NCT05885516

Double vs Single Intrauterine Insemination in Male Factor Infertility

Double vs Single Intrauterine Insemination in Male Factor Infertility - a Multicenter Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Umraniye Education and Research Hospital · Other Government
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to compare the pregnancy outcomes of single vs double intrauterine insemination (IUI) in couples with male factor infertility.

Detailed description

The principle behind double intrauterine insemination in male factor infertility couples is to create a longer time frame for fertilization and to increase motile sperm number in female genital tract in order to increase pregnancy rates. There's a clinical equipoise on the benefits of performing double IUI in couples following ovarian hyperstimulation with daily follicle stimulating hormone injections in male factor subfertility. As it is stated in Cochrane database, there's a need for adequately powered, randomized, high-quality studies on this subject. In this study, as a result of a-priori power analysis 132 participants in each study arm is planned to be recruited in the study. Male factor infertility included in the study is defined as total motile sperm count (TPMSC) less than 10 million. TPMSC less than 1 million, female age greater than 40, uterine anomaly, no patent tubes shown in hysterosalpingography, history of ovarian surgery and known endometriosis will be excluded. Couples with two basal semen analysis with TPMSC between 1-10 million will be randomized to single or double IUI procedure. To accomplish this in approximately 1 year period, the study is planned as a multi-center study. The objective of the study is to compare the pregnancy outcomes of single and double intrauterine insemination groups, following ovarian hyperstimulation in couples with male factor subfertility.

Conditions

• Male Factor Infertility

Interventions

Type	Name	Description
PROCEDURE	intrauterine insemination	Giving washed sperm concentrate into uterine cavity via a soft catheter

Timeline

• Start date: 2023-06-05
• Primary completion: 2024-11-22
• Completion: 2024-12-22
• First posted: 2023-06-02
• Last updated: 2023-12-05

Locations

1 site across 1 country: Turkey (Türkiye)