Infertility
Conditions
Keywords
Infertility, Hysterosalpingography, Fertility outcome, oil-based contrast medium, water-based contrast medium
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.
Interventions
DRUGoil-based contrast medium
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.
DRUGwater-based contrast medium
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.
Sponsors
International Peace Maternity and Child Health Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed