RCT of Ethiodized Poppyseed Oil VS the Second-generation Non-ionic Monomer Contrast in Hysterosalpingography of Infertile Patients.

July 3, 2018 updated by: Jing zhang, Guangzhou Women and Children's Medical Center

A Randomized, the Second-generation Non-ionic Monomer Contrast Parallel Control, Multicenter Clinical Study to Evaluate the Imaging Diagnostic Quality and Fertility Promoting Effect of Ethiodized Poppyseed Oil in Hysterosalpingography of Infertile Patients.

This study evaluates the difference of imaging diagnostic quality and fertility promoting effect in the diagnosis and treatment of infertility by hysterosalpingography between using ethiodized poppyseed oil and the second-generation non-ionic monomer contrast. Half of participants will receive ethiodized poppyseed oil for hysterosalpingography, while the other half will receive the second-generation non-ionic monomer contrast for hysterosalpingography.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing Haidian District Maternal and Child Care Service Centre
        • Contact:
          • Huichun Wang
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • The Second Affiliated Hospital of Lanzhou University
        • Contact:
          • Wuquan Wang
          • Phone Number: 13893208515
    • Guangdong
      • Guangzhou, Guangdong, China, 510623
        • Recruiting
        • Guangzhou Women and Children's Medical Center
        • Contact:
    • Guangxi
      • Liuzhou, Guangxi, China, 545000
        • Recruiting
        • Liuzhou Maternal and Child Care Service Centre
        • Contact:
          • Wenhua Qin
          • Phone Number: 13768890218
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Yanli Wang
          • Phone Number: 13838072509
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Hubei Maternal and Child Care Service Centre
        • Contact:
          • Weishun Lan
    • Hunan
      • Chenzhou, Hunan, China, 423000
        • Recruiting
        • Chenzhou First People's Hospital
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222002
        • Terminated
        • Lianyungang Maternal and Child Care Service Centre
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Maternal and Child Care Service Centre
        • Contact:
          • Wenjian Xu
          • Phone Number: 13813829844
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Recruiting
        • Dalian Women and Children medical Center
        • Contact:
          • Yitang Wang
          • Phone Number: 17709887708
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • Fudan University affiliated Maternity Hospital
        • Contact:
          • Guofu Zhang
          • Phone Number: 13916104313
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Jinjiang Maternal and Child Care Service Centre
        • Contact:
          • Yichuan Tang
      • Mianyang, Sichuan, China, 621000
        • Terminated
        • Mianyang Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Aged between 21 to 39 years, Female;
  • Had spontaneous menstrual cycle;
  • Had been trying to conceive for at least 1 year;
  • There was an indication for evaluation of tubal patency by means of hysterosalpingography.
  • Understand and sign informed consent.

Exclusion Criteria:

  • Known endocrine disorders(e.g., the polycystic ovary syndrome, diabetes, hyperthyroidism, and hyperprolactinemia);
  • Less than eight menstrual cycles per year;
  • A high risk of tubal disease (as indicated by a history of pelvic inflammatory disease, previous chlamydia infection, or known endometriosis);
  • Hyperthyroidism;
  • Vaginitis, acute or subacute pelvic inflammatory active phase, uterus or fallopian tube tuberculosis;
  • Uterine or cervical bleeding;
  • Menelipsis without excluding pregnancy;
  • Severe heart disease and lung disease;
  • Body temperature beyond 37.5 ℃ within 3 days before hysterosalpingography;
  • A total motile sperm count of <1 million sperm per milliliter;
  • Complications or social environment that can cause patients to fail to follow the study plan and even endanger the patient's safety.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ethiodized poppyseed oil
Drug: ethiodized poppyseed oil
Hysterosalpingography using ethiodized poppyseed oil
Active Comparator: the second-generation non-ionic monomer contrast
Drug: the second-generation non-ionic monomer contrast
Hysterosalpingography using the second-generation non-ionic monomer contrast

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Imaging diagnostic quality of hysterosalpingography
Time Frame: procedure (during hysterosalpingography)
defined as mean scores of 3 pictures shot at certain points
procedure (during hysterosalpingography)
Ongoing pregnancy
Time Frame: 15 months （6 months for recruitment, 9 months for ongoing pregnancy）
defined as the first day of the last menstrual cycle for the pregnancy is within 6 months after randomization, and after 12 weeks of gestation a positive fetal heartbeat is on ultrasonographic examination
15 months （6 months for recruitment, 9 months for ongoing pregnancy）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou Women and Children's Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jing Zhang, Guangzhou Women and Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017102708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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