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

Primary Purpose

Infertility, Female

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ethiodized poppyseed oil
the second-generation non-ionic monomer contrast
Sponsored by
Guangzhou Women and Children's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

21 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Haidian District Maternal and Child Care Service CentreRecruiting
  • The second affiliated Hospital of Lanzhou UniversityRecruiting
  • Guangzhou women and children's medical centerRecruiting
  • Liuzhou Maternal and Child Care Service CentreRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Hubei Maternal and Child Care Service CentreRecruiting
  • Chenzhou First People's HospitalRecruiting
  • Lianyungang Maternal and Child Care Service Centre
  • Nanjing Maternal and Child Care Service CentreRecruiting
  • Dalian Women and Children Medical CenterRecruiting
  • Fudan University affiliated Maternity Hospital
  • Jinjiang Maternal and Child Care Service CentreRecruiting
  • Mianyang Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ethiodized poppyseed oil

the second-generation non-ionic monomer contrast

Arm Description

Outcomes

Primary Outcome Measures

Imaging diagnostic quality of hysterosalpingography
defined as mean scores of 3 pictures shot at certain points
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

Secondary Outcome Measures

Full Information

First Posted
November 29, 2017
Last Updated
July 3, 2018
Sponsor
Guangzhou Women and Children's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03370575
Brief Title
RCT of Ethiodized Poppyseed Oil VS the Second-generation Non-ionic Monomer Contrast in Hysterosalpingography of Infertile Patients.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Women and Children's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ethiodized poppyseed oil
Arm Type
Experimental
Arm Title
the second-generation non-ionic monomer contrast
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ethiodized poppyseed oil
Intervention Description
Hysterosalpingography using ethiodized poppyseed oil
Intervention Type
Drug
Intervention Name(s)
the second-generation non-ionic monomer contrast
Intervention Description
Hysterosalpingography using the second-generation non-ionic monomer contrast
Primary Outcome Measure Information:
Title
Imaging diagnostic quality of hysterosalpingography
Description
defined as mean scores of 3 pictures shot at certain points
Time Frame
procedure (during hysterosalpingography)
Title
Ongoing pregnancy
Description
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
Time Frame
15 months （6 months for recruitment, 9 months for ongoing pregnancy）

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Zhang
Phone
13828464628
Email
fejr@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Zhang
Organizational Affiliation
Guangzhou Women and Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Haidian District Maternal and Child Care Service Centre
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huichun Wang
Facility Name
The second affiliated Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wuquan Wang
Phone
13893208515
Facility Name
Guangzhou women and children's medical center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510623
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Zhang
Phone
13828464628
Email
fejr@foxmail.com
Facility Name
Liuzhou Maternal and Child Care Service Centre
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhua Qin
Phone
13768890218
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanli Wang
Phone
13838072509
Facility Name
Hubei Maternal and Child Care Service Centre
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weishun Lan
Facility Name
Chenzhou First People's Hospital
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
423000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Chen
Facility Name
Lianyungang Maternal and Child Care Service Centre
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222002
Country
China
Individual Site Status
Terminated
Facility Name
Nanjing Maternal and Child Care Service Centre
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjian Xu
Phone
13813829844
Facility Name
Dalian Women and Children Medical Center
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yitang Wang
Phone
17709887708
Facility Name
Fudan University affiliated Maternity Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guofu Zhang
Phone
13916104313
Facility Name
Jinjiang Maternal and Child Care Service Centre
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yichuan Tang
Facility Name
Mianyang Central Hospital
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
621000
Country
China
Individual Site Status
Terminated

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.
Citations:
PubMed Identifier
35399811
Citation
Zhang J, Lan W, Wang Y, Chen K, Zhang G, Yang W, Chen H, Xu W, Ma J, Qin W, Zhang Y, Wang W, Wang H, Dong Z, Wang Y, Chen Y, Gang N, Tang Y. Ethiodized poppyseed oil-based contrast medium is superior to water-based contrast medium during hysterosalpingography regarding image quality improvement and fertility enhancement: A multicentric, randomized and controlled trial. EClinicalMedicine. 2022 Apr 5;46:101363. doi: 10.1016/j.eclinm.2022.101363. eCollection 2022 Apr.
Results Reference
derived

Learn more about this trial

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

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