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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oil-based contrast medium | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Zhang | International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University, School of Medicine | Shanghai | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40816246 | Derived | 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. |
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only IPD used in the publication of the results
Beginning 3 months and ending 3 years after the publication of results
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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.
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| water-based contrast medium | Drug | 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. |
|
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 | 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 | 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 |