title: Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in intrauterine insemination cycles stimulated with gonadotropins: a randomized multicenter study.
abstract: OBJECTIVE
  To evaluate the effect of luteal phase support (LPS) in intrauterine insemination (IUI) cycles stimulated with gonadotropins.
  
  
  METHODS
  Randomized multicenter trial.
  
  
  METHODS
  Academic tertiary care centers and affiliated secondary care centers.
  
  
  METHODS
  Three hundred and ninety-three normo-ovulatory patients, <43 years, with body mass index ≤30 kg/m2, in their first IUI cycle, with at least one patent tube, a normal uterine cavity, and a male partner with total motile sperm count ≥5 million after capacitation.
  
  
  METHODS
  Gonadotropin stimulation, IUI, randomization to LPS using vaginal progesterone gel (n = 202) or no LPS (n = 191).
  
  
  METHODS
  Clinical pregnancy rate, live-birth rate, miscarriage rate, and duration of the luteal phase.
  
  
  RESULTS
  The primary outcome, the clinical pregnancy rate, was not statistically different between the treatment group (16.8%) and the control group (11%) (relative risk [RR] 1.54; 95% confidence interval [CI], 0.89-2.67). Similarly, the secondary outcome, the live-birth rate, was 14.9% in the treatment group and 9.4% in the control group (RR 1.60; 95% CI, 0.89-2.87). The mean duration of the luteal phase was about 2 days longer in the treatment group (16.6 ± 2.2 days) compared with the control group (14.6 ± 2.5 days) (mean difference 2.07; 95% CI, 1.58-2.56).
  
  
  CONCLUSIONS
  Although a trend toward a higher clinical pregnancy rate as well as live-birth rate was observed in the treatment group, the difference with the control group was not statistically significant.
  
  
  BACKGROUND
  NCT01826747.
authors: LUFC-Department of Obstetrics and Gynaecology, University Hospitals Leuven; Department of Development and Regeneration, Leuven, Belgium.
authors: Karen
authors: K
authors: Peeraer
authors: LUFC-Department of Obstetrics and Gynaecology, University Hospitals Leuven; Department of Development and Regeneration, Leuven, Belgium.
authors: Thomas
authors: T
authors: D'Hooghe
authors: Department of Gynaecology-Andrology, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.
authors: Pascale
authors: P
authors: Laurent
authors: Department of Obstetrics and Gynaecology, Imelda Hospitals, Bonheiden, Belgium.
authors: Sofie
authors: S
authors: Pelckmans
authors: Centre de PMA, CHC-Clinique Saint-Vincent, Liège, Belgium.
authors: Annick
authors: A
authors: Delvigne
authors: Leuven Biostatistics and Statistical Bioinformatics Centre, Leuven, Belgium.
authors: Annouschka
authors: A
authors: Laenen
authors: LUFC-Department of Obstetrics and Gynaecology, University Hospitals Leuven; Department of Development and Regeneration, Leuven, Belgium.
authors: Myriam
authors: M
authors: Welkenhuysen
authors: Department of Gynaecology-Andrology, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.
authors: Christine
authors: C
authors: Wyns
authors: LUFC-Department of Obstetrics and Gynaecology, University Hospitals Leuven; Department of Development and Regeneration, Leuven, Belgium. Electronic address: diane.deneubourg@uza.be.
authors: Diane
authors: D
authors: De Neubourg
mesh_terms: D000022:Abortion, Spontaneous / Q000209:etiology; D000282:Administration, Intravaginal; D000328:Adult; D005260:Female; D005298:Fertility; D005300:Fertility Agents, Female / Q000008:administration & dosage*; D005782:Gels; D006062:Gonadotropins / Q000008:administration & dosage*; D006801:Humans; D007246:Infertility / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D007317:Insemination, Artificial, Homologous; D050498:Live Birth; D008183:Luteal Phase / Q000187:drug effects*; D008297:Male; D016017:Odds Ratio; D011247:Pregnancy; D018873:Pregnancy Rate; D011374:Progesterone / Q000008:administration & dosage* / Q000009:adverse effects; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005300:Fertility Agents, Female; D005782:Gels; D006062:Gonadotropins; D011374:Progesterone
keywords: Duration luteal phase; MAR; gonadotropin; intrauterine insemination; luteal phase; pregnancy rate; progesterone; randomized