Ovarian ReserveNCT02995343
Evaluation of the Ovarian Reserve in Patients Who Hypogastric Arteries and or Uterine Arteries Had Been Ligated
A study testing Hypogastric and/or uterine artery ligation in people with Ovarian Reserve and Hypogastric Artery Ligation, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes, antral follicule count, follicule stimuli hormone and estrogen levels. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Reserve, Hypogastric Artery Ligation, Uterine Artery Ligation
- What is being tested?
- Hypogastric and/or uterine artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2016to Sep 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients had been ligated hypogastric and/or uterine arteries
- Patients are in 6 month period after surgery
- Without performed hysterectomy
- No older than 40 years old
- No history about endocrinopathy which have an effect upon ovarian reserve
Who cannot join
- Patients had been made other gynecologic surgery such as fallopian tube ligation and hysterectomy etc.
- Patients are older than 40 years old
- Patients use drugs which have an effect upon ovarian reserve
- Patients have diseases which have an effect upon ovarian reserve such as some endocrinopathy, malign diseases which require radiotherapy and chemotherapy etc.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University, Medicine Faculty, Department of Obstetrics and Gynecology
Izmir, 35100
cagdas sahin, MD, +905324676106, cagdasdr@yahoo.com
About this study
Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes, antral follicule count, follicule stimuli hormone and estrogen levels. Investigators will search their archives for finding suitable patients for study. Investigators will especially notice being at least 6 month time of interval between surgery and evaluation time. Ultrasound examination and taking blood sample will be performed on 2nd or 3th day of menstrual cycle. These results will be compared with normal postpartum women's results. It will be evaluated that there is or not any effect of the hypogastric arteries and/or uterine arteries on ovarian reserve
- Being tested
- Hypogastric and/or uterine artery ligation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypogastric and/or uterine artery ligationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hypogastric and/or uterine artery ligation | Experimental | Patients who had been ligated hypogastric artery and or uterine artery for ceasing uterine bleeding during c-section Receives: Procedure: Hypogastric and/or uterine artery ligation |
| Normal postpartum women | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-mullerian hormone levels will be evaluated
Measured: 6 months after surgery and delivery
Antral Follicule Count will be evaluated
Measured: 6 months after surgery and delivery
Ovarian volume will be evaluated
Measured: 6 months after surgery and delivery
Follicule Stimuli Hormone levels will be evaluated
Measured: 6 months after surgery and delivery
Estrogen levels will be evaluated
Measured: 6 months after surgery and delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagdas Sahin, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995343
- Sponsor's protocol ID
- 2.100.2014.0076
- Status last verified
- Mar 2019
- First submitted
- 12 Dec 2016
- Last updated
- 28 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ovarian Reserve in Patients Who Hypogastric Arteries and or Uterine Arteries Had Been Ligated
- ClinicalTrials.gov ID
- NCT02995343
- Acronym / sponsor ID
- 2.100.2014.0076
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 16 Dec 2016 (estimated)
- 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.
Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes, antral follicule count, follicule stimuli hormone and estrogen levels. Investigators will search their archives for finding suitable patients for study. Investigators will especially notice being at least 6 month time of interval between surgery and evaluation time. Ultrasound examination and taking blood sample will be performed on 2nd or 3th day of menstrual cycle. These results will be compared with normal postpartum women's results. It will be evaluated that there is or not any effect of the hypogastric arteries and/or uterine arteries on ovarian reserve
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypogastric and/or uterine artery ligation | Experimental | Procedure: Hypogastric and/or uterine artery ligationPatients who had been ligated hypogastric artery and or uterine artery for ceasing uterine bleeding during c-section |
| Normal postpartum women | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients had been ligated hypogastric and/or uterine arteries
- Patients are in 6 month period after surgery
- Without performed hysterectomy
- No older than 40 years old
- No history about endocrinopathy which have an effect upon ovarian reserve
Key exclusion criteria (4 listed)
- Patients had been made other gynecologic surgery such as fallopian tube ligation and hysterectomy etc.
- Patients are older than 40 years old
- Patients use drugs which have an effect upon ovarian reserve
- Patients have diseases which have an effect upon ovarian reserve such as some endocrinopathy, malign diseases which require radiotherapy and chemotherapy etc.
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 and/or uterine artery ligation | Procedure or surgery | Hypogastric and/or uterine artery ligation |
Primary outcome
Anti-mullerian hormone levels will be evaluated
Time frame: 6 months after surgery and delivery
Antral Follicule Count will be evaluated
Time frame: 6 months after surgery and delivery
Ovarian volume will be evaluated
Time frame: 6 months after surgery and delivery
Follicule Stimuli Hormone levels will be evaluated
Time frame: 6 months after surgery and delivery
Estrogen levels will be evaluated
Time frame: 6 months after surgery and delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypogastric and/or uterine artery ligation in people with Ovarian Reserve and Hypogastric Artery Ligation, run by Ege 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 5 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: status not confirmed, as of the sponsor's last update on 28 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cagdas sahin, MD (+905324676106, cagdasdr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-mullerian hormone levels will be evaluated (time frame: 6 months after surgery and delivery). The study lists 5 primary outcomes in all. 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 28 Mar 2019.