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

Sponsor
Guangzhou Women and Children's Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03370575
Collaborator
(none)
900
Enrollment
13
Locations
2
Arms
27
Anticipated Duration (Months)
69.2
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ethiodized poppyseed oil
  • Drug: the second-generation non-ionic monomer contrast
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jan 31, 2018
Anticipated Primary Completion Date :
May 1, 2019
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Imaging diagnostic quality of hysterosalpingography [procedure (during hysterosalpingography)]

    defined as mean scores of 3 pictures shot at certain points

  2. Ongoing pregnancy [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 39 Years
Sexes Eligible for Study:
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:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Haidian District Maternal and Child Care Service Centre Beijing Beijing China 100000
2 The second affiliated Hospital of Lanzhou University Lanzhou Gansu China 730000
3 Guangzhou women and children's medical center Guangzhou Guangdong China 510623
4 Liuzhou Maternal and Child Care Service Centre Liuzhou Guangxi China 545000
5 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450000
6 Hubei Maternal and Child Care Service Centre Wuhan Hubei China 430000
7 Chenzhou First People's Hospital Chenzhou Hunan China 423000
8 Lianyungang Maternal and Child Care Service Centre Lianyungang Jiangsu China 222002
9 Nanjing Maternal and Child Care Service Centre Nanjing Jiangsu China 210000
10 Dalian Women and Children Medical Center Dalian Liaoning China 116000
11 Fudan University affiliated Maternity Hospital Shanghai Shanghai China 200000
12 Jinjiang Maternal and Child Care Service Centre Chengdu Sichuan China 610000
13 Mianyang Central Hospital Mianyang Sichuan China 621000

Sponsors and Collaborators

  • Guangzhou Women and Children's Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jing zhang, Director of medical imaging, Guangzhou Women and Children's Medical Center, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier:
NCT03370575
Other Study ID Numbers:
  • 2017102708
First Posted:
Dec 12, 2017
Last Update Posted:
Jul 5, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility
Infertility, Female

Study Results

No Results Posted as of Jul 5, 2018