The intrauterine insemination with stimulation in women with unexplained infertility study

Phase 4

Completed

• Conditions: nexplained infertility; Unexplained infertility; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12612001025820
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 160

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative live birth rate[40 weeks after each menstrual cycle (there are three cycles for each woman).]

Secondary Outcome Measures

Name	Time	Method
clinical pregnancies based on Quantitative B-hcg level Day 16 post procedure and an ultrasound at 6 weeks to evaluate whether there is a fetal heart.[6 weeks after each menstrual cycle (there are three cycles for each woman).];Ectopic pregnancy / miscarriage[In the 40 weeks after each menstrual cycle (there are three cycles for each woman).];Multiple pregnancy rates[At 6 weeks after each menstrual cycle (there are three cycles for each woman).];Ovarian hyper stimulation syndrome. This will be determined using ultrasound examinations and by measuring estradiol levels.[During each menstrual cycle (there are three cycles for each woman).]