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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Drug: oil-based contrast medium; Drug: water-based contrast medium

• Registration Number: NCT06639152
• Lead Sponsor: International Peace Maternity and Child Health Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study Start: 2020-05-04
• Primary Completion: 2023-08-30
• Study Completion: 2023-12-30
• Study First Submitted: 2024-09-29
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1187

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oil-based contrast medium	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)
warer-based contrast medium	water-based contrast medium	water-based contrast medium: Ioversol (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 320 mg/ml)

Primary Outcome Measures

Name	Time	Method
live birth	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.

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy	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
ongoing pregnancy	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
miscarriage	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.
ectopic pregnancy	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.

Trial Locations

Locations (1)

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