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Status unknownNCT03370575Updated Jul 5, 2018

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

A Phase 4 interventional study of ethiodized poppyseed oil and the second-generation non-ionic monomer contrast in Infertility, Female, sponsored by Guangzhou Women and Children's Medical Center. Status unknown at 13 sites in China. Open to female participants aged 21 Years to 39 Years. Per ClinicalTrials.gov, last updated 2018-07-05.

Sponsored by Guangzhou Women and Children's Medical Center · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
21 Years to 39 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility, Female
03

Who can participate

Ages eligible
21 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
900 participants (estimated)

Study arms

  • Experimental
    ethiodized poppyseed oil

    Drug: ethiodized poppyseed oil

  • Active comparator
    the second-generation non-ionic monomer contrast

    Drug: the second-generation non-ionic monomer contrast

Interventions

  • Drugethiodized poppyseed oil

    Hysterosalpingography using ethiodized poppyseed oil

  • Drugthe second-generation non-ionic monomer contrast

    Hysterosalpingography using the second-generation non-ionic monomer contrast

05

What researchers measure

Primary outcomes

  1. Imaging diagnostic quality of hysterosalpingography

    defined as mean scores of 3 pictures shot at certain points

    Time frame: procedure (during hysterosalpingography)

  2. 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

    Time frame: 15 months （6 months for recruitment, 9 months for ongoing pregnancy）

06

Study locations

10 of 13 sites recruiting
  • Beijing Haidian District Maternal and Child Care Service Centre
    Beijing, Beijing 100000, China
    • Huichun Wang · Contact
    Recruiting
  • The second affiliated Hospital of Lanzhou University
    Lanzhou, Gansu 730000, China
    • Wuquan Wang · Contact · 13893208515
    Recruiting
  • Guangzhou women and children's medical center
    Guangzhou, Guangdong 510623, China
    Recruiting
  • Liuzhou Maternal and Child Care Service Centre
    Liuzhou, Guangxi 545000, China
    • Wenhua Qin · Contact · 13768890218
    Recruiting
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450000, China
    • Yanli Wang · Contact · 13838072509
    Recruiting
  • Hubei Maternal and Child Care Service Centre
    Wuhan, Hubei 430000, China
    • Weishun Lan · Contact
    Recruiting
  • Chenzhou First People's Hospital
    Chenzhou, Hunan 423000, China
    • Yi Chen · Contact
    Recruiting
  • Lianyungang Maternal and Child Care Service Centre
    Lianyungang, Jiangsu 222002, China
    Terminated
  • Nanjing Maternal and Child Care Service Centre
    Nanjing, Jiangsu 210000, China
    • Wenjian Xu · Contact · 13813829844
    Recruiting
  • Dalian Women and Children Medical Center
    Dalian, Liaoning 116000, China
    • Yitang Wang · Contact · 17709887708
    Recruiting
  • Fudan University affiliated Maternity Hospital
    Shanghai, Shanghai 200000, China
    • Guofu Zhang · Contact · 13916104313
    Not yet recruiting
  • Jinjiang Maternal and Child Care Service Centre
    Chengdu, Sichuan 610000, China
    • Yichuan Tang · Contact
    Recruiting
  • Mianyang Central Hospital
    Mianyang, Sichuan 621000, China
    Terminated
07

References and documents

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. PubMed 35399811 ↗

Individual participant data

Plan to share: Undecided — It is not yet known if there will be a plan to make IPD available.

08

Registry details

Key details

Study ID
NCT03370575
Lead sponsor
Guangzhou Women and Children's Medical Center
Responsible party
Jing zhang (Director of medical imaging, Guangzhou Women and Children's Medical Center, Guangzhou Women and Children's Medical Center) — Principal investigator
First posted
Dec 12, 2017
Start date
Jan 31, 2018
Primary completion
May 1, 2019 (estimated)
Completion
May 1, 2020 (estimated)
Last update
Jul 5, 2018

Study contacts

Jing Zhang
Contact
fejr@foxmail.com
13828464628
Jing Zhang
principal investigator · Guangzhou Women and Children's Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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