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Completed

NCT Number: NCT06639152

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. live birth

    Time frame: 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 outcomes

  1. clinical pregnancy

    Time frame: 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

  2. ongoing pregnancy

    Time frame: 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

  3. miscarriage

    Time frame: 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.

  4. ectopic pregnancy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

International Peace Maternity and Child Health Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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