Daily low-dose hCG stimulation during the luteal phase combined with @entity4397 triggered IVF cycles without exogenous XXXX : a proof of concept trial.

@entity1 @entity14563 @entity1420 @entity4397 @entity6862
STUDY QUESTION: Can the luteal phase support be improved in terms of efficacy, hormonal profiles and convenience as compared with today's standard care? SUMMARY ANSWER: Daily low-dose rhCG supplementation in @entity4397 triggered IVF cycles can replace the traditional used luteal phase support with exogenous @entity1420 . WHAT IS KNOWN ALREADY: A bolus of hCG for final maturation of follicles in connection with @entity6862 may induce the risk of @entity14563 and the luteal phase @entity1420 levels rise very abruptly in the early luteal phase. STUDY DESIGN, SIZE, DURATION: This is a proof-of-concept study conducted as a three arm RCT with a total of 93 @entity1 . First @entity1 enrolled in January 2012 and the study finished in January 2014. @entity1 /MATERIALS, SETTING, METHODS: Normal responder @entity1 undergoing IVF/ICSI treatment in a university hospital. One arm served as control, where @entity1 followed a standard antagonist protocol. Two study arms were included both having 125 IU hCG daily for luteal phase support without exogenous @entity1420 after using a @entity4397 trigger for ovulation induction. In both study arms exogenous FSH was stopped on stimulation day 6 and replaced by exogenous hCG that was initiated on either stimulation day 2 or day 6. Blood samples were obtained on the day of ovulation induction, on the day of oocyte pickup (OPU) and day OPU + 7. MAIN RESULTS AND THE ROLE OF CHANCE: The mean serum levels of hCG did not exceeded the normal physiological range of LH activity in any samples. Mid-luteal @entity1420 levels were significantly higher in the two study groups receiving daily low-dose hCG for luteal phase support as compared with the control group (control group: 177    27 nmol/l; study group 1: 334    42 nmol/l; study group 2: 277    27 nmol/l; (mean    SEM). No differences in reproductive outcome were seen between groups. LIMITATIONS, REASONS FOR CAUTION: The number of @entity1 included is limited and conclusions need to be verified in a larger RCT. WIDER IMPLICATIONS OF THE FINDINGS: Endogenous production of @entity1420 may become more attractive as the luteal phase support with levels of LH-like activity only in the physiological range and may, from the @entity1 ' point of view, replace inconvenient exogenous @entity1420 preparation. Further hCG may reduce the cost of stimulation and may collectively be used for stimulation of the follicular phase, ovulation induction and for luteal phase support. STUDY FUNDING/COMPETING INTERESTS: An unrestricted grant from ARTS Biologics made this study possible. None of the authors has any competing interests to declare. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov number: NCT01504139. TRIAL REGISTRATION DATE: 28 December 2011.
