Female Infertility Due to Occlusion of Fallopian TubeEarly Phase 1NCT02320006
Effect of Acupuncture on Incomplete Fallopian Tube Obstructive Infertility: Study Protocol for Trial
A Early Phase 1 study testing acupuncture in people with Female Infertility Due to Occlusion of Fallopian Tube, run by Li Liu at 1 site in China.
Trial summary
Acupuncture is one of the traditional Chinese practices widely used in China for more than 3000 years. In recent years, the use of acupuncture within infertility has gained popularity all over the world, but there is no research describing the use of acupuncture in infertility of incompletely obstructive fallopian… Read more about this study
- Who is it for?
- Ages 22 to 42 years, women only
- Conditions the study is for
- Female Infertility Due to Occlusion of Fallopian Tube
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2016
- Phase
- Early Phase 1
- 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 22 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- I.Patients between 22 and 42 years of age with infertility II.diagnosis of incomplete Fallopian tube obstruction based on one of the following conditions: a. Tubal patency test: Hydrotubation , Hysterosalpingography (HSG) or Hysterosonosalpingography (HSS) shows incomplete bilateral Fallopian tube obstruction b. Hysteroscopy: Hysteroscopic tubal cannulation hydrotubation proves bilateral tube incompletely patent. c. Laparoscopy: incomplete bilateral tubal obstruction can be displayed by the methylene blue solution through the tubes III.Other relative treatments are not carried out within two weeks IV.willing to cooperate with us V. mean infertility time is 1-5 years.
Who cannot join
- I.allergic constitution or be allergic to diatrizoate or a variety of drugs II.the infertility is not leaded by tubal obstruction ,such as Congenital Physiological defects or malformation, genetic factors, immune factors and endocrine factors III.diagnosed with uterine lesions by auxiliary examinations (endometriosis ,adenomyosis , hysteromyoma or cancer and so on ) and infertility caused by tubal tuberculosis IV. infertility factor in their male partner V.people with Serious primary diseases of cardiovascular, liver, kidney and hematopoietic systems ,patients with mental illness VI.unable to judge the therapeutic efficacy or incomplete information VII.complete bilateral tubal obstruction VIII.bilateral tubes patent IX.Not willing to give written consent to the study X. people who are pregnant XI.people with acute infection .
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
LiLiu
Harbin, Heilongjiang, 150000
liu li, doctor, 15045023666 ext. +86, liuliyouxiang2008@163.com
About this study
Acupuncture is one of the traditional Chinese practices widely used in China for more than 3000 years. In recent years, the use of acupuncture within infertility has gained popularity all over the world, but there is no research describing the use of acupuncture in infertility of incompletely obstructive fallopian tube. In this paper, we present a research design evaluating the effects of acupuncture on incomplete fallopian tube obstructive infertility. This is a randomized, control acupuncture and signal-blind trial. A total of 120 patients will be enrolled in this study and will be randomized into two groups. True acupuncture plus hydrotubation or control acupuncture plus hydrotubation will be performed for 12 weeks. The purpose of this paper is to evaluate the additional value of acupuncture on the tubal patency rate and pregnancy rate beyond Hydrotubation ,therefore to guide clinical.
- Being tested
- acupuncture
- Keywords
- hydrotubation, incomplete fallopian tube obstructive infertility, Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
For RN4、CV6 CV3 and EX-CA1, needles will be inserted vertically to the abdominal muscles. The acupuncturist can feel resistance from the tip of the needle when touching the muscles and continues to insert it to a depth of 2-3 mm and stops. For ST36 and SP6, needles will be inserted vertically to a depth of 25 mm. The needles will be manipulated with an even lifting and twisting method three times to achieve the sensation of deqi.
| Study group | Role | What they receive |
|---|---|---|
| True acupuncture plus hydrotubation | Active comparator | The treatment group will receive true acupuncture and hydrotubation,Hydrotubation (80,000 U gentamicin , 400U chymotrypsin , 5mg dexamethasone , 50ml 0.9% saline) will be performedwithin 3 7 days after the menstruation[12].We use a manometer to measure the pressure and record the number on a card, then calculate the gap of the first and last time,it continues 3 menstrual cycles. The points (points used for every participant of treatment group) include bilateral RN4、CV6、CV3、EX-CA1、ST36、SP6,All the needles will be keep in positions for 30 min.Acupuncture will be performed three times per week,for a total of 36 sessions (12 wk) Receives: Other: acupuncture |
| control acupuncture plus hydrotubation | Sham comparator | The control group will receive control acupuncture and hydrotubation.Hydrotubation (80,000 U gentamicin , 400U chymotrypsin , 5mg dexamethasone , 50ml 0.9% saline) will be performed within 3 7 days after the menstruation[12].We use a manometer to measure the pressure and record the number on a card, then calculate the gap of the first and last time,it continues 3 menstrual cycles.Two needles will be inserted in each arm, one in each shoulder and one in each upper arm at nonacupuncture pointsAll the needles will be keep in positions for 30 min. Acupuncture will be performed three times per week,for a total of 36 sessions (12 wk). Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
tubal patency rate
Measured: 3 months
Secondary outcomes (1)
pregnancy rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Infertility Due to Occlusion of Fallopian TubeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Liu, First Affiliated Hospital of Heilongjiang Chinese Medicine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320006
- Sponsor's protocol ID
- FirstHeilongjiang
- Status last verified
- Dec 2014
- First submitted
- 14 Dec 2014
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Incomplete Fallopian Tube Obstructive Infertility: Study Protocol for Trial
- ClinicalTrials.gov ID
- NCT02320006
- Acronym / sponsor ID
- FirstHeilongjiang
- Keywords
- hydrotubation, incomplete fallopian tube obstructive infertility, Acupuncture
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Li LiuUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 19 Dec 2014 (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.
Acupuncture is one of the traditional Chinese practices widely used in China for more than 3000 years. In recent years, the use of acupuncture within infertility has gained popularity all over the world, but there is no research describing the use of acupuncture in infertility of incompletely obstructive fallopian tube. In this paper, we present a research design evaluating the effects of acupuncture on incomplete fallopian tube obstructive infertility. This is a randomized, control acupuncture and signal-blind trial. A total of 120 patients will be enrolled in this study and will be randomized into two groups. True acupuncture plus hydrotubation or control acupuncture plus hydrotubation will be performed for 12 weeks. The purpose of this paper is to evaluate the additional value of acupuncture on the tubal patency rate and pregnancy rate beyond Hydrotubation ,therefore to guide clinical.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True acupuncture plus hydrotubation | Active comparator | Other: acupunctureThe treatment group will receive true acupuncture and hydrotubation,Hydrotubation (80,000 U gentamicin , 400U chymotrypsin , 5mg dexamethasone , 50ml 0.9% saline) will be performedwithin 3 7 days after the menstruation[12].We use a manometer to measure the pressure and record the number on a card, then calculate the gap of the first and last time,it continues 3 menstrual cycles. The points (points used for every participant of treatment group) include bilateral RN4、CV6、CV3、EX-CA1、ST36、SP6,All the needles will be keep in positions for 30 min.Acupuncture will be performed three times per week,for a total of 36 sessions (12 wk) |
| control acupuncture plus hydrotubation | Sham comparator | Other: acupunctureThe control group will receive control acupuncture and hydrotubation.Hydrotubation (80,000 U gentamicin , 400U chymotrypsin , 5mg dexamethasone , 50ml 0.9% saline) will be performed within 3 7 days after the menstruation[12].We use a manometer to measure the pressure and record the number on a card, then calculate the gap of the first and last time,it continues 3 menstrual cycles.Two needles will be inserted in each arm, one in each shoulder and one in each upper arm at nonacupuncture pointsAll the needles will be keep in positions for 30 min. Acupuncture will be performed three times per week,for a total of 36 sessions (12 wk). |
Who may qualify
- Ages
- 22 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- I.Patients between 22 and 42 years of age with infertility II.diagnosis of incomplete Fallopian tube obstruction based on one of the following conditions: a. Tubal patency test: Hydrotubation , Hysterosalpingography (HSG) or Hysterosonosalpingography (HSS) shows incomplete bilateral Fallopian tube obstruction b. Hysteroscopy: Hysteroscopic tubal cannulation hydrotubation proves bilateral tube incompletely patent. c. Laparoscopy: incomplete bilateral tubal obstruction can be displayed by the methylene blue solution through the tubes III.Other relative treatments are not carried out within two weeks IV.willing to cooperate with us V. mean infertility time is 1-5 years.
Key exclusion criteria (1 listed)
- I.allergic constitution or be allergic to diatrizoate or a variety of drugs II.the infertility is not leaded by tubal obstruction ,such as Congenital Physiological defects or malformation, genetic factors, immune factors and endocrine factors III.diagnosed with uterine lesions by auxiliary examinations (endometriosis ,adenomyosis , hysteromyoma or cancer and so on ) and infertility caused by tubal tuberculosis IV. infertility factor in their male partner V.people with Serious primary diseases of cardiovascular, liver, kidney and hematopoietic systems ,patients with mental illness VI.unable to judge the therapeutic efficacy or incomplete information VII.complete bilateral tubal obstruction VIII.bilateral tubes patent IX.Not willing to give written consent to the study X. people who are pregnant XI.people with acute infection .
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 |
|---|---|---|
| acupunctureFor RN4、CV6 CV3 and EX-CA1, needles will be inserted vertically to the abdominal muscles. The acupuncturist can feel resistance from the tip of the needle when touching the muscles and continues to insert it to a depth of 2-3 mm and stops. For ST36 and SP6, needles will be inserted vertically to a depth of 25 mm. The needles will be manipulated with an even lifting and twisting method three times to achieve the sensation of deqi. | Other | True acupuncture plus hydrotubation, control acupuncture plus hydrotubation |
Primary outcome
tubal patency rate
Time frame: 3 months
1 secondary outcome
pregnancy rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
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 Early Phase 1 study testing acupuncture in people with Female Infertility Due to Occlusion of Fallopian Tube, run by Li Liu at 1 site in China.
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 1 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 19 Dec 2014. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tubal patency rate (time frame: 3 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 19 Dec 2014.