Ovarian Function InsufficiencyNCT01782807
Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy
A study testing Salpingectomy or Fimbriectomy in people with Ovarian Function Insufficiency, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
The impact of Hysterectomy with preservation of the ovaries on ovarian function has long been controversial. studies have shown conflicting data regarding ovarian function after simple Hysterectomy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Function Insufficiency
- What is being tested?
- Salpingectomy or Fimbriectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Jun 2014
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women undergoing Hysterectomy for Benign In dication (eg. Uterus Myomatous) before menopause
Who cannot join
- Menopause
- known or suspected malignancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Kaplan Medical Center
Rehovot
Alon Ben- Arie, MD, abenarie@hotmail.com
Yael Naaman, MD, yaelnaa@gmail.com
About this study
The impact of Hysterectomy with preservation of the ovaries on ovarian function has long been controversial. studies have shown conflicting data regarding ovarian function after simple Hysterectomy.
In recent years, there is a growing evidence that Salpingectomy or Fimbriectomy may have preventive value reducing Ovarian and Primary Peritoneal carcinoma, but the safety and the consequences regarding ovarian function have yet to be established.
The aim of this study is to evaluate ovarian function after Hysterectomy alone Vs. Hysterectomy combined with salpingectomy or fimbriectomy
- Conditions
- Ovarian Function Insufficiency
- Being tested
- Salpingectomy or Fimbriectomy
- Keywords
- Ovarian function, Hysterectomy, Salpingectomy, Anti mullerian hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salpingectomy or FimbriectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hysterectomy | No intervention | Hysterectomy without oophorectomy or salpingectomy |
| Hysterctomy with salpingectomy or fimbriectomy | Experimental | Salpingectomy or Fimbriectomy Receives: Procedure: Salpingectomy or Fimbriectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian function
ovarian function measured by FSH , AMH and follicule count on ultra-sound
Measured: 60 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startOct 2011
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ovarian Function InsufficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lion Poles, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782807
- Sponsor's protocol ID
- kmc0029-11
- Status last verified
- Jun 2011
- First submitted
- 31 Jan 2013
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Maseela T, Scheele R. [Hysterosalpingectomy. A contribution to the prevention of primary tubal neoplasms]. Fortschr Med. 1980 Jun 5;98(21):818-22. German.
PubMed 7409710Zalel Y, Lurie S, Beyth Y, Goldberger S, Tepper R. Is it necessary to perform a prophylactic oophorectomy during hysterectomy? Eur J Obstet Gynecol Reprod Biol. 1997 May;73(1):67-70. doi: 10.1016/s0301-2115(97)02702-4.
PubMed 9175692Morse AN, Hammer RA, Walter AJ, Baker S, Magtibay PM. Does hysterectomy without adnexectomy in patients with prior tubal interruption increase the risk of subsequent hydrosalpinx? Am J Obstet Gynecol. 2002 Dec;187(6):1483-5; discussion 1485-6. doi: 10.1067/mob.2002.130212.
PubMed 12501050Farquhar CM, Sadler L, Harvey SA, Stewart AW. The association of hysterectomy and menopause: a prospective cohort study. BJOG. 2005 Jul;112(7):956-62. doi: 10.1111/j.1471-0528.2005.00696.x.
PubMed 15957999Riedel HH, Lehmann-Willenbrock E, Semm K. Ovarian failure phenomena after hysterectomy. J Reprod Med. 1986 Jul;31(7):597-600.
PubMed 3746790Bulent Tiras M, Noyan V, Ozdemir H, Guner H, Yildiz A, Yildirim M. The changes in ovarian hormone levels and ovarian artery blood flow rate after laparoscopic tubal sterilization. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 1;99(2):219-21. doi: 10.1016/s0301-2115(01)00410-9.
PubMed 11788175
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy
- ClinicalTrials.gov ID
- NCT01782807
- Acronym / sponsor ID
- kmc0029-11
- Conditions
- Ovarian Function Insufficiency
- Keywords
- Ovarian function, Hysterectomy, Salpingectomy, Anti mullerian hormone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2014 (estimated)
- First posted
- 4 Feb 2013 (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.
The impact of Hysterectomy with preservation of the ovaries on ovarian function has long been controversial. studies have shown conflicting data regarding ovarian function after simple Hysterectomy.
In recent years, there is a growing evidence that Salpingectomy or Fimbriectomy may have preventive value reducing Ovarian and Primary Peritoneal carcinoma, but the safety and the consequences regarding ovarian function have yet to be established.
The aim of this study is to evaluate ovarian function after Hysterectomy alone Vs. Hysterectomy combined with salpingectomy or fimbriectomy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysterectomy | No intervention | –Hysterectomy without oophorectomy or salpingectomy |
| Hysterctomy with salpingectomy or fimbriectomy | Experimental | Procedure: Salpingectomy or FimbriectomySalpingectomy or Fimbriectomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing Hysterectomy for Benign In dication (eg. Uterus Myomatous) before menopause
Key exclusion criteria (2 listed)
- Menopause
- known or suspected malignancy
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 |
|---|---|---|
| Salpingectomy or Fimbriectomy | Procedure or surgery | Hysterctomy with salpingectomy or fimbriectomy |
Primary outcome
Ovarian function
Time frame: 60 days post-operative
ovarian function measured by FSH , AMH and follicule count on ultra-sound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Background: PubMed 7409710Maseela T, Scheele R. [Hysterosalpingectomy. A contribution to the prevention of primary tubal neoplasms]. Fortschr Med. 1980 Jun 5;98(21):818-22. German.
- Background: PubMed 9175692Zalel Y, Lurie S, Beyth Y, Goldberger S, Tepper R. Is it necessary to perform a prophylactic oophorectomy during hysterectomy? Eur J Obstet Gynecol Reprod Biol. 1997 May;73(1):67-70. doi: 10.1016/s0301-2115(97)02702-4.
- Background: PubMed 12501050Morse AN, Hammer RA, Walter AJ, Baker S, Magtibay PM. Does hysterectomy without adnexectomy in patients with prior tubal interruption increase the risk of subsequent hydrosalpinx? Am J Obstet Gynecol. 2002 Dec;187(6):1483-5; discussion 1485-6. doi: 10.1067/mob.2002.130212.
- Background: PubMed 15957999Farquhar CM, Sadler L, Harvey SA, Stewart AW. The association of hysterectomy and menopause: a prospective cohort study. BJOG. 2005 Jul;112(7):956-62. doi: 10.1111/j.1471-0528.2005.00696.x.
- Background: PubMed 3746790Riedel HH, Lehmann-Willenbrock E, Semm K. Ovarian failure phenomena after hysterectomy. J Reprod Med. 1986 Jul;31(7):597-600.
- Background: PubMed 11788175Bulent Tiras M, Noyan V, Ozdemir H, Guner H, Yildiz A, Yildirim M. The changes in ovarian hormone levels and ovarian artery blood flow rate after laparoscopic tubal sterilization. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 1;99(2):219-21. doi: 10.1016/s0301-2115(01)00410-9.
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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 Salpingectomy or Fimbriectomy in people with Ovarian Function Insufficiency, run by Kaplan Medical Center at 1 site in Israel.
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 1 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 4 Feb 2013. 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 Israel. 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 Alon Ben- Arie, MD (00-972-50-2460001, abenarie@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian function (time frame: 60 days post-operative). 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 NCT01782807, which also lists 6 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 4 Feb 2013.