The effect of luteal-phase support with vaginal progesterone on pregnancy rates in gonadotropin and clomiphene citrate/intra-uterine insemination cycles in unexplained infertility: A prospective randomised study

Abstract

The purpose of this study is to analyse the effect of luteal-phase support on pregnancy rates in gonadotropin + intra-uterine insemination (Gn/IUI) and clomiphene citrate (CC) +IUI (CC/IUI) cycles in patients with unexplained infertility. Equal numbers of patients were recruited in two treatment arms (CC/IUI and Gn/IUI) (n = 100, n = 100, respectively). In each group, 50 patients received vaginal progesterone for 14 days (Crinone 8% vaginal gel, 90 mg per day) for luteal-phase support from the day after IUI and continued until menstruation or the 10th week of gestation if pregnant. There were 29 clinical pregnancies among 200 patients. Pregnancy rates were 12% in CC/IUI cycles, 10% in luteal-phase-supported CC/IUI cycles 16% in Gn/IUI cycles and 20% in luteal-phase-supported Gn/IUI cycles. Although pregnancy rates were higher in Gn/IUI cycles compared to CC/IUI cycles, luteal-phase support did not significantly affect the pregnancy rates in both groups. This study implies that luteal-phase support with progesterone has no pronounced beneficial effect on pregnancy rates in either CC/IUI or Gn/IUI cycles in patients with unexplained infertility.

Progesterone luteal support after ovulation induction and intrauterine insemination: an updated systematic review and meta-analysis

“…A total of 31 abstracts were identified, and six full-text articles were reviewed, all of which met full inclusion criteria (17)(18)(19)(20)(21)(22). By combining these six trials with the five studies previously identified in our 2013 meta-analysis ( 13), this updated meta-analysis of 11 RCTs comprised 2,842 patients and 4,065 OI-IUI cycles (17-27) (Supplemental Fig.…”

“…Four of these studies specified the use of recombinant FSH for ovulation induction (20,22,23,25), and one study did not list a specific medication beyond describing the use of urinary or recombinant gonadotropins (19). One study described two treatment arms, one of which consisted of patients who received only recombinant FSH and a second arm that included patients who underwent stimulation with CC (21). One trial used either hMG alone or CC plus 2 days of hMG (17).…”

“…Ovulation triggering was performed with either 5,000 IU or 10,000 IU of hCG in eight studies (17,18,20,(23)(24)(25)(26)(27). Two trials used 6,500 IU of recombinant hCG (19,21), and one study used recombinant hCG but did not specify dose (22). All studies used vaginal routes of P luteal support, with variation in the type and dose of P as well as therapy duration (Table 1).…”

“…The randomization process was clearly described in all studies. Six trials used computergenerated randomization sequences in a non-crossover design (18,20,21,23,24,26). Two trials also used computer-generated randomization sequence; however, patients were randomized to their first cycle of treatment and then either alternated treatment groups in each subsequent treatment cycle (25) or were re-randomized in subsequent treatment cycles (19).…”

“…None of the studies documented blinding of outcomes data. Nine trials adequately reported on the flow of patients through the study and were at low risk of incomplete data reporting (17,(19)(20)(21)(22)(23)(24)(25)(26). One study disclosed an author's affiliation with a pharmaceutical company (22).…”