Oil-based Vs. Water-based Contrast Medium in Hysterosalpingography for Infertile Women in Improving Fertility Outcome

October 11, 2024 updated by: International Peace Maternity and Child Health Hospital

A Comparative Study on the Effect of Oil-based Versus Water-based Contrast Agents in Hysterosalpingography on Improving the Ongoing Pregnancy Rate in Infertile Women: a Prospective Cohort Study.

The goal of this clinical trial is to compare the effects of oil-based contrast medium (OBCM) and water-based contrast medium (WBCM) during hysterosalpingography（HSG）on pregnancy outcomes in infertile women. The main question it aims to answer is whether an oil-based contrast medium improves fertility outcomes in infertile women. Participants were divided into those who received an oil-based contrast medium (ethiodized poppyseed oil) and a water-based contrast medium (Ioversol) based on a shared medical decision-making process between patients and healthcare providers. The two contrast agents used in this study are routinely employed in clinical practice and will not affect the participants' health. Participants are required to complete some clinical questionnaires before and after the HSG procedure to provide clinical information. Other than that, there will be no additional costs for participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1187

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200030
        • International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age ≥18 years
  2. infertility for at least one year without the use of contraceptives.

Exclusion Criteria:

  1. endocrine disorders, including Cushing's syndrome, hypothalamic amenorrhea, adrenal hyperplasia, diabetes, or thyroid dysfunction (except for well-controlled hypothyroidism with a TSH level between 0.3 and 4.0 mIU/L)
  2. known allergy to contrast agents, specifically iodine
  3. male partner infertility, defined as post-wash sperm motility <3 million/mL or <1 million/mL without sperm washing
  4. contraindications for undergoing HSG
  5. refusal to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: oil-based contrast medium
oil-based contrast medium: ethiodized poppyseed oil (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 480 mg/ml)
Drug: oil-based contrast medium
In oil group, ethiodized poppyseed oil (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 480 mg/ml) was used as the contrast medium for hysterosalpingography.
Active Comparator: warer-based contrast medium
water-based contrast medium: Ioversol (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 320 mg/ml)
Drug: water-based contrast medium
In water group, Ioversol (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 320 mg/ml) was used as the contrast medium for hysterosalpingography.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
live birth
Time Frame: From enrollment to the end of treatment at 6 months
The primary outcome measure is live birth from pregnancies occurring within 6 months after HSG, defined as a live birth after 24 weeks of gestation, with the last menstrual period starting within six months post-HSG.
From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
clinical pregnancy
Time Frame: From enrollment to the end of treatment at 6 months
clinical pregnancy within six months post-HSG, indicated by the detection of a gestational sac on ultrasound
From enrollment to the end of treatment at 6 months
ongoing pregnancy
Time Frame: From enrollment to the end of treatment at 6 months
ongoing pregnancy within six months after HSG, defined as the presence of a fetal heartbeat on ultrasound after 12 weeks of gestation
From enrollment to the end of treatment at 6 months
miscarriage
Time Frame: From enrollment to the end of treatment at 6 months
Miscarriage was identified by the absence of a fetal heartbeat on ultrasound or loss before 12 weeks of gestation within 6 months after HSG.
From enrollment to the end of treatment at 6 months
ectopic pregnancy
Time Frame: From enrollment to the end of treatment at 6 months
Ectopic pregnancy was defined as pregnancy where implantation occurs outside the uterine cavity within 6 months after HSG.
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Peace Maternity and Child Health Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jian Zhang, International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GKLW2018-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

only IPD used in the publication of the results

IPD Sharing Time Frame

Beginning 3 months and ending 3 years after the publication of results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings