Uterine Artery LigationNCT03896243
Serum Antimullerian Hormone Levels in Patients Who Underwent Uterine Artery Ligation
An observational study of Uterine Artery Ligation and Ovarian Reserve, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators would like to see the amh values after uterine artery ligation Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Artery Ligation, Ovarian Reserve
- What is being tested?
- Uterine artery ligation (UAL)
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Feb 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients who had uterine artery ligation during C-section. Control group is age-matched postpartum patients.
Who may be able to join
- age 18- 35 years
- no systemic or endocrine diseases
- patients who had uterine artery ligation due to atony
- healthy postpartum patients as controls
Who cannot join
- patients with PCOS
- Pregnancy with IVF or oosit donation
- Patients with endocrinopathy, diseases which require radiotherapy and chemotherapy etc.
- Patients with BMI >40
Trial locations and contacts
1 site in 1 country.
About this study
Investigators would like to see the amh values after uterine artery ligation
Read the detailed description
Group/cohort:
Uterine artery ligation (UAL) Investigators would like to invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section.
Participants would be evaluated for their ovarian reserve via hormones and antral follicle count (AFC)
Control Group:
Investigators would like to invite the patients to the hospital at least 6 months after C-section who delivered baby without any complication.
Participants would be also evaluated for their ovarian reserve via hormones and antral follicle count (AFC)
- Conditions
- Uterine Artery Ligation, Ovarian Reserve
- Being tested
- Uterine artery ligation (UAL)
- Keywords
- Uterine atony, amh
- Medical subject headings
- Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine artery ligation (UAL)Diagnostic test
Uterine artery ligation (UAL) We will invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section.
They will evaluated for their ovarian reserve via hormones and antral follicle count (AFC)
| Study group | Role | What they receive |
|---|---|---|
| Uterine artery ligation (UAL) | We would like toinvite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section.
They would be evaluated for their ovarian reserve via hormones and antral follicle count (AFC) Receives: Diagnostic Test: Uterine artery ligation (UAL) | |
| Control Group: | We would like to invite the patients to the hospital at least 6 months after C-section who delivered baby without any complication.
They would be also evaluated for their ovarian reserve via hormones and antral follicle count (AFC) Receives: Diagnostic Test: Uterine artery ligation (UAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.ovarian reserve in patients with uterine artery ligation
calculation of ovarian reserve with amh (ng/ml) after uterine artery ligation due to uterine atony
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Artery LigationStudies 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
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896243
- Sponsor's protocol ID
- uterinarter
- Status last verified
- Mar 2019
- First submitted
- 27 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Antimullerian Hormone Levels in Patients Who Underwent Uterine Artery Ligation
- ClinicalTrials.gov ID
- NCT03896243
- Acronym / sponsor ID
- uterinarter
- Conditions
- Uterine Artery Ligation, Ovarian Reserve
- Keywords
- Uterine atony, amh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 29 Mar 2019 (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.
Investigators would like to see the amh values after uterine artery ligation
Detailed description
Group/cohort:
Uterine artery ligation (UAL) Investigators would like to invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section.
Participants would be evaluated for their ovarian reserve via hormones and antral follicle count (AFC)
Control Group:
Investigators would like to invite the patients to the hospital at least 6 months after C-section who delivered baby without any complication.
Participants would be also evaluated for their ovarian reserve via hormones and antral follicle count (AFC)
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uterine artery ligation (UAL) | – | Diagnostic Test: Uterine artery ligation (UAL)We would like toinvite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section. They would be evaluated for their ovarian reserve via hormones and antral follicle count (AFC) |
| Control Group: | – | Diagnostic Test: Uterine artery ligation (UAL)We would like to invite the patients to the hospital at least 6 months after C-section who delivered baby without any complication. They would be also evaluated for their ovarian reserve via hormones and antral follicle count (AFC) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who had uterine artery ligation during C-section. Control group is age-matched postpartum patients.
Key inclusion criteria (4 listed)
- age 18- 35 years
- no systemic or endocrine diseases
- patients who had uterine artery ligation due to atony
- healthy postpartum patients as controls
Key exclusion criteria (4 listed)
- patients with 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 |
|---|---|---|
| Uterine artery ligation (UAL)Uterine artery ligation (UAL) We will invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section. They will evaluated for their ovarian reserve via hormones and antral follicle count (AFC) | Diagnostic test | Control Group:, Uterine artery ligation (UAL) |
Primary outcome
1.ovarian reserve in patients with uterine artery ligation
Time frame: 12 months
calculation of ovarian reserve with amh (ng/ml) after uterine artery ligation due to uterine atony
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 29 Mar 2019.
- Individual participant dataSharing planned: Yes
Related trials for Uterine Artery Ligation
Recruiting
Reducing Blood Loss During Myomectomy:Uterine Artery Ligation Vs Pericervical Tourniquet
Myoma;Uterus, Blood Loss
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Uterine Artery Ligation and Ovarian Reserve, run by Kanuni Sultan Suleyman Training and Research Hospital 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 4 inclusion and 4 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 29 Mar 2019. 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?
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?
1.ovarian reserve in patients with uterine artery ligation (time frame: 12 months). 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 29 Mar 2019.