Double vs Single Intrauterine Insemination in Male Factor Infertility
- Conditions
- Male Factor Infertility
- Interventions
- Procedure: intrauterine insemination
- Registration Number
- NCT05885516
- Lead Sponsor
- Umraniye Education and Research Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 264
- Couples trying to conceive for at least 6 months despite of regular sexual intercourse
- Female partner between 18-40 years old
- Male partner sperm analysis total motile sperm count between 1-10 million in at least 2 sperm analysis on different days.
- No patent fallopian tubes shown in hystero-salpingography
- Female partner with a uterine anomaly
- History of a previous ovarian surgery
- Known or suspected endometriosis in female partner
- Body-mass index (BMI) > 40 kg/m2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double intrauterine insemination group intrauterine insemination When the leading follicle is greater than 17 mm following ovulation induction with follicle stimulating hormone (FSH) daily injections, ovulation trigger injection will be given to the participant. 24 and 48 hours after ovulation trigger injection intrauterine insemination will be done twice with partner's sperm collected on the specified days. Single intrauterine insemination group intrauterine insemination When the leading follicle is greater than 17 mm following ovulation induction with follicle stimulating hormone (FSH) daily injections, ovulation trigger injection will be given to the participant. 36 hours after ovulation trigger injection single intrauterine insemination with partner's sperm collected on the same day will be done.
- Primary Outcome Measures
Name Time Method Rate of clinical pregnancy Within 4-6 weeks after insemination Pregnancy with fetal cardiac activity diagnosed by transvaginal ultrasonography
- Secondary Outcome Measures
Name Time Method Rate of biochemical, ectopic pregnancies and rate of miscarriages Within 3 months after insemination Pregnancy outcomes including biochemical, ectopic pregnancies and miscarriages diagnosed by transvaginal ultrasonography
Trial Locations
- Locations (1)
Umraniye Training and Research Hospital
🇹🇷Istanbul, Turkey