The Fertility In Vitro Fertilisation (IVF) and Intrauterine Insemination (IUI) trial in couples with uneXplained infertility (The FIIX Study).

Not Applicable

Active, not recruiting

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

• Registration Number: ACTRN12619001003167
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 737

Inclusion Criteria

Inclusion criteria
1. Eligible for two packages of publicly funded fertility treatment in NZ and all of the following:
a. Age - Female <39 years 4 months and male <54 years and 4months at the time of randomisation.
b. Body mass index (BMI) - Female - BMI < /= 32.
c. Both partners are non-smokers for three months.
d. Both partners with no history of illicit drug use or alcohol abuse within the preceding 12 months.
e. Day 2 FSH <15IU for the female partner
f. Both partners must be a NZ citizen or resident, hold a NZ work visa or student visa which allows them to stay in NZ continuously for two years or more, or be an Australian citizen or resident who can prove intention to stay in NZ for two years or more.
g. Couples must have:
i. No previous children from public fertility treatment.
ii. No more than one child (including adopted children) of any age to the same relationship, or
iii. No more than one child from a previous relationship living at home (at least half of the time)
2. Female partner has a regular ovulatory cycle (21-35 days).
3. Female partner has evidence of patent fallopian tube(s) on hysterosalpingogram or at laparoscopy or recent intrauterine miscarriage (within 24 months) (tubal spasm is not considered tubal blockage).
4. Male partner has a total motile sperm count (TMSC) > 10 million, on last semen analysis or within two of the past three semen analyses.

Exclusion Criteria

1. Women with a history of stage 3 and 4 endometriosis
2. Women with submucosal fibroids or any fibroid >8cm or fibroids between 5-8cm if endometrial cavity is distorted or cavity length is >10cm.
3. Couple who require egg or sperm donation
4. Women with a past history of ectopic pregnancy or bilateral blocked tubes or tubal surgery for adhesions/hydrosalpinges.

Study & Design

• Study Type: Interventional
• Study Design: Not specified