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

International Peace Maternity and Child Health Hospital

Status: Completed

Conditions: Infertility

Treatments: Drug: water-based contrast medium; Drug: oil-based contrast medium

Study type: Interventional

Funder types: Other

Identifiers

NCT06639152

GKLW2018-23

Details and patient eligibility

About

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.

Enrollment: 1,187 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,187 participants in 2 patient groups

oil-based contrast medium

Experimental group

Description:

oil-based contrast medium: ethiodized poppyseed oil (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 480 mg/ml)

Treatment:

Drug: oil-based contrast medium

warer-based contrast medium

Active Comparator group

Description:

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

Treatment:

Drug: water-based contrast medium