Anupa Nandi1, Priya Bhide2, Richard Hooper3, Anil Gudi2, Amit Shah2, Khalid Khan3, Roy Homburg2. 1. Fertility Unit, Homerton University Hospital, London, United Kingdom. Electronic address: anupa.nandi@gmail.com. 2. Fertility Unit, Homerton University Hospital, London, United Kingdom. 3. Women's Health Research Unit, The Blizard Institute, London, United Kingdom.
Abstract
OBJECTIVE: To evaluate the best first line management option for the treatment of unexplained subfertility-controlled ovarian hyperstimulation (COH) with gonadotropins and IUI or IVF. DESIGN: Randomized controlled trial. SETTING: Single center trial in a tertiary referral unit. PATIENT(S): Couples with unexplained subfertility. INTERVENTION(S): Couples were randomized to receive either three cycles of IUI + COH or one cycle of IVF. MAIN OUTCOME MEASURE(S): Singleton pregnancy rate (PR) per couple. RESULT(S): A total of 207 couples were randomly assigned to three cycles of IUI + COH (n = 101) or one cycle of IVF (n = 106). There were 25 (24.7%) singleton live births for the IUI + COH group and 33 (31.1%) for the IVF group (relative risk, 1.3; 95% confidence interval [CI] 0.81-1.96) with an absolute risk difference of 6.4% (95% CI -5.8% to 18.6%). The multiple pregnancies per live birth were 4 (13.8%) for the IUI + COH group and 3 (8.3%) for the IVF group (relative risk, 0.6; 95% CI 0.14-2.4). There were no cases of ovarian hyperstimulation syndrome (OHSS) in the IUI group and three cases of OHSS (3.7%) in the IVF group. There were 17 live births from spontaneous conception in between treatment cycles (8.2%). CONCLUSION(S): The singleton live birth rate with one cycle of IVF was not significantly different than three cycles of IUI + COH. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN43430382. Crown
RCT Entities:
OBJECTIVE: To evaluate the best first line management option for the treatment of unexplained subfertility-controlled ovarian hyperstimulation (COH) with gonadotropins and IUI or IVF. DESIGN: Randomized controlled trial. SETTING: Single center trial in a tertiary referral unit. PATIENT(S): Couples with unexplained subfertility. INTERVENTION(S): Couples were randomized to receive either three cycles of IUI + COH or one cycle of IVF. MAIN OUTCOME MEASURE(S): Singleton pregnancy rate (PR) per couple. RESULT(S): A total of 207 couples were randomly assigned to three cycles of IUI + COH (n = 101) or one cycle of IVF (n = 106). There were 25 (24.7%) singleton live births for the IUI + COH group and 33 (31.1%) for the IVF group (relative risk, 1.3; 95% confidence interval [CI] 0.81-1.96) with an absolute risk difference of 6.4% (95% CI -5.8% to 18.6%). The multiple pregnancies per live birth were 4 (13.8%) for the IUI + COH group and 3 (8.3%) for the IVF group (relative risk, 0.6; 95% CI 0.14-2.4). There were no cases of ovarian hyperstimulation syndrome (OHSS) in the IUI group and three cases of OHSS (3.7%) in the IVF group. There were 17 live births from spontaneous conception in between treatment cycles (8.2%). CONCLUSION(S): The singleton live birth rate with one cycle of IVF was not significantly different than three cycles of IUI + COH. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN43430382. Crown
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