title: Daily low-dose hCG stimulation during the luteal phase combined with GnRHa triggered IVF cycles without exogenous progesterone: a proof of concept trial.
abstract: OBJECTIVE
  Can the luteal phase support be improved in terms of efficacy, hormonal profiles and convenience as compared with today's standard care?
  
  
  CONCLUSIONS
  Daily low-dose rhCG supplementation in GnRHa triggered IVF cycles can replace the traditional used luteal phase support with exogenous progesterone.
  
  
  BACKGROUND
  A bolus of hCG for final maturation of follicles in connection with COS may induce the risk of OHSS and the luteal phase progesterone levels rise very abruptly in the early luteal phase.
  
  
  METHODS
  This is a proof-of-concept study conducted as a three arm RCT with a total of 93 patients. First patient enrolled in January 2012 and the study finished in January 2014.
  
  
  METHODS
  Normal responder women undergoing IVF/ICSI treatment in a university hospital. One arm served as control, where women followed a standard antagonist protocol. Two study arms were included both having 125 IU hCG daily for luteal phase support without exogenous progesterone after using a GnRHa 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.
  
  
  RESULTS
  The mean serum levels of hCG did not exceeded the normal physiological range of LH activity in any samples. Mid-luteal progesterone 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.
  
  
  CONCLUSIONS
  The number of patients included is limited and conclusions need to be verified in a larger RCT.
  
  
  CONCLUSIONS
  Endogenous production of progesterone may become more attractive as the luteal phase support with levels of LH-like activity only in the physiological range and may, from the patients' point of view, replace inconvenient exogenous progesterone 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.
  
  
  BACKGROUND
  An unrestricted grant from ARTS Biologics made this study possible. None of the authors has any competing interests to declare.
  
  
  BACKGROUND
  ClinicalTrial.gov number: NCT01504139.
  28 December 2011.
authors.affiliation: Laboratory of Reproductive Biology, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Copenhagen, Denmark Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark yding@rh.dk.
authors.forename: Claus Yding
authors.initials: CY
authors.lastname: Andersen
authors.affiliation: The Fertility Clinic, Skive Regional Hospital, Skive, Denmark.
authors.forename: Helle Olesen
authors.initials: HO
authors.lastname: Elbaek
authors.affiliation: The Fertility Clinic, Skive Regional Hospital, Skive, Denmark Faculty of Health, Aarhus University, Aarhus, Denmark.
authors.forename: Birgit
authors.initials: B
authors.lastname: Alsbjerg
authors.affiliation: The Fertility Clinic, Skive Regional Hospital, Skive, Denmark.
authors.forename: Rita Jakubcionyte
authors.initials: RJ
authors.lastname: Laursen
authors.affiliation: The Fertility Clinic, Skive Regional Hospital, Skive, Denmark.
authors.forename: Betina Boel
authors.initials: BB
authors.lastname: Povlsen
authors.affiliation: The Fertility Clinic, Skive Regional Hospital, Skive, Denmark Faculty of Health, Aarhus University, Aarhus, Denmark.
authors.forename: Lise
authors.initials: L
authors.lastname: Thomsen
authors.affiliation: The Fertility Clinic, Skive Regional Hospital, Skive, Denmark Faculty of Health, Aarhus University, Aarhus, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Humaidan
mesh_terms: D000328:Adult; D006063:Chorionic Gonadotropin / Q000008:administration & dosage*; D005260:Female; D005300:Fertility Agents, Female / Q000737:chemistry / Q000627:therapeutic use; D005307:Fertilization in Vitro / Q000379:methods*; D005640:Follicle Stimulating Hormone / Q000378:metabolism; D005498:Follicular Phase / Q000187:drug effects; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000037:antagonists & inhibitors*; D006801:Humans; D007246:Infertility / Q000097:blood / Q000628:therapy; D008183:Luteal Phase / Q000187:drug effects*; D009865:Oocytes / Q000166:cytology; D016471:Ovarian Hyperstimulation Syndrome / Q000209:etiology; D010062:Ovulation Induction; D011247:Pregnancy; D011256:Pregnancy Outcome; D018873:Pregnancy Rate; D011374:Progesterone / Q000097:blood / Q000737:chemistry* / Q000378:metabolism; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D006063:Chorionic Gonadotropin; D005300:Fertility Agents, Female; D007987:Gonadotropin-Releasing Hormone; D011374:Progesterone; C083781:LHRH, Ala(6)-Gly(10)-ethylamide-; D005640:Follicle Stimulating Hormone
keywords: GnRH antagonist; GnRHa trigger; IVF; IVF stimulation; hCG for follicular stimulation; low-dose hCG; luteal phase support