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

NCT06639152 | Completed DMC

• 1 other identifier: GKLW2018-23
• Study Type: interventional
• Target: 1,187
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Infertility; Hysterosalpingography; Fertility outcome; oil-based contrast medium; water-based contrast medium

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• clinical pregnancy

  From enrollment to the end of treatment at 6 months

• ongoing pregnancy

  From enrollment to the end of treatment at 6 months

• miscarriage

  From enrollment to the end of treatment at 6 months

• ectopic pregnancy

  From enrollment to the end of treatment at 6 months

Study Arms (2)

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)

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)

Drug: water-based contrast medium

Interventions

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.

oil-based contrast medium

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.

warer-based contrast medium

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Peace Maternity and Child Health Hospital: lead

Study Sites (1)

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

Shanghai, 200030, China

Location

Related Publications (1)

• 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.

  PMID: 40816246 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jian Zhang

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 15, 2024
• Study Start: May 4, 2020
• Primary Completion: August 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 15, 2024

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results

Locations

CN (1)