Tubal PatencyNCT02146248
HSG and Tubal Patency Study
A study testing combined oral contraceptive and DepoProvera in people with Tubal Patency, run by Jeffrey Jensen at 1 site in United States.
Trial summary
The investigators' research group is working to develop a highly effective, low cost non-surgical method of permanent contraception for women. To support this goal, we need to know more about the normal fallopian tube (tube that passes the egg from the ovary into the womb). 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
- Tubal Patency
- What is being tested?
- combined oral contraceptive and DepoProvera
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Women between 18 and 40 years old ii. In good health, with regular menstrual cycles that occur 24 - 37 days iii. No current use of hormonal contraception or an intrauterine device and having had at least one complete menstrual cycle since having stopped hormonal contraception before starting the treatment.
- Have a negative urine pregnancy test at the admission visit. v. Have a negative chlamydia test at the admission visit. vi. Not be at risk for pregnancy. They will be consistently using a non-hormonal contraception method, have a surgically sterile male partner with a vasectomy, be abstinent, or be in a same-sex relationship from the screening visit through the first study cycle. After starting the combined OC (see Visit 4 below), use of a non-hormonal method is no longer required.
- In the opinion of the investigator, willing and able to follow all study requirements, including use of the approved study medications (doxycycline, oral contraceptive and DMPA).
- Understand and sign an IRB approved inform consent form prior to screening activities.
- Will have diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤145 mm Hg after 5 minutes in sitting position.
- Agree not to participate in any other clinical trials during the course of this study.
Who cannot join
- i. Women with menstrual cycle length of less than 24 or more than 37 days; or with spontaneous irregular menstrual cycle length with intra-individual variations of more than 5 days ii. Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test iii. Women planning pregnancy within their months of study participation iv. Currently breast-feeding or within 30 days of discontinuing breast feeding v. Current use of a hormonal IUD, or other hormonal contraception (including oral contraceptives, contraceptive vaginal rings, contraceptive patches, or contraceptive implants) within 30 days prior to screening. NOTE: Discontinuation of hormonal contraception or removal of implanted hormonal contraceptives must have been for personal reasons unrelated to the purpose of enrollment in this study.
- Undiagnosed abnormal genital bleeding vii. Known hypersensitivity to radio-opaque contrast, doxycycline, levonorgestrel, ethinyl estradiol or depo-medroxyprogesterone acetate. The active ingredients in the approved medications used in the study.
- Anomalies in the clinical exam or history done at screening visit recognized as clinically significant by the investigator.
- Unable to pass a uterine sound at the screening examination. x. A positive test for chlamydia at screening, or a history of a positive test within the last 6 months.
- A clinically significant Pap test abnormality, as managed by current local or national guidelines that would require treatment over the next 6 months.
- Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin cancer) xiii. Body mass index (BMI) >35. xiv. Current use of a non-hormone containing (copper) intrauterine device (IUD). NOTE: Removal of an IUD must have been for personal reasons unrelated to the purpose of enrollment in this study.
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- Smoking if > age 35. xvi. Personal history of venous or arterial thrombosis or embolism, or family history in a first-degree relative <55 years of age suggesting familial defect in blood coagulation system, which in the opinion of the principal investigator, suggests use of a hormonal contraceptive could pose a significant risk.
- Cerebrovascular or cardiovascular disease. xviii. History of retinal vascular lesions, unexplained partial or complete loss of vision.
- Headaches with focal neurological symptoms. xx. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use.
- Use of liver enzyme inducers on a regular basis. xxii. History of involuntary infertility, pelvic inflammatory disease (not followed by a normal pregnancy), or known gynecologic conditions or surgery that could affect tubal patency (e.g. tubal adhesions, endometriosis, hydrosalpinx, salpingectomy, hysterectomy, oophorectomy).
- xxiii. History of a prior HSG showing tubal occlusion on one or both sides.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Tubal Patency During the Menstrual Cycle and During Treatment With Hormonal Contraceptives: a Pilot Study in Women
The investigators' research group is working to develop a highly effective, low cost non-surgical method of permanent contraception for women. To support this goal, we need to know more about the normal fallopian tube (tube that passes the egg from the ovary into the womb). The purpose of this study is to learn about how menstrual cycles and hormonal contraceptives affect tubal patency. Normally there is an opening between the tube and uterus to permit the flow of fluid and cells. If this opening is blocked, this can result in infertility. Tubal patency is when a woman's fallopian tubes are not blocked. Tubal patency is determined by an x-ray test called a hystero-(uterus)salpingo-(fallopian tube)graphy (HSG). HSG is a standard radiological imaging study that is used to determine if the fallopian tubes are open and free of disease. It is commonly done in women with an infertility diagnosis. The investigators usually do this test in the first 10 days of the menstrual cycle. Sometimes the tubes will appear to be blocked on the HSG when they are actually open. The timing of the HSG study during the menstrual cycle, or the use of hormonal contraception may make a difference in whether the tubes appear blocked on the HSG when they are actually patent.
The results of the HSG test provide a good model for how our nonsurgical permanent contraception method might work. The investigators think that if the tubes are not patent, that our treatment will not work as well. Therefore, in this study we want to learn if menstrual cycle timing or current hormonal contraception use will affect the patency of the tubes as assessed by the HSG. The investigators want to examine the same women to see if tubal patency is changes during the menstrual cycle and during the use of a birth control pill and the birth control shot.
- Conditions
- Tubal Patency
- Being tested
- combined oral contraceptive, DepoProvera
- Keywords
- hysterosalpingography, DMPA, combined oral contraceptive, tubal patency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined oral contraceptiveDrug
Also called pill, birth control pill, COC
combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption
DepoProveraDrug
Also called Depo-medroxyprogesterone acetate, DMPA
injectable hormonal contraceptive
| Study group | Role | What they receive |
|---|---|---|
| HSG Studies | Experimental | Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).
2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill. Receives: Drug: combined oral contraceptive; Drug: DepoProvera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Bilateral Tubal Patency as Assessed by HSG-follicular
Assessment of patency at follicular phase exam
Measured: follicular phase HSG
Number of Participants With Bilateral Tubal Patency as Assessed by HSG - Luteal
Assessment of patency at luteal phase exam
Measured: luteal phase HSG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tubal PatencyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Jensen
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor-investigator, Jeffrey Jensen, Oregon Health and Science University
- Investigators
- Jeffrey Jensen, MD MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146248
- Sponsor's protocol ID
- OHSU IRB 10103
- Status last verified
- Feb 2017
- First submitted
- 21 May 2014
- Last updated
- 22 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tubal Patency During the Menstrual Cycle and During Treatment With Hormonal Contraceptives: a Pilot Study in Women
- ClinicalTrials.gov ID
- NCT02146248
- Acronym / sponsor ID
- OHSU IRB 10103
- Conditions
- Tubal Patency
- Keywords
- hysterosalpingography, DMPA, combined oral contraceptive, tubal patency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Jeffrey JensenUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Posted 20 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators' research group is working to develop a highly effective, low cost non-surgical method of permanent contraception for women. To support this goal, we need to know more about the normal fallopian tube (tube that passes the egg from the ovary into the womb). The purpose of this study is to learn about how menstrual cycles and hormonal contraceptives affect tubal patency. Normally there is an opening between the tube and uterus to permit the flow of fluid and cells. If this opening is blocked, this can result in infertility. Tubal patency is when a woman's fallopian tubes are not blocked. Tubal patency is determined by an x-ray test called a hystero-(uterus)salpingo-(fallopian tube)graphy (HSG). HSG is a standard radiological imaging study that is used to determine if the fallopian tubes are open and free of disease. It is commonly done in women with an infertility diagnosis. The investigators usually do this test in the first 10 days of the menstrual cycle. Sometimes the tubes will appear to be blocked on the HSG when they are actually open. The timing of the HSG study during the menstrual cycle, or the use of hormonal contraception may make a difference in whether the tubes appear blocked on the HSG when they are actually patent.
The results of the HSG test provide a good model for how our nonsurgical permanent contraception method might work. The investigators think that if the tubes are not patent, that our treatment will not work as well. Therefore, in this study we want to learn if menstrual cycle timing or current hormonal contraception use will affect the patency of the tubes as assessed by the HSG. The investigators want to examine the same women to see if tubal patency is changes during the menstrual cycle and during the use of a birth control pill and the birth control shot.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSG Studies | Experimental | Drug: combined oral contraceptive, Drug: DepoProveraWomen will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®). 2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women between 18 and 40 years old ii. In good health, with regular menstrual cycles that occur 24 - 37 days iii. No current use of hormonal contraception or an intrauterine device and having had at least one complete menstrual cycle since having stopped hormonal contraception before starting the treatment.
- Have a negative urine pregnancy test at the admission visit. v. Have a negative chlamydia test at the admission visit. vi. Not be at risk for pregnancy. They will be consistently using a non-hormonal contraception method, have a surgically sterile male partner with a vasectomy, be abstinent, or be in a same-sex relationship from the screening visit through the first study cycle. After starting the combined OC (see Visit 4 below), use of a non-hormonal method is no longer required.
- In the opinion of the investigator, willing and able to follow all study requirements, including use of the approved study medications (doxycycline, oral contraceptive and DMPA).
- Understand and sign an IRB approved inform consent form prior to screening activities.
- Will have diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤145 mm Hg after 5 minutes in sitting position.
Key exclusion criteria (11 listed)
- i. Women with menstrual cycle length of less than 24 or more than 37 days; or with spontaneous irregular menstrual cycle length with intra-individual variations of more than 5 days ii. Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test iii. Women planning pregnancy within their months of study participation iv. Currently breast-feeding or within 30 days of discontinuing breast feeding v. Current use of a hormonal IUD, or other hormonal contraception (including oral contraceptives, contraceptive vaginal rings, contraceptive patches, or contraceptive implants) within 30 days prior to screening. NOTE: Discontinuation of hormonal contraception or removal of implanted hormonal contraceptives must have been for personal reasons unrelated to the purpose of enrollment in this study.
- Undiagnosed abnormal genital bleeding vii. Known hypersensitivity to radio-opaque contrast, doxycycline, levonorgestrel, ethinyl estradiol or depo-medroxyprogesterone acetate. The active ingredients in the approved medications used in the study.
- Anomalies in the clinical exam or history done at screening visit recognized as clinically significant by the investigator.
- Unable to pass a uterine sound at the screening examination. x. A positive test for chlamydia at screening, or a history of a positive test within the last 6 months.
- A clinically significant Pap test abnormality, as managed by current local or national guidelines that would require treatment over the next 6 months.
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 |
|---|---|---|
| combined oral contraceptiveAlso: pill, birth control pill, COCcombined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption | Drug | HSG Studies |
| DepoProveraAlso: Depo-medroxyprogesterone acetate, DMPAinjectable hormonal contraceptive | Drug | HSG Studies |
Primary outcome
Number of Participants With Bilateral Tubal Patency as Assessed by HSG-follicular
Time frame: follicular phase HSG
Assessment of patency at follicular phase exam
Number of Participants With Bilateral Tubal Patency as Assessed by HSG - Luteal
Time frame: luteal phase HSG
Assessment of patency at luteal phase exam
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Women's Health Research Unit WebsiteLink provided by the sponsor.
Related trials for Tubal Patency
Recruiting
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix)
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.
Jeffrey Jensen, MD MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined oral contraceptive and DepoProvera in people with Tubal Patency, run by Jeffrey Jensen at 1 site in United States.
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 6 inclusion and 11 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 22 Mar 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 United States. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Bilateral Tubal Patency as Assessed by HSG-follicular (time frame: follicular phase HSG). The study lists 2 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 22 Mar 2017.