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Results for “randomized crossover trial”

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PubMed1984

Efficacy of mexiletine in the medium-term treatment of ventricular arrhythmias. A randomized, double-blind, crossover trial against placebo in ambulatory patients.

A double-blind, crossover study was designed to compare the safety and efficacy of mexiletine with that of placebo in reducing premature ventricular complexes (PVC) in ambulatory patients and to find out the dose which gives a good therapeutic response with a minimal incidence of side-effects. Twenty-six patients, who had on average 427.9 PVCs/hour, were admitted to the study. The doses given were designed to reduce the frequency of PVCs by 50% or more from the baseline value. Two out of the twenty-six patients stopped treatment because of major side-effects. In the remaining twenty-four patients the 3 weeks of treatment with mexiletine significantly reduced the rate of PVCs by comparison with placebo (-63.8% versus +7.5%). In the nineteen responders (per cent reduction of PVCs over 50%) the dose of mexiletine was 600 mg daily (200 mg every 8 hours). In the non-responders plasma levels of mexiletine proved to be in the therapeutic range, not in any way different from responders. The most frequent side-effects were digestive difficulties (fifteen patients taking mexiletine and six taking placebo). These results show that mexiletine is an effective anti-arrhythmic drug in the management of ventricular arrhythmias occurring in ambulatory patients. In the majority of patients mexiletine was found to be effective even at the lowest dose studied of 600 mg/day.

Adult↗

PubMed1994

Thalidomide for the treatment of uremic pruritus: a crossover randomized double-blind trial.

Our observation that thalidomide administration to a dialysis patient with leprosy alleviated his pruritus led us to conduct this short-term study to assess the efficacy of the drug in this regard. From 210 hemodialysis patients, 29 cases of refractory uremic pruritus were entered into the study. Patients were instructed to score their symptoms from 0 to 3, three times a day and assigned to receive thalidomide or placebo at bed time for 7 days. After a washout period of 7 days, drugs were crossed over. Response was defined as a reduction of at least 50% in the pruritus scoring. Eighteen patients finished the study. In the first phase, 55% of patients responded showing a mean reduction in their pruritus scoring of 78% (p < 0.05 vs. placebo); no response to placebo was observed. A similar proportion of patients responded to thalidomide in the second phase with a mean reduction in their pruritus scoring of 81%. In conclusion, thalidomide can be a precious tool in the handling of uremic pruritus unresponsive to available therapy.

Aged↗

PubMed2001

Vascular Effects of ACE Inhibition Independent of the Renin-Angiotensin System in Hypertensive Renovascular Disease : A Randomized, Double-Blind, Crossover Trial.

-To evaluate whether ACE inhibition and angiotensin II type 1 blockade exert beneficial effects on NO availability independent of their blood pressure-lowering effect, we used a double-blind crossover design to study vascular function in 18 patients with hypertensive renovascular disease during 6 weeks of therapy with enalapril (Ena) and valsartan (Val) compared with non-renin-angiotensin system-mediated treatment with the alpha(1)-blocker doxazosin (Dox). Control measurements were performed in 13 age-matched volunteers. Forearm blood flow was assessed with venous occlusion plethysmography, and serotonin and nitroprusside were used as endothelium-dependent and -independent vasodilators, respectively. Blood pressure was similar during all treatment periods. Serotonin-induced vasodilation was decreased in patients during Dox treatment (n=12) compared with control subjects (n=13) (increase 42+/-20% versus 107+/-65%, P:<0.05). Crossover from Dox to Val (n=6) had no effect on serotonin response (increase 50+/-14%), but crossover to Ena (n=6) caused a significant improvement (increase 79+/-39%, P:<0.05 versus Dox). In an assessment of all patients, serotonin-induced vasodilation during Ena (n=12, increase 75+/-31%) was increased compared with both Val and Dox (43+/-14% and 42+/-20%, respectively; both P:<0.05 versus Ena). The nitroprusside response remained unaltered during all treatment periods. In conclusion, ACE inhibition improves the impaired endothelium-dependent vascular function in patients with hypertensive renovascular disease. This effect is unrelated to blood pressure-lowering or angiotensin II-mediated effects.

Journal Article↗

PubMed2002

Drug distribution for a large crossover trial of the safety of inactivated influenza vaccine in asthmatics.

We report on the drug packaging, masking, and distribution procedures for a large double-masked, randomized, controlled, crossover trial. The Study of Inactivated Influenza Vaccine in Asthmatics was performed to evaluate whether influenza vaccination was safe for asthmatics. Nineteen clinical centers enrolled 2032 participants from 15 September to 30 November 2000. The participants were assigned individual kits with two syringes (placebo and vaccine); the order of injection was randomly assigned. All participants enrolled in the trial received the first injection and 2009 participants received the second injection. Five participants received their injections in the wrong order; we have no evidence that any participant received an injection from the wrong kit. Challenges faced by the trial were a manufacturing shortage of vaccine, the lack of a commercially available placebo, short time periods for planning and startup, and a diverse set of clinical centers. Utilizing individual syringe kits, using the same identification for patient, kit, and drug assignment, and dispensing drug from a central facility helped to successfully meet these challenges.

Asthma↗

PubMed2006

The significance of crossovers after randomization in the STICH trial.

INTRODUCTION: Of all forms of stroke, spontaneous intracerebral haemorrhage (ICH) causes the highest morbidity and mortality. The Surgical Trial in Intracerebral Haemorrhage (STICH) found no difference in outcomes between patients randomized to surgical or conservative treatment. PATIENTS AND METHODS: Of 530 patients randomized to initial conservative treatment, 140 crossed over to surgery. This study examines the variables associated with crossover. RESULTS: Dominant features of the crossover group were: male, (p = 0.04), right-sided clot (p = 0.03), lobar clot (p = 0.003), clot volume (median 64 mL for crossovers vs. 38 mL for others, p < 0.00001), midline shift (median 6 mm for crossovers vs. 3 mm for others, p < 0.00001), superficial clot (median 1.3 mm for crossovers vs. 11.5 mm for others, p < 0.00001), and randomization within 12 hours of ictus (p < 0.0005). Thalamic location (p = 0.002) was under-represented. Intraventricular haemorrhage, hydrocephalus, and focal deficits were not associated with crossover. Craniotomy was the method of evacuation in 85% of crossover patients. CONCLUSIONS: Crossover to surgery was more likely when ICH had these features: Right side, lobar location, superficial, large volume, big shift, and early randomization. Crossovers formed a worse prognostic group compared to non-crossovers. Surgery did not affect trial results, which were analyzed by intention-to-treat.

Bias↗

PubMed2005

Overnight corneal reshaping versus soft disposable contact lenses: vision-related quality-of-life differences from a randomized clinical trial.

PURPOSE: The purpose of this article is to evaluate patients' visual acuity, symptoms, and perceptions of vision-related quality of life in a randomized crossover clinical trial of overnight corneal reshaping (OCR) and daily wear soft lenses (SCL). METHODS: Qualified subjects were randomly assigned to wear one mode of contact lens for 8 weeks and then, after a washout period, they wore the alternate mode for 8 weeks. On concluding each contact lens wear mode, subjects completed the NEI-RQL42 questionnaire. During the SCL mode, subjects wore lenses during their waking hours. During the OCR mode, subjects wore lenses only while sleeping. Soft lenses were Biomedics 55 2-week disposable lenses. OCR lenses were CRT lenses by Paragon. (Three subjects were fit with custom-designed OCR lenses in Boston XO material, manufactured by Art Optical.) LogMAR acuity was measured and slit lamp evaluation was performed at specified intervals during follow up. After completing both phases of the study, patients chose which mode they preferred. RESULTS: Of 81 enrolled patients, 65 completed both phases and 16 dropped out during the study. Significant differences (p<0.01) favoring SCL wear included better visual acuity and less trouble with glare. Significant differences (p<0.01) favoring OCR wear included less activity limitations, less trouble with symptoms, and less dependence on refractive correction. Of 65 completing both phases, 44 preferred the OCR lenses and 21 preferred the soft lenses. Subjects who preferred the OCR lenses were less myopic and had steeper K readings at baseline, and showed less difference between visual acuity during OCR wear and visual acuity with SCL. CONCLUSION: In subjects with mild myopia who experienced both SCL and OCR, better visual acuity and less glare resulted from SCL wear, whereas activity limitations, symptoms, and dependence on refractive correction were less troublesome with OCR wear. When the study was completed, 67.7% chose OCR lenses worn only while sleeping, whereas 32.3% preferred 2-week disposable soft lenses worn during the day as their preferred correction.

Adult↗

PubMed1985

Vegetarian diet in the treatment of mild hypertension: a randomized controlled trial.

The effect on blood pressure of an ovo-lacto-vegetarian (OLV) diet was assessed in a randomized controlled crossover trial. Fifty-eight mild untreated hypertensive subjects recruited from the Perth Centre for the 1983 National Heart Foundation (NHF) Risk Factor Prevalence Survey were randomly allocated to one of three groups: the first maintained their usual diet throughout 12 weeks; the other two were given an OLV diet for either the first or second 6 weeks of the 12-week trial. A significant fall in systolic blood pressure, on average of the order of 5 mmHg, was associated with eating an OLV diet. Blood pressure change was unrelated to change in urinary sodium, potassium or body weight, but was related to initial blood pressures. Although an OLV diet may have an adjunctive role in control of mild hypertension, in view of likely problems with acceptability the dietary components responsible for the blood pressure changes need to be identified.

Diet, Vegetarian↗

PubMed2005

Effect of coffee intake on blood pressure in male habitual alcohol drinkers.

Many cross-sectional epidemiological studies have revealed that alcohol consumption is closely related to an increase in blood pressure, which is known to be associated with an elevated serum gamma-glutamyltransferase (GGT) level, rather than to the volume of alcohol consumed. Since recent studies showed that coffee intake is inversely related to serum GGT, we investigated the effect of coffee on blood pressure in habitual alcohol drinkers. A total of 42 male hypertensive or prehypertensive volunteers who consumed alcohol and coffee daily completed this randomized controlled crossover trial. After a 2-week baseline period, these participants were randomly assigned to either a coffee-drinking group or a non-coffee-drinking group for the first 4 weeks. The situation was then reversed for the next 4 weeks. All participants continued their usual alcohol consumption. Blood pressure was measured once a week and compared between the two groups. After 1 week of coffee intake of more than 3 cups per day, the systolic and diastolic blood pressure began to fall slowly, and cessation of coffee intake raised the blood pressure. Systolic blood pressure was lowered by 7-10 mmHg, and diastolic pressure by 3-7 mmHg in 4 weeks. Alcohol consumption of more than 60 ml per day was maintained and there were no lifestyle changes in the participants of either group throughout the study period. Analyses of urine electrolytes and urea nitrogen indicated that there were no significant dietary changes. In conclusion, coffee intake of more than 3 cups per day in hypertensive and prehypertensive men who regularly consume alcohol lowers blood pressure.

Adult↗

PubMed1988

A randomized placebo controlled, double-blind, crossover trial of transdermal nitroglycerin in stable angina pectoris.

Clinical efficacy of 5 mg per 24 hours transdermal nitroglycerin was studied in a placebo controlled, randomized, double-blind crossover trial, with three days wash-out period at the beginning, in 40 patients with chronic stable angina pectoris during two periods of 14 days. Assessment was carried out by means of a diary method, by the multistage treadmill exercise test, five hours after dosing, and by 24-hour ambulatory ECG recordings. Nitroglycerin patch demonstrated significant improvement of exercise tolerance comparing to placebo, in exercise time to the onset of angina pectoris and ST-segment depression of greater than or equal to 1.0 mm (+45% and +47%), in maximum walking time (+13%), as well as in diminished severity of maximum angina (-38%), in lower maximal ST-segment depression (-32%) and in faster recovery of ST-depression 3 and 6 minutes after the test (-28% and -44%). Nitroglycerin patch showed 33% less angina attacks, mainly severe and moderate, resulting in 37% less sublingual nitroglycerin consumption. A significant fall in the number of ST-segment depression episodes of 1.5 mm or more (-60%) was shown in the 24-hour ECG. All these changes were confirmed to be significant compared to placebo values, at a level of P less than 0.01, by multivariate analysis. This study revealed a positive effect of low dose nitroglycerin patch on improvement of exercise functional capacity and signs of myocardial ischaemia after 14 days of continuous therapy.

Administration, Cutaneous↗

PubMed2002

Modafinil for the treatment of daytime sleepiness in Parkinson's disease: a double-blind, randomized, crossover, placebo-controlled polygraphic trial.

OBJECTIVES: To assess the therapeutic efficacy of modafinil in the treatment of increased daytime sleepiness in patients with Parkinson's disease (PD). DESIGN: Double-blind, randomized, placebo-controlled crossover study with two 2-week treatment blocks, separated by a 2-week washout phase. SETTING: Tertiary Parkinson's disease care center and sleep laboratory at university hospital neurology department. PATIENTS: Fifteen patients with idiopathic PD and daytime sleepiness (Epworth sleepiness score (ESS) 10 or more). INTERVENTIONS: Administration of placebo or modafinil as a single morning dose in a randomized crossover order. The modafinil dose was 100 mg in the first, and 200 mg in the second treatment week. MEASUREMENTS AND RESULTS: At baseline and at the end of each treatment block, sleepiness was evaluated using subjective (perceived sleepiness with the ESS) and objective measures (maintenance of wakefulness test). Twelve patients completed the study (9 male, 3 female; mean age 65.0 +/- 7.6 years, mean disease duration 6.8 +/- 4.1 years). Epworth scores were significantly improved with modafinil (3.42 +/- 3.90) compared to placebo (0.83 +/- 1.99; p = 0.011). Latency to sleep in the maintenance of wakefulness test was not significantly altered by modafinil treatment: 10.9 (3-40)/15.1 (2.5-40) minutes before/after placebo and 12 (2.6-40)/17.8 (4.2-40) minutes before/after modafinil (p = 0.139) [data given as mean +/- standard deviation or median (range)]. CONCLUSIONS: The results of this study suggest that modafinil improves daytime sleepiness in PD patients, at least on a subjective or behavioral level. Modafinil treatment may be considered for EDS in PD patients, in whom otherwise treatable causes of Excessive Daytime Sleepiness (EDS) are absent.

Aged↗

PubMed2000

A randomized double-blind fluvoxamine/placebo crossover trial in pathologic gambling.

BACKGROUND: The study assessed the efficacy and tolerability of the selective serotonin reuptake inhibitor (SSRI) fluvoxamine in the treatment of pathologic gambling (PG). METHODS: A 16-week randomized double-blind crossover design insured that each subject received 8 weeks of fluvoxamine and 8 weeks of a placebo. Fifteen patients entered and 10 subjects, all male, completed the study. RESULTS: Fluvoxamine resulted in a significantly greater percent improvement in overall gambling severity on the PG Clinical Global Impression (PG-CGI) scale. There was a significant drug effect on gambling urge and behavior as measured by the PG modification of the Yale-Brown Obsessive Compulsive Scale and PG-CGI scale improvement scores; however, there was a significant interaction of drug effect with the order of administration of drug and placebo. Post hoc analysis, treating each phase as a separate trial, demonstrated a significant difference between fluvoxamine and the placebo in the second phase of the trial but not in the first. Fluvoxamine side effects were of only mild intensity and consistent with SSRI treatment and were not associated with early withdrawal from the study. CONCLUSIONS: These findings suggest that fluvoxamine is well tolerated and may be effective in the treatment of PG in an acute trial, and that an early placebo effect in PG treatment appears to diminish over time. To confirm this finding and to determine whether improvement persists over an extended period of time, a longer duration parallel-design trial with long-term maintenance follow-up should be conducted in a larger and more diverse PG population.

Adult↗

PubMedDate not supplied

A randomized control trial of a vegetarian diet in the treatment of mild hypertension.

The effect of an ovo-lacto-vegetarian (OLV) diet on blood pressure was assessed in a randomized, controlled, crossover trial in 58 mild untreated hypertensive subjects recruited from the Perth Centre for the 1983 NHF Risk Factor Prevalence Survey. Subjects were randomly allocated to one of three groups; the first maintained their usual diet throughout 12 weeks; the other two were given an OLV diet for either the first or second 6 weeks of the 12-week trial. Introduction of an OLV diet was associated with a significant fall in systolic blood pressure, on average of the order of 5 mmHg, which was unrelated to change in urinary sodium, potassium or body weight. It was concluded that a vegetarian diet may have an adjunctive role in control of mild hypertension, but that in view of likely problems with acceptability those dietary components responsible for the blood pressure differences need to be identified.

Adult↗

PubMed1998

A preliminary placebo-controlled crossover trial of fludrocortisone for chronic fatigue syndrome.

OBJECTIVE: To provide a preliminary assessment of the efficacy and safety of fludrocortisone acetate treatment of chronic fatigue syndrome. DESIGN: A placebo-controlled, double-blind, random-allocation crossover trial of 6 weeks of fludrocortisone. SETTING: An outpatient clinical trials unit. PATIENTS: Twenty-five participants with chronic fatigue syndrome (mean age, 40 years; 19 [76%] women; mean duration of illness, 7.0 years) were recruited from a research and clinic registry. Five patients withdrew from the trial. INTERVENTIONS: All participants were scheduled to receive fludrocortisone acetate (0.1-0.2 mg) or a placebo for 6 weeks in each treatment. MAIN OUTCOME MEASURES: Self-administered questionnaires were completed at the beginning and end of each treatment arm that asked patients to rate the severity of their symptoms on a visual analogue scale. The Medical Outcomes Study 36-Item Short-Form Health Survey, a reaction time test, and a treadmill exercise test were used to assess functional status. Blood pressure, heart rate, and plasma norepinephrine levels were obtained at baseline. Blood pressure and heart rate were recorded at the end of the exercise test and monitored at all subsequent visits. RESULTS: At baseline, the study participants reported symptom severity greater than 5 for most symptoms, and all had evidence of marked functional impairments. No improvement was observed in the severity of any symptom or in any test of function for the 20 participants who completed both arms of the trial. Blood pressure and heart rate readings were unaffected by treatment, and plasma norepinephrine levels did not differ from those of a healthy control group. The incidence of adverse experiences was similar in the fludrocortisone and placebo arms of the trial. CONCLUSION: Low-dose fludrocortisone does not provide sufficient benefit to be evident in a preliminary blinded trial of unselected patients with chronic fatigue syndrome.

Adult↗

PubMed2004

Comparison of patient-controlled and operator-controlled conscious sedation for restorative dentistry.

BACKGROUND AND OBJECTIVE: The use of midazolam for conscious sedation is an accepted method of anxiety control in restorative dentistry. A lack of predictability in its effects requires the dose of midazolam to be adjusted to individual patient's requirements. We determined whether patient-controlled sedation was a suitable alternative to operator-controlled sedation in restorative dentistry. METHODS: A randomized crossover clinical trial involving 35 consecutive patients undergoing similar dental procedures. Patients were randomly given midazolam, administered either by the patient or by the operator at the first visit and the alternative option on the second visit. All patients were ASA I-II and their ages ranged between 20 and 48 yr. Blood pressure, heart rate, oxygen saturation and patient satisfaction were recorded. RESULTS: The onset time and initial dose for sedation were similar with the two methods of administration and the sedation scores and vital signs were satisfactory. In the patient-controlled group the mean total dose of midazolam was 7.9 (+/- 4.2 SD) mg cf. 4.2 (+/- 1.8 SD) mg in the operator-controlled group (P < 0.05). The time to fitness for discharge (15.4 (+/- 11.9 SD) min) was greater in the patient-controlled group cf. the operator-controlled group (8.5 (+/- 9.5 SD) min), P < 0.05. CONCLUSION: This study shows that patient-controlled sedation is a suitable alternative to operator-controlled sedation in the management of anxious dental patients.

Adjuvants, Anesthesia↗

PubMed2003

Treatment of postmastectomy lymphedema with low-level laser therapy: a double blind, placebo-controlled trial.

BACKGROUND: The current study describes the results of a double blind, placebo-controlled, randomized, single crossover trial of the treatment of patients with postmastectomy lymphedema (PML) with low-level laser therapy (LLLT). METHODS: Participants received placebo or one cycle or two cycles of LLLT to the axillary region of their affected arm. They were monitored for reductions in affected limb volume, upper body extracellular tissue fluid distribution, dermal tonometry, and range of limb movement. RESULTS: There was no significant improvement reported immediately after any of the treatments. However, the mean affected limb volume was found to be significantly reduced at 1 month or 3 months of follow-up after 2 cycles of active laser treatment. Approximately 31% of subjects had a clinically significant reduction in the volume of their PML-affected arm (> 200 mLs) approximately 2-3 months after 2 cycles of treatment. There was no significant effect of placebo treatment, or one cycle of laser treatment, on affected limb volume. The extracellular fluid index of the affected and unaffected arms and torso were reported to be significantly reduced at 3 months after 2 cycles of laser therapy, and there was significant softening of the tissues in the affected upper arm. Treatment did not appear to improve range of movement of the affected arm. CONCLUSIONS: Two cycles of laser treatment were found to be effective in reducing the volume of the affected arm, extracellular fluid, and tissue hardness in approximately 33% of patients with postmastectomy lymphedema at 3 months after treatment.

Adult↗

PubMed2000

Failure of intravenous N-acetylcysteine to reduce methemoglobin produced by sodium nitrite in human volunteers: A randomized controlled trial.

STUDY OBJECTIVE: To determine whether intravenous N -acetylcysteine (NAC) produces a clinically significant decline in sodium nitrite-induced methemoglobinemia in human volunteers. METHODS: We conducted a randomized, control crossover trial with each subject serving as his own control. Methemoglobinemia was induced with intravenous sodium nitrite (4 mg/kg) administered over 10 minutes starting at time 0. At time 30 minutes, subjects were randomly assigned to treatment with intravenous NAC for 100 minutes (150 mg/kg over 1 hour followed by 14 mg/kg per hour for 40 minutes) or administration of an equal volume of 5% dextrose in water. Each subject received the alternative treatment after an interval of at least 1 week. Blood methemoglobin concentrations were measured by multiwavelength co-oximetry at time 0, 15, 30, 50, 70, 90, 110, and 130 minutes. Area under the methemoglobin concentration-time curve (AUC) between 30 and 130 minutes was compared between groups using a 2-tailed, paired t test. RESULTS: There were no statistically significant differences in the control and treatment groups with respect to baseline hemoglobin or methemoglobin concentrations, as well as nitrite-induced methemoglobin concentrations at the initiation of treatment (0.85+/-0.06 g/dL, 0.88+/-0.04 g/dL; mean+/-SEM; P =.31). Mean AUC for the control group (77.1+/-5.7 g x min/dL) was significantly lower than the mean AUC for the treatment group (84.5+/-4.7 g x min/dL); P =.01). CONCLUSION: Intravenous NAC failed to enhance methemoglobin reduction in this model.

Acetylcysteine↗

PubMed1997

Balance and vertical impact in sports: role of shoe sole materials.

OBJECTIVE: Athletic shoes and mats are support surface interfaces composed of relatively soft compressible materials designed to protect against injuries occurring in sports through force of vertical impact. Impact remains high with their use because humans land harder with them. We hypothesize that this hard-landing strategy is an attempt by the user to improve stability, by compressing the material to a less destabilizing thinner-stiff variety. We tested this hypothesis by comparing impact and balance on materials consisting of ethyl-vinyl acetate (EVA) foams of varying stiffness, identical to that found in soles of athletic footwear. DESIGN: Randomized-order, crossover trial, controlled comparison, blinded. SETTING: Volunteers were selected from the general community. PARTICIPANTS: A random sample of 12 healthy men from the general population (mean age 30 years, SD +/- 6). Additional selection criteria were absence of disabilities influencing ability to walk, run, and balance, and no history of frequent falls. METHODS: Impact testing and stability measures were performed on the same test day. Ground reaction forces were measured for ten barefoot footfalls. The protocol required stepping forward from perch to surface 4.5 cm below. Stability testing was performed with one-legged standing consisting of placing left foot on top of right for 30 sec, barefoot, eyes open, and gaze straight, with arms to side. Subjects confronted four surface conditions presented in random order: a bare rigid platform, and the platform covered with one of three 2.5-cm-thick materials. RESULTS: Steady state vertical impact was a negative function of interface stiffness, with the softest interface producing the greatest vertical impact, and the stiffest interface the least vertical impact. Vertical impact and stability measures were also negatively related, with the strongest correlation obtained with the softest interface (r = -.87, p < .001). No relation between these variables was obtained for the rigid surface. CONCLUSION: Balance and vertical impact are closely related. This supports the hypothesis that landing hard on soft surfaces is an attempt to transform the interface into a form associated with improved stability. According to these findings, currently available sports shoes and mats are too soft and thick, and should be redesigned to protect the persons using them.

Adult↗

PubMedDate not supplied

A comparative study using prepared and unprepared frozen semen for donor insemination.

The aim of this study was to compare the efficacy of pericervical insemination with unprepared semen With that of intrauterine insemination with prepared donor semen in a prospective, randomized, crossover clinical trial. Fifty-four subsequent patients who qualified for therapeutic donor insemination were randomized to receive alternately either an intrauterine insemination with thawed frozen donor semen, prepared by double wash and swim-up, or pericervical insemination with unprepared thawed frozen donor semen in subsequent treatment cycles, with each patient serving as her own control. Eleven pregnancies ensued from 54 cycles of intrauterine insemination (20.4% per cycle), and 2 pregnancies ensued from 58 cycles of pericervical insemination (3.4% per cycle, p = .005). Five pregnancies ensued during the first treatment cycle (13.2%), 4 during the second treatment cycle (17.4%), 2 during the third (13.2%), 1 during the fourth (7.1%), and 1 after the fourth treatment cycle (4.8%). The significantly better pregnancy rate from intrauterine insemination with prepared semen supports this treatment option. The decrease in pregnancy rate after the fourth treatment cycle confirms the need for alternative therapy after 4 failed cycles of therapeutic donor insemination.

Adolescent↗