Clinical trial NCT06639152: Oil-based Vs. Water-based Contrast Medium in Hysterosalpingography for Infertile Women in Improving Fertility Outcome
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Infertility
Hysterosalpingography
Fertility outcome
oil-based contrast medium
water-based contrast medium
Lead sponsor: International Peace Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 1187
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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\&#39; 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.


Eligibility criteria: 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 \&lt;3 million/mL or \&lt;1 million/mL without sperm washing
4. contraindications for undergoing HSG
5. refusal to provide informed consent.

Primary outcomes:
measure: live birth
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: clinical pregnancy
timeFrame: From enrollment to the end of treatment at 6 months
measure: ongoing pregnancy
timeFrame: From enrollment to the end of treatment at 6 months
measure: miscarriage
timeFrame: From enrollment to the end of treatment at 6 months
measure: ectopic pregnancy
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Study officials:
affiliation: International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
name: Jian Zhang
role: PRINCIPAL_INVESTIGATOR
References: