None listed
Conditions
Brief summary
To evaluate whether the use of intrauterine insemination with ovarian stimulation with clomiphene citrate results in improved pregnancy and live birth rates compared with expectant management for couples with unexplained infertility and a prediction score for spontaneous fertility of less than 30%.
Interventions
Intrauterine insemination with stimulation. Women randomised to intrauterine insemination will undergo three cycles of stimulated intrauterine insemination (0.5ml of sperm suspension) Clomiphene citrate ovarian stimulation protocols will be used. Clomiphene citrate will be started orally on day 2 of the menstrual cycle for 5 days. The dose of clomiphene will be determined by the clinicians based on the woman's clinical indications. On day 12 an estradiol level and ultrasound scan (USS) will be p
Intrauterine insemination with stimulation. Women randomised to intrauterine insemination will undergo three cycles of stimulated intrauterine insemination (0.5ml of sperm suspension) Clomiphene citrate ovarian stimulation protocols will be used. Clomiphene citrate will be started orally on day 2 of the menstrual cycle for 5 days. The dose of clomiphene will be determined by the clinicians based on the woman's clinical indications. On day 12 an estradiol level and ultrasound scan (USS) will be performed. If there are more than 3 follicles present the IUI will not proceed and the patient will be informed not to be sexually active. If there are less than three follicles IUI will proceed when the blood tests indicate ovulation is about to occur (usually between day 12 and 16 of the cycle). A Tomcat catheter will be used for the IUI procedure. The inseminate will be prepared using a density gradient and spermatozoa will be re-suspended in 0.5 ml of human tubal fluid. The catheter will be passed through the cervical canal high up into the uterus and the specimen slowly injected. No luteal phase support will be given.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
Unexplained infertility. Normal ovulation (or normal with ovarian stimulation). Patent fallopian tubes. Normal semen analysis (greater than or equal to 32% progressive motility, greater than or concentration equal to 15 million / ml or if the clinician believes they are a suitable candidate for IUI).
Exclusion criteria
Doccumented tubal occlusion (bilateral or unilateral). Greater than three follicles on ultrasound (exclusion of the day of ultrasoun). Azoospermia. Women with anovulation secondary to polycystic ovarian syndrome.
Outcome results
None listed