AMHNCT03220594
Serum AMH Levels in Patients Who Underwent Hypogastric Artery Ligation
An observational study of AMH, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To observe the effects of hypogastric artery ligation on serum antimullerian hormone levels. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- AMH
- What is being tested?
- hypogastric artery ligation
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2017to 29 Sep 2017
- How long will I take part?
- 6 Months
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients who had hypogastric artery ligation and/or hysterectomy during their delivery. Control group is age-matched postpartum patients.
Who may be able to join
- age 18- 40 years
- no systemic or endocrine diseases
- patients who had hypogastric artery ligation and/or hysterectomy
- healthy postpartum patients as controls
Who cannot join
- history of chemotherapy and/or radiotherapy
- Obese patients
- patients with previous/present endometriosis
- patients with PCOS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Antimullerian Hormone Levels in Patients Who Underwent Hypogastric Artery Ligation
To observe the effects of hypogastric artery ligation on serum antimullerian hormone levels.
Read the detailed description
To measure and compare serum antimullerian hormone levels in patients who underwent hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy and postpartum control. The procedures performed as an emergency life saving method during delivery. The reasons for hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy were obstetric hemorrhage mainly uterine atony.
The serum levels of antimullerian hormone were measured 6 months after the operations and compared with matching postpartum controls. Serum levels of FSH, LH, PRL and TSH were also measured 6 months after the operation. Further, antral follicle count measured along with the aforementioned blood tests.
- Conditions
- AMH
- Being tested
- hypogastric artery ligation
- Keywords
- hypogastric artery, anti-mullerian hormone, ovarian reserve, postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypogastric artery ligationProcedure or surgery
Also called hysterectomy
hypogastric artery ligation is the ligation of the internal iliac artery to stop bleeding related to obstetrics obstetric hemorrhage Hysterectomy is the removal of the uterus if bleeding can't stop by hypogastric artery ligation
| Study group | Role | What they receive |
|---|---|---|
| Hypogastric artery ligation (HAL) | Patients who underwent only hypogastric artery ligation performed during the delivery of their babies. Six months after the operation they will evaluated for their ovarian reserve via hormones and astral follicle count (AFC) Receives: Procedure: hypogastric artery ligation | |
| HAL and hysterectomy | Patients who underwent both hypogastric artery ligation and hysterectomy performed during the delivery of their babies. Six months after the operation they will evaluated for their ovarian reserve via hormones and astral follicle count (AFC) Receives: Procedure: hypogastric artery ligation | |
| Postpartum | Postpartum control group constituted of patients delivered baby without any complication and evaluated 6 months later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve
To evaluate postoperative ovarian reserve using anti-mullerian hormones and other ovary related hormones including FSH,LH
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start20 Mar 2017
- Primary completion20 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMHStudies 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
- 90 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Alev Atıs, MD,ObGyn, Study director, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220594
- Sponsor's protocol ID
- 1826
- Status last verified
- Sep 2017
- First submitted
- 14 Jul 2017
- Last updated
- 2 Oct 2017
- 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 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Antimullerian Hormone Levels in Patients Who Underwent Hypogastric Artery Ligation
- ClinicalTrials.gov ID
- NCT03220594
- Acronym / sponsor ID
- 1826
- Conditions
- AMH
- Keywords
- hypogastric artery, anti-mullerian hormone, ovarian reserve, postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 18 Jul 2017 (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.
To observe the effects of hypogastric artery ligation on serum antimullerian hormone levels.
Detailed description
To measure and compare serum antimullerian hormone levels in patients who underwent hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy and postpartum control. The procedures performed as an emergency life saving method during delivery. The reasons for hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy were obstetric hemorrhage mainly uterine atony.
The serum levels of antimullerian hormone were measured 6 months after the operations and compared with matching postpartum controls. Serum levels of FSH, LH, PRL and TSH were also measured 6 months after the operation. Further, antral follicle count measured along with the aforementioned blood tests.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypogastric artery ligation (HAL) | – | Procedure: hypogastric artery ligationPatients who underwent only hypogastric artery ligation performed during the delivery of their babies. Six months after the operation they will evaluated for their ovarian reserve via hormones and astral follicle count (AFC) |
| HAL and hysterectomy | – | Procedure: hypogastric artery ligationPatients who underwent both hypogastric artery ligation and hysterectomy performed during the delivery of their babies. Six months after the operation they will evaluated for their ovarian reserve via hormones and astral follicle count (AFC) |
| Postpartum | – | –Postpartum control group constituted of patients delivered baby without any complication and evaluated 6 months later. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who had hypogastric artery ligation and/or hysterectomy during their delivery. Control group is age-matched postpartum patients.
Key inclusion criteria (4 listed)
- age 18- 40 years
- no systemic or endocrine diseases
- patients who had hypogastric artery ligation and/or hysterectomy
- healthy postpartum patients as controls
Key exclusion criteria (4 listed)
- history of chemotherapy and/or radiotherapy
- Obese patients
- patients with previous/present endometriosis
- 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 |
|---|---|---|
| hypogastric artery ligationAlso: hysterectomyhypogastric artery ligation is the ligation of the internal iliac artery to stop bleeding related to obstetrics obstetric hemorrhage Hysterectomy is the removal of the uterus if bleeding can't stop by hypogastric artery ligation | Procedure or surgery | HAL and hysterectomy, Hypogastric artery ligation (HAL) |
Primary outcome
Ovarian reserve
Time frame: 6 months
To evaluate postoperative ovarian reserve using anti-mullerian hormones and other ovary related hormones including FSH,LH
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 2 Oct 2017.
- The effect of total abdominal hysterectomy on serum anti-Müllerian hormone levels: a pilot studyLink provided by the sponsor.
- Effect of internal iliac artery ligation on ovarian blood supply and ovarian reserveLink provided by the sponsor.
- 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.
Alev Atıs, MD,ObGyn study director
Kanuni Sultan Suleyman Training and Research Hospital
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 AMH, 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 2 Oct 2017. 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?
Ovarian reserve (time frame: 6 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 2 Oct 2017.