gynecology and Obstetrics ART center for the treatment of infertility (inability to conceive despite one year of unprotected sexual intercourse), who will undergo IVF due to PCOS and unexplained infertility Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Mullerian Anomaly of Uterus, Nec
- What is being tested?
- Ultrasound and Hysterosalpingography
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2020to 1 Feb 2022
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile Patients who undergo IVF\&ICSI treatment
Who may be able to join
- Being in the age range of 20-40
- Need for an assisted reproductive method due to PCOS or unexplained infertility
Who cannot join
- <20 years or >40 years
- Detecting a cause for infertility other than PCOS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uludag University ART Center
Bursa
Gürkan Uncu, Prof., 02242952541, guncu@gurkanuncu.org
About this study
Official title: Investigation of the Effect of Serum Androgen and Anti-Mullerian Hormone Levels on the Frequency of Müllerian Anomalies and Pregnancy Outcomes in Patients With Polycystic Ovarian Syndrome Undergoing Invitro Fertilization
Prospective research in which patients who applied to UUTF Gynecology and Obstetrics ART center for the treatment of infertility (inability to conceive despite one year of unprotected sexual intercourse), who will undergo IVF due to PCOS and unexplained infertility
Read the detailed description
As of 01/10/2020, IVF cycles of patients with PCOS (n = 105) and unexplained infertility (n = 105) who have applied to Bursa Uludag University Gynecology and Obstetrics Department, Reproductive Treatments Center, will be included in the study. Demographic data of all patients (age, BMI, smoking), presence of hyperandrogenism findings such as systemic diseases, hirsutism, alopecia, FSH, LH, LH/FSH ratio, estradiol levels, pregestational serum AMH levels, uterine anomalies detected by transvaginal USG or hysterosalpingography, controlled ovarian hyperstimulation protocols and doses; Besides, DHEA-S, Free Testosterone, 17-OH Progesterone levels will be recorded in patients diagnosed with PCOS. All these data are routine laboratory and imaging parameters of patients who underwent in vitro fertilization in our UYTE center. Pregnancy results of the patients (biochemical pregnancy, anembryonic pregnancy, abortion, clinical pregnancy, live birth), perinatal results and complications during clinical pregnancy, delivery ways, and newborn APGAR scores will be recorded. Results will be compared with patients in the control group diagnosed with unexplained infertility.
- Conditions
- Mullerian Anomaly of Uterus, Nec
- Being tested
- Ultrasound and Hysterosalpingography
- Keywords
- mullerian anomaly, PCOS, antimullerian hormone
- Medical subject headings
- Enterocolitis, Necrotizing, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and HysterosalpingographyDiagnostic test
Ultrasound and Hysterosalpingography
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Infertile patients due to polycystic ovarian syndrome Receives: Diagnostic Test: Ultrasound and Hysterosalpingography | |
| Control Group | Infertile patients due to unexplained infertility Receives: Diagnostic Test: Ultrasound and Hysterosalpingography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of Mullerian Abnormality
ESHRE\&ESGE uterine abnormality classification
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start14 Oct 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mullerian Anomaly of Uterus, NecStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜRKAN UNCU,PROF. MD, Uludag University
- Investigators
- Özge Albayrak, M.D, Principal investigator, Bursa Uludag University School of Medicine ART Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776915
- Sponsor's protocol ID
- 2020-18/17
- Acronym
- CONUTA&PPCOS
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Serum Androgen and Anti-Mullerian Hormone Levels on the Frequency of Müllerian Anomalies and Pregnancy Outcomes in Patients With Polycystic Ovarian Syndrome Undergoing Invitro Fertilization
- ClinicalTrials.gov ID
- NCT04776915
- Acronym / sponsor ID
- CONUTA&PPCOS / 2020-18/17
- Conditions
- Mullerian Anomaly of Uterus, Nec
- Keywords
- mullerian anomaly, PCOS, antimullerian hormone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 2 Mar 2021 (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.
Prospective research in which patients who applied to UUTF Gynecology and Obstetrics ART center for the treatment of infertility (inability to conceive despite one year of unprotected sexual intercourse), who will undergo IVF due to PCOS and unexplained infertility
Detailed description
As of 01/10/2020, IVF cycles of patients with PCOS (n = 105) and unexplained infertility (n = 105) who have applied to Bursa Uludag University Gynecology and Obstetrics Department, Reproductive Treatments Center, will be included in the study. Demographic data of all patients (age, BMI, smoking), presence of hyperandrogenism findings such as systemic diseases, hirsutism, alopecia, FSH, LH, LH/FSH ratio, estradiol levels, pregestational serum AMH levels, uterine anomalies detected by transvaginal USG or hysterosalpingography, controlled ovarian hyperstimulation protocols and doses; Besides, DHEA-S, Free Testosterone, 17-OH Progesterone levels will be recorded in patients diagnosed with PCOS. All these data are routine laboratory and imaging parameters of patients who underwent in vitro fertilization in our UYTE center. Pregnancy results of the patients (biochemical pregnancy, anembryonic pregnancy, abortion, clinical pregnancy, live birth), perinatal results and complications during clinical pregnancy, delivery ways, and newborn APGAR scores will be recorded. Results will be compared with patients in the control group diagnosed with unexplained infertility.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Ultrasound and HysterosalpingographyInfertile patients due to polycystic ovarian syndrome |
| Control Group | – | Diagnostic Test: Ultrasound and HysterosalpingographyInfertile patients due to unexplained infertility |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile Patients who undergo IVF\&ICSI treatment
Key inclusion criteria (2 listed)
- Being in the age range of 20-40
- Need for an assisted reproductive method due to PCOS or unexplained infertility
Key exclusion criteria (2 listed)
- <20 years or >40 years
- Detecting a cause for infertility other than PCOS
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 |
|---|---|---|
| Ultrasound and HysterosalpingographyUltrasound and Hysterosalpingography | Diagnostic test | Control Group, Study Group |
Primary outcome
The rate of Mullerian Abnormality
Time frame: One year
ESHRE\&ESGE uterine abnormality classification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Mullerian Anomaly of Uterus, Nec
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RecruitingObservational study
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies (MULAN)
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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.
Özge Albayrak, M.D principal investigator
Bursa Uludag University School of Medicine ART Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mullerian Anomaly of Uterus, Nec, run by Uludag University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gürkan Uncu, Prof. (+902242952541, guncu@gurkanuncu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of Mullerian Abnormality (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2021.