InfertilityNCT06639152
Oil-based Vs. Water-based Contrast Medium in Hysterosalpingography for Infertile Women in Improving Fertility Outcome
A study testing oil-based contrast medium and water-based contrast medium in people with Infertility, run by International Peace Maternity and Child Health Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- oil-based contrast medium and water-based contrast medium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,187 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years
- infertility for at least one year without the use of contraceptives.
Who cannot join
- 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)
- known allergy to contrast agents, specifically iodine
- male partner infertility, defined as post-wash sperm motility \<3 million/mL or \<1 million/mL without sperm washing
- contraindications for undergoing HSG
- refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai, 200030
About this study
Official title: 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.
- Conditions
- Infertility
- Being tested
- oil-based contrast medium, water-based contrast medium
- Keywords
- Infertility, Hysterosalpingography, Fertility outcome, oil-based contrast medium, water-based contrast medium
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oil-based contrast mediumDrug
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.
water-based contrast mediumDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| oil-based contrast medium | Experimental | oil-based contrast medium: ethiodized poppyseed oil (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 480 mg/ml) Receives: Drug: oil-based contrast medium |
| warer-based contrast medium | Active comparator | water-based contrast medium: Ioversol (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 320 mg/ml) Receives: Drug: water-based contrast medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth
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.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (4)
clinical pregnancy
clinical pregnancy within six months post-HSG, indicated by the detection of a gestational sac on ultrasound
Measured: From enrollment to the end of treatment at 6 months
ongoing pregnancy
ongoing pregnancy within six months after HSG, defined as the presence of a fetal heartbeat on ultrasound after 12 weeks of gestation
Measured: From enrollment to the end of treatment at 6 months
miscarriage
Miscarriage was identified by the absence of a fetal heartbeat on ultrasound or loss before 12 weeks of gestation within 6 months after HSG.
Measured: From enrollment to the end of treatment at 6 months
ectopic pregnancy
Ectopic pregnancy was defined as pregnancy where implantation occurs outside the uterine cavity within 6 months after HSG.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start4 May 2020
- Primary completion30 Aug 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,187 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Zhang, Principal investigator, International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639152
- Sponsor's protocol ID
- GKLW2018-23
- Status last verified
- Dec 2018
- First submitted
- 29 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the publication of the results
Publications
Zhu Q, Lu M, Liang G, Wang Y, Xia W, Yan L, Sun T, Mol BW, Zhang J. Oil-based vs. water-based contrast medium in hysterosalpingography for older, anovulatory, and infertile women with high-risk of tubal disease. Eur J Obstet Gynecol Reprod Biol. 2025 Sep;313:114651. doi: 10.1016/j.ejogrb.2025.114651. Epub 2025 Aug 11.
PubMed 40816246
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06639152
- Acronym / sponsor ID
- GKLW2018-23
- Conditions
- Infertility
- Keywords
- Infertility, Hysterosalpingography, Fertility outcome, oil-based contrast medium, water-based contrast medium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,187 participants (actual)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| oil-based contrast medium | Experimental | Drug: oil-based contrast mediumoil-based contrast medium: ethiodized poppyseed oil (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 480 mg/ml) |
| warer-based contrast medium | Active comparator | Drug: water-based contrast mediumwater-based contrast medium: Ioversol (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 320 mg/ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥18 years
- infertility for at least one year without the use of contraceptives.
Key exclusion criteria (5 listed)
- 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)
- known allergy to contrast agents, specifically iodine
- male partner infertility, defined as post-wash sperm motility \<3 million/mL or \<1 million/mL without sperm washing
- contraindications for undergoing HSG
- refusal to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oil-based contrast mediumIn 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. | Drug | oil-based contrast medium |
| water-based contrast mediumIn 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. | Drug | warer-based contrast medium |
Primary outcome
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.
4 secondary outcomes
clinical pregnancy
Time frame: From enrollment to the end of treatment at 6 months
ongoing pregnancy
Time frame: From enrollment to the end of treatment at 6 months
miscarriage
Time frame: From enrollment to the end of treatment at 6 months
ectopic pregnancy
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40816246Zhu Q, Lu M, Liang G, Wang Y, Xia W, Yan L, Sun T, Mol BW, Zhang J. Oil-based vs. water-based contrast medium in hysterosalpingography for older, anovulatory, and infertile women with high-risk of tubal disease. Eur J Obstet Gynecol Reprod Biol. 2025 Sep;313:114651. doi: 10.1016/j.ejogrb.2025.114651. Epub 2025 Aug 11.
- Individual participant dataSharing planned: Yes. only IPD used in the publication of the results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Zhang principal investigator
International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oil-based contrast medium and water-based contrast medium in people with Infertility, run by International Peace Maternity and Child Health Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06639152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.