Project description:BackgroundLetrozole has been proven to be an effective method for inducing ovulation. However, little attention has been paid to whether the lead follicle size will affect the success rate of intrauterine insemination (IUI) with ovulation induction with alone letrozole. Therefore, we hope to investigate the effect of dominant follicle size on pregnancy outcomes on human chorionic gonadotropin (hCG) day of the first letrozole-IUI.MethodsA retrospective cohort study design was employed. We included patients with anovulation or unexplained infertility undergoing first IUI treatment with letrozole for ovarian stimulation. According to the dominant follicle size measured on the day of hCG trigger, patients were divided into six groups (≤ 18 mm, 18.1-19.0 mm, 19.1-20.0 mm, 20.1-21.0 mm, 21.1-22.0 mm, > 22 mm). Logistic models were used for estimating the odds ratios (ORs) with their 95% confidence interval (CIs) for achieving a clinical pregnancy or a live birth. A restricted cubic spline was drawn to explore the nonlinear relationship between follicle size and IUI outcomes.ResultsA total of 763 patients underwent first letrozole-IUI cycles in our study. Fisher exact test showed significant differences among the six follicle-size groups in the rates of pregnancy, clinical pregnancy and live birth (P < 0.05 in each group). After adjusting the potential confounding factors, compared with the follicles ≤ 18 mm in diameter group, 19.1-20.0 mm, 20.1-21.0 mm groups were 2.3 or 2.56 times more likely to get live birth [adjusted OR = 2.34, 95%CI (1.25-4.39); adjusted OR = 2.56, 95% CI (1.30-5.06)]. A restricted cubic spline showed an inverted U-shaped relationship between the size of dominant follicles and pregnancy rate, clinical pregnancy rate, and live birth rate, and the optimal follicle size range on the day of hCG trigger was 19.1-21.0 mm. When the E2 level on the day of hCG trigger was low than 200 pg/mL, the clinical pregnancy rates of 19.1-20.0 mm, 20.1-21.0 mm groups were still the highest.ConclusionsThe optimal dominant follicle size was between 19.1 and 21.0 mm in hCG-triggered letrozole-IUI cycles. Either too large or too small follicles may lead to a decrease in pregnancy rate. Using follicle size as a predicator of pregnancy outcomes is more meaningful when estrogen on the day of hCG trigger is less than 200 pg/ml.
Project description:ObjectiveTo evaluate the relationship between semen regurgitation and intrauterine insemination (IUI) outcomes. We hypothesized that clinical pregnancy rates and live birth rates would be reduced when regurgitation occurred.DesignRetrospective cohort study.SettingA university-based reproductive endocrinology and infertility clinic.Patient(s)Retrospective review of 1,957 IUI cycles performed on 660 patients between July 2007 and May 2012.Intervention(s)None.Main outcome measure(s)The primary outcome was live birth. Secondary outcomes were positive serum pregnancy result and clinical pregnancy. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated using a cluster-weighted generalized estimating equations method to estimate modified Poisson regression models with robust standard errors to account for multiple IUI cycles in the same patient.Result(s)Live birth rates were similar in IUI cycles with and without regurgitation (6.3% vs. 6.8%, respectively, RR = 0.82, 95% CI [0.53-1.26]). Clinical pregnancy rates in the presence or absence of regurgitation were 10.5% vs. 10.0% (RR = 0.99, 95% CI [0.73-1.35]). Positive serum pregnancy tests after IUI did not differ by regurgitation status (15.0% vs. 15.4%, RR = 0.97, 95% CI [0.75-1.24]). Results were unchanged when adjusted for covariates (age, race and ethnicity, body mass index, duration of infertility, medication, infertility diagnosis, total motile count, and method of sperm preparation).Conclusion(s)The presence of regurgitation during the IUI procedure is not related to pregnancy outcome.
Project description:BackgroundIn the current context of a global pandemic it is imperative for fertility clinics to consider the necessity of individual tests and eliminate those that have limited utility and may impose unnecessary risk of exposure. The purpose of this study was to implement and evaluate a multi-modal quality improvement (QI) strategy to promote resource stewardship by reducing routine day 3 (d3) bloodwork and transvaginal ultrasound (TVUS) for patients undergoing intrauterine insemination (IUI) and timed intercourse (IC) treatment cycles.MethodsAfter literature review, clinic stakeholders at an academic fertility centre met to discuss d3 testing utility and factors contributing to d3 bloodwork/TVUS in IC/IUI treatment cycles. Consensus was reached that it was unnecessary in patients taking oral/no medications. The primary intervention changed the default setting on the electronic order set to exclude d3 testing for IC/IUI cycles with oral/no medications. Exceptions required active test selection. Protocols were updated and education sessions were held. The main outcome measure was the proportion of cycles receiving d3 bloodwork/TVUS during the 8-week post-intervention period compared with the 8-week pre-intervention period. Balancing measures included provider satisfaction, pregnancy rates, and incidence of cycle cancellation.ResultsA significant reduction in the proportion of cycles receiving d3 TVUS (57.2% vs 20.8%, p < 0.001) and ≥ 1 blood test (58.6% vs 22.8%, p < 0.001) was observed post-intervention. There was no significant difference in cycle cancellation or pregnancy rates pre- and post-intervention (p = 0.86). Treatment with medications, cyst history, prescribing physician, and treatment centre were associated with receiving d3 bloodwork/TVUS. 74% of providers were satisfied with the intervention.ConclusionA significant reduction in IC/IUI treatment cycles that received d3 bloodwork/TVUS was achieved without measured negative treatment impacts. During a pandemic, eliminating routine d3 bloodwork/TVUS represents a safe way to reduce monitoring appointments and exposure.
Project description:Hysterosalpingography (HSG) is the most commonly applied tubal patency test in clinical practice. Although some studies have found an increased pregnancy rate after HSG, no studies to date have specifically characterized the effect of interval time between HSG and IUI on pregnancy outcome. To investigate the effect of interval time between HSG and intrauterine insemination (IUI) on live birth rates of infertile patients. Retrospective cohort study. The reproductive medical record system was used to identify patients who completed ≥1 IUI cycle between January 2017 and October 2021. According to the interval time between HSG and IUI, patients were divided into three groups: <6months interval group,6-12 months interval group and >12 months interval group. The generalized estimating equation with Poisson distribution was used to estimate the risk ratios (RRs) and 95% confidence intervals (CIs) of different groups. A total of 413 patients completed 701 IUI cycles during the study period, <6months interval group, 415 cycles; 6-12 months interval group, 138 cycles; >12 months interval group, 148 cycles. The live birth rate of <6 months group was higher than other two groups (17.35% vs. 12.32% vs. 8.11%, P=0.017); Similarly, the clinical pregnancy rate of <6 months group was also higher than other two groups (19.76% vs. 14.49% vs.11.49%, P=0.049). When adjusted separately for FSH, AMH, infertility type, duration of infertility, infertility diagnosis, total motile count (TMC) of sperm, medications, endometrium size and dominant follicle size, the live birth rate of >12 months group severally significantly decreased by 60% (adjusted RR = 0.40, 95% CI [0.19-1.40]). The cumulative clinical pregnancy and live birth rates of <6 months group were higher than other two groups (P<0.05), but the cumulative pregnancy rate among three groups were not statistically different (log rank test: P=0.06). The interval time between hysterosalpingography and IUI is related to pregnancy outcome. The clinical pregnancy and live birth rates were the highest when the time interval was less than 6 months. Therefore, IUI should be recommend as soon as possible after HSG if the patient couple meets the IUI indication.
Project description:OBJECTIVE: To evaluate the impact of follicle rupture on pregnancy rate in intrauterine insemination. MATERIAL AND METHOD: Retrospective cohort study. Evidence of follicle rupture was assessed by transvaginal ultrasonography following IUI. Two hundred ninety-six couples with unexplained infertility and 121 couples with male factor subfertility were included. Results of 578 cycles were analyzed here. RESULT: Clinical pregnancy rate was 23.5% (64/272) in the group when follicle rupture was evident by transvaginal ultrasonography, while it was only 8.8% (27/306) when follicle rupture was not evident (p < 0.001). CONCLUSION: Postponing IUI until observation of follicle rupture may yield a higher pregnancy rate.
Project description:BackgroundThe aim of this randomized controlled trial was to compare the efficacy of extended letrozole regimen with clomiphene citrate in women with unexplained infertility undergoing superovulation and intrauterine insemination (IUI).MethodsTwo hundred and fourteen patients with unexplained infertility were randomized into two equal groups using computer generated list and were treated by either letrozole 2.5 mg/day from cycle day 1 to 9 (extended letrozole group, 211 cycles) or clomiphene citrate 100 mg/day from cycle day 3 to 7 (clomiphene citrate group,210 cycles). Intrauterine insemination was performed 36 to 40 hours after HCG administration.ResultsBoth groups were comparable with regard to number of mature follicles (2.24 +/- 0.80 Vs 2.13 +/- 0.76) and the day of HCG administration. Serum estradiol was significantly greater in clomiphene citrate group (356 +/- 151 Vs 822 +/- 302 pg/ml, P = < 0.001) and the endometrial thickness was significantly greater in extended letrozole group (9.10 +/- 1.84 Vs 8.18 +/- 1.93 mm, P = < 0.001).The pregnancy rate per cycle and cumulative pregnancy rate were significantly greater in extended letrozole group (18.96% Vs 11.43% and 37.73% Vs 22.86%, respectively).ConclusionThe extended letrozole regimen had a superior efficacy as compared with clomiphene citrate in patients of unexplained infertility undergoing superovulation and IUI.Trial registrationClinicalTrials.gov, NCT01232075.
Project description:ObjectiveTo determine whether men with unexplained infertility and low total T (TT) have abnormal spermatogenesis and lower fecundity.DesignSecondary analysis of the prospective, randomized, multicenter clinical trial, Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS).SettingInfertility clinics.Patient(s)Nine hundred couples with unexplained infertility enrolled in AMIGOS. Semen analysis with an ejaculate of at least 5 million total motile sperm was required for enrollment. For inclusion in this secondary analysis, a fasting TT was required.Intervention(s)None.Main outcome measure(s)Logistic regression, adjusted for age and body mass index, assessed the association between low TT (defined as <264 ng/dL), semen parameters, and pregnancy outcome.Result(s)Seven hundred eighty-one men (mean age, 34.2 ± 5.7 years) with a median (interquartile range) TT of 411 (318-520) ng/dL were included. Men with TT <264 ng/dL were less likely to have normal (≥4% strict Kruger) morphology (unadjusted odds ratio [OR], 0.56; 95% confidence interval [CI], 0.34, 0.92; adjusted OR, 0.59; 95% CI, 0.35, 0.99). There was no association between low TT and semen volume < 1.5 mL, sperm concentration < 15 × 106/mL, or motility < 40%. Among couples whose male partner had low TT, 21 (18.8%) had a live birth, compared with 184 (27.5%) live births in couples with a male partner having TT > 264 ng/dL. The odds of live birth decreased by 40% in couples whose male partner had low TT (unadjusted OR, 0.60; 95% CI, 0.36, 1.00; adjusted OR, 0.65; 95% CI, 0.38, 1.12).Conclusion(s)In couples with unexplained infertility, low TT in the male partner was associated with abnormal sperm morphology and lower live birth rates.Clinical trial registration numberNCT01044862.
Project description:BackgroundDecreased endometrial thickness (EMT) has been suggested to be associated with reduced birthweight of in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) newborns. Considering the differences in ovarian stimulation degree and laboratory procedures between IVF/ICSI and IUI treatment, we aim to investigate whether EMT has any influence on IUI infant outcomes as well.MethodsThis was a retrospective cohort study of 1016 patients who had singleton livebirths after IUI treatment cycles from January 2008 to December 2018 at a tertiary-care academic medical center in China. Patients were categorized into three groups by the 10th and 90th percentile of peak EMT: ≤7.6, 7.7-13.0 and ≥ 13.1 mm. The primary outcomes of the study were preterm birth (PTB), low birthweight (LBW) and small-for-gestational age (SGA). Multiple regression analyses were performed after controlling for a variety of potential confounders.ResultsNo significant differences were found among the three groups in gestational age, birthweight and birthweight Z-score. Compared with the EMT 7.7-13.0 mm group, the incidences of PTB, LBW and SGA were 5.5% (adjusted odds ratio [aOR] 0.81, 95% confidence interval [CI] 0.33-2.01), 6.4% (aOR 1.44, 95% CI 0.58-3.58) and 7.3% (aOR 1.21, 95% CI 0.53-2.76) in the EMT ≤7.6 mm group, respectively. Similarly, EMT ≥13.1 mm was not significantly associated with risks of PTB (aOR 0.63, 95% CI 0.24-1.65), LBW (aOR 0.57, 95% CI 0.17-1.95) and SGA (aOR 0.73, 95% CI 0.28-1.92). The odds of other adverse neonatal outcomes, including macrosomia, large-for-gestational age and major congenital malformations, did not show significant differences before and after adjustment in both EMT ≤7.6 and ≥ 13.1 mm groups.ConclusionsEMT is not independently associated with adverse perinatal outcomes in IUI cycles. This novel finding would provide reassuring information for IUI patients with thin endometrial linings regarding their neonatal health. However, further prospective cohort studies with larger datasets are needed to confirm the conclusion.
Project description:Sperm preparation is critical to achieving a successful intrauterine insemination and requires the processing of a semen sample to remove white blood cells, wash away seminal plasma, and reduce sample volume. We present an automated instrument capable of performing a sperm preparation starting with a diluted semen sample. We compare our device against a density gradient centrifugation by processing 0.5 mL portions of patient samples through each treatment. In 5 min of operating time, the instrument recovers an average of 86% of all sperm and 82% of progressively motile sperm from the original sample while removing white blood cells, replacing the seminal plasma, and reducing the volume of the sample to the clinically required level. In 25 min of operating time, density gradient centrifugation recovers an average of 33% of all sperm and 41% of progressively motile sperm. The automated instrument could improve access to IUI as a treatment option by allowing satellite doctor's offices to offer intrauterine insemination as an option for patients without the clinical support required by existing methods.
Project description:ObjectiveTo investigate the association of non-cavity-distorting uterine fibroids and pregnancy outcomes after ovarian stimulation-intrauterine insemination (OS-IUI) in couples with unexplained infertility.DesignSecondary analysis from a prospective, randomized, multicenter clinical trial investigating fertility outcomes after OS-IUI.SettingReproductive Medicine Network clinical sites.Patient(s)Nine hundred couples with unexplained infertility who participated in the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial.Intervention(s)Participants were randomized to one of three arms (clomiphene citrate, letrozole, or gonadotropins), and treatment was continued for up to four cycles or until pregnancy was achieved.Main outcomes measure(s)Conception (serum hCG increase), clinical pregnancy (fetal cardiac activity), and live birth rates.Result(s)A total of 102/900 participants (11.3%) had at least one documented fibroid and a normal uterine cavity. Women with fibroids were older, more likely to be African American, had a greater uterine volume, lower serum antimüllerian hormone levels, and fewer antral follicles than women without fibroids. In conception cycles, clinical pregnancy rates were significantly lower in participants with fibroids than in those without uterine fibroids. Pregnancy loss before 12 weeks was more likely in African American women with fibroids compared with non-African American women with fibroids. There was no difference in conception and live birth rates in subjects with and without fibroids.Conclusion(s)No differences were observed in conception and live birth rates in women with non-cavity-distorting fibroids and those without fibroids. These findings provide reassurance that pregnancy success is not impacted in couples with non-cavity-distorting fibroids undergoing OS-IUI for unexplained infertility.Clinical trial registration numberNCT01044862.