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

NCT ID: NCT03370575

Last Updated: 2018-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ethiodized poppyseed oil

Group Type EXPERIMENTAL

ethiodized poppyseed oil

Intervention Type DRUG

Hysterosalpingography using ethiodized poppyseed oil

the second-generation non-ionic monomer contrast

Group Type ACTIVE_COMPARATOR

the second-generation non-ionic monomer contrast

Intervention Type DRUG

Hysterosalpingography using the second-generation non-ionic monomer contrast

Interventions

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ethiodized poppyseed oil

Hysterosalpingography using ethiodized poppyseed oil

Intervention Type DRUG

the second-generation non-ionic monomer contrast

Hysterosalpingography using the second-generation non-ionic monomer contrast

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jing zhang

Director of medical imaging, Guangzhou Women and Children's Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jing Zhang

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Women and Children's Medical Center

Locations

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Beijing Haidian District Maternal and Child Care Service Centre

Beijing, Beijing Municipality, China

Site Status RECRUITING

The second affiliated Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status RECRUITING

Guangzhou women and children's medical center

Guangzhou, Guangdong, China

Site Status RECRUITING

Liuzhou Maternal and Child Care Service Centre

Liuzhou, Guangxi, China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Hubei Maternal and Child Care Service Centre

Wuhan, Hubei, China

Site Status RECRUITING

Chenzhou First People's Hospital

Chenzhou, Hunan, China

Site Status RECRUITING

Lianyungang Maternal and Child Care Service Centre

Lianyungang, Jiangsu, China

Site Status TERMINATED

Nanjing Maternal and Child Care Service Centre

Nanjing, Jiangsu, China

Site Status RECRUITING

Dalian Women and Children Medical Center

Dalian, Liaoning, China

Site Status RECRUITING

Fudan University affiliated Maternity Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Jinjiang Maternal and Child Care Service Centre

Chengdu, Sichuan, China

Site Status RECRUITING

Mianyang Central Hospital

Mianyang, Sichuan, China

Site Status TERMINATED

Countries

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China

Central Contacts

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Jing Zhang

Role: CONTACT

13828464628

Facility Contacts

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Huichun Wang

Role: primary

Wuquan Wang

Role: primary

13893208515

Jing Zhang

Role: primary

13828464628

Wenhua Qin

Role: primary

13768890218

Yanli Wang

Role: primary

13838072509

Weishun Lan

Role: primary

Yi Chen

Role: primary

Wenjian Xu

Role: primary

13813829844

Yitang Wang

Role: primary

17709887708

Guofu Zhang

Role: primary

13916104313

Yichuan Tang

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35399811 (View on PubMed)

Other Identifiers

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2017102708

Identifier Type: -

Identifier Source: org_study_id

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