An observational study in Infertility, sponsored by Istituto Clinico Humanitas. Completed at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by Istituto Clinico Humanitas · Observational
Multiple studies have reported on the impact of factors such as female age, duration of infertility, type of infertility, hormone levels (i.e. AMH, FSH, estradiol, progesterone), use of different ovarian stimulation protocols, timing/induction of ovulation, number of pre-ovulatory follicles, endometrial thickness by the time of ovulation, sperm parameters (i.e. concentration, progressive motility, morphology, total motile sperm count [TMSC], inseminating motile count [IMC]) and sperm washing procedures. Also the influence of body mass index and smoking on IUI outcome have been studied before. However, results on the predictive value of these parameters remain highly contradictory. The aim of the study is to examine the value of different variables in the prediction of IUI success to develop a clinically useful predictive model of pregnancy and live birth.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 2,970 is above the median of 200 across 714 observational studies indexed under Infertility.
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The included couples were subjected to an infertility diagnostic work-up. The tests included collecting medical history, physical examination, transvaginal ultrasound, serum hormone assays between day 2 and 4 of the menstrual cycle, semen analysis, uterine cavity and tubal patency evaluation with hysterosalpingography (HSG) or hysterosonosalpingography (HSSG) and/or hysteroscopy and video laparoscopy. Assessment of vaginal infection with cervico-vaginal swab and cultures
Inclusion Criteria:
all the IUI with controlled ovarian stimulation cycles in an academic tertiary ART center between January 1997 and December 2017
Procedure: Homologous intrauterine insemination (IUI)
Patients were treated with HMG/rFSH according to classic protocols of therapy and monitoring. An injection of uHCG 5000 IU/ rHCG 250 mg was given to trigger ovulation. On the day of insemination, the semen sample was obtained through masturbation after a 2-5 day abstinence period and collected in a sterile cup. TMSC was determined by multiplying grade A or grade A + B sperm motility percentages by sperm volume and concentration. To evaluate sperm viability Eosin and Nigrosin (E\&N) staining was carried out according to WHO standards. Sperm capacitation was performed using density gradient centrifugation or swim-up procedure in order to remove seminal fluids and enhance sperm quality for IUI. IUI was performed a t36 hours post-HCG. A fraction of the washed motile spermatozoa was inserted up to the uterine fundus and expelled into the uterine cavity. Daily treatment with micronized progesterone was prescribed for 14 days after IUI. Serum ß-HCG was determined 14 days after IUI.
clinical pregnancy rate (CPR)
Time frame: 1997-2017
live-birth rate (LBR)
Time frame: 1997 - 2017
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Istituto Clinico Humanitas