An interventional study of intrauterine insemination in Male Factor Infertility, sponsored by Umraniye Education and Research Hospital. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Umraniye Education and Research Hospital · Not applicable, Interventional, and Treatment
The aim of the study is to compare the pregnancy outcomes of single vs double intrauterine insemination (IUI) in couples with male factor infertility.
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 264 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Umraniye Education and Research Hospital is the lead sponsor of 60 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: 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.
Procedure: intrauterine insemination
Giving washed sperm concentrate into uterine cavity via a soft catheter
Rate of clinical pregnancy
Pregnancy with fetal cardiac activity diagnosed by transvaginal ultrasonography
Time frame: Within 4-6 weeks after insemination
Rate of biochemical, ectopic pregnancies and rate of miscarriages
Pregnancy outcomes including biochemical, ectopic pregnancies and miscarriages diagnosed by transvaginal ultrasonography
Time frame: Within 3 months after insemination
Plan to share: No
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Umraniye Education and Research Hospital