OBJECTIVE: To evaluate the relative efficacy of a new system for fallopian tube sperm perfusion in comparison with standard IUI in controlled ovarian hyperstimulation (COH) cycles. DESIGN: Prospective randomized trial. SETTING: Ovulation induction program of a tertiary outpatient care center, Hôpital Antoine Béclère, Clamart, France. PATIENTS: We studied 74 infertile women aged 20 to 38 years undergoing 100 cycles of COH from December 1993 to May 1994 only excluding cases of age > 38 years, obstructed or severely damaged fallopian tubes, E2 levels per mature follicle < 250 pg/mL (conversion factor to SI unit, 3.671) on the day of hCG administration, spontaneous LH surge, and cases of marked sperm abnormalities. INTERVENTIONS:Controlled ovarian hyperstimulation was achieved using three types of ovarian stimulation protocols: clomiphene citrate (CC) and hMG (n = 35). hMG alone (n = 35) or GnRH agonist and FSH and hMG (n = 30). Thirty-six hours after hCG administration, patients were assigned randomly to either IUI (group A, n = 50) or fallopian tube sperm perfusion (group B, n = 50). Intrauterine insemination was performed with 0.2 mL of sperm suspension according to a standard technique. Fallopian tube sperm perfusion was performed using a simple and reliable system that ensures a good cervical seal and allows to a pressurized injection of 4 mL of sperm suspension. MAIN OUTCOME MEASURES: Feasibility of the fallopian tube sperm perfusion method, clinical pregnancy (presence of gestational sac with heart beats at 6 weeks of amenorrhea), and ongoing pregnancy rates (PRs) (> 12 weeks of amenorrhea), incidence of complications (multiple pregnancies and ovarian hyperstimulation syndrome [OHSS]). RESULTS: Overall, the new fallopian tube sperm perfusion system was simple to handle and well tolerated by patients. In group A, we observed 10 clinical pregnancies (20% per cycle) of which 7 were ongoing (14%). In group B, 20 clinical pregnancies (40% per cycle) of which 17 ongoing pregnancies (34%) were obtained. These differences were statistically significant. The prevalence of twin and three or more sac pregnancies was similar in the two groups (3/10 and 0/10, respectively, in group A, and 5/20 and 2/20, respectively, in group B). No case of moderate or severe OHSS was observed in this series. CONCLUSIONS: Our results indicate that the new system for fallopian tube sperm perfusion is not only simple and reliable but also may lead to PRs twice as high as standard IUI in COH cycles.
RCT Entities:
OBJECTIVE: To evaluate the relative efficacy of a new system for fallopian tube sperm perfusion in comparison with standard IUI in controlled ovarian hyperstimulation (COH) cycles. DESIGN: Prospective randomized trial. SETTING: Ovulation induction program of a tertiary outpatient care center, Hôpital Antoine Béclère, Clamart, France. PATIENTS: We studied 74 infertile women aged 20 to 38 years undergoing 100 cycles of COH from December 1993 to May 1994 only excluding cases of age > 38 years, obstructed or severely damaged fallopian tubes, E2 levels per mature follicle < 250 pg/mL (conversion factor to SI unit, 3.671) on the day of hCG administration, spontaneous LH surge, and cases of marked sperm abnormalities. INTERVENTIONS: Controlled ovarian hyperstimulation was achieved using three types of ovarian stimulation protocols: clomiphene citrate (CC) and hMG (n = 35). hMG alone (n = 35) or GnRH agonist and FSH and hMG (n = 30). Thirty-six hours after hCG administration, patients were assigned randomly to either IUI (group A, n = 50) or fallopian tube sperm perfusion (group B, n = 50). Intrauterine insemination was performed with 0.2 mL of sperm suspension according to a standard technique. Fallopian tube sperm perfusion was performed using a simple and reliable system that ensures a good cervical seal and allows to a pressurized injection of 4 mL of sperm suspension. MAIN OUTCOME MEASURES: Feasibility of the fallopian tube sperm perfusion method, clinical pregnancy (presence of gestational sac with heart beats at 6 weeks of amenorrhea), and ongoing pregnancy rates (PRs) (> 12 weeks of amenorrhea), incidence of complications (multiple pregnancies and ovarian hyperstimulation syndrome [OHSS]). RESULTS: Overall, the new fallopian tube sperm perfusion system was simple to handle and well tolerated by patients. In group A, we observed 10 clinical pregnancies (20% per cycle) of which 7 were ongoing (14%). In group B, 20 clinical pregnancies (40% per cycle) of which 17 ongoing pregnancies (34%) were obtained. These differences were statistically significant. The prevalence of twin and three or more sac pregnancies was similar in the two groups (3/10 and 0/10, respectively, in group A, and 5/20 and 2/20, respectively, in group B). No case of moderate or severe OHSS was observed in this series. CONCLUSIONS: Our results indicate that the new system for fallopian tube sperm perfusion is not only simple and reliable but also may lead to PRs twice as high as standard IUI in COH cycles.
Authors: Jorge Rodriguez-Purata; Laura Latre; Marta Ballester; Clara González-Llagostera; Ignacio Rodríguez; Iñaki Gonzalez-Foruria; Rosario Buxaderas; Francisca Martinez; Pedro N Barri; Buenaventura Coroleu Journal: Hum Reprod Open Date: 2018-02-15