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

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: Unknown
• Conditions: Infertility, Female
• Intervention / Treatment: Drug: ethiodized poppyseed oil; Drug: the second-generation non-ionic monomer contrast

• Study Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jing Zhang; Phone Number: 13828464628; Email: fejr@foxmail.com

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: Jing Zhang; Phone Number: 13828464628; Email: fejr@foxmail.com
  • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Imaging diagnostic quality of hysterosalpingography	defined as mean scores of 3 pictures shot at certain points	procedure (during hysterosalpingography)
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

• Sponsor: Guangzhou Women and Children's Medical Center
• Investigators: Principal Investigator: Jing Zhang, Guangzhou Women And Children's Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID 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