Male Factor Infertility
Conditions
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.
Interventions
PROCEDUREintrauterine insemination
Giving washed sperm concentrate into uterine cavity via a soft catheter
Sponsors
Umraniye Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clinical pregnancy | Within 4-6 weeks after insemination | Pregnancy with fetal cardiac activity diagnosed by transvaginal ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Turkey (Türkiye)
Contacts
Primary ContactMerve Dizdar, Speacialist
Backup ContactGürkan Bozdağ, Professor
Outcome results
None listed