Patient experience in a randomized trial of a weekly progesterone vaginal ring versus a daily progesterone gel for luteal support after in vitro fertilization.

OBJECTIVE: To assess patient experience and convenience of using progesterone vaginal ring (VR) versus vaginal gel for women requiring luteal phase support during in vitro fertilization (IVF). DESIGN: Post hoc analysis of a prospective, randomized, single-blind, multicenter, phase 3 clinical trial. SETTING: Twenty-two U.S. IVF centers. PATIENT(S): Women undergoing IVF (N = 1,297). INTERVENTION(S): Randomization to weekly VR or daily gel the day after egg retrieval for up to 10 weeks, with fresh embryo transfer IVF per site-specific procedures. MAIN OUTCOME MEASURE(S): Patient satisfaction questionnaire completed at final study visit. RESULT(S): In the women who were taking ≥1 dose of either VR (n = 647) or gel (n = 650), >97% reported that learning to use the formulation, remembering to take it at the correct time, and using it as prescribed was "easy" or "somewhat easy." More VR than gel users reported noninterference with daily activity (93.3% vs. 74.7%, P<.001), sexual comfort (80.3% vs. 67.8%, P<.001), and sexual desire (73.8% vs. 61.8%, P<.001), as well as not being bothered during sexual intercourse (66.9% vs. 39.2%, P<.001). More gel than VR users reported no difficulty with application (97.4% vs. 80.9%, P<.001). Among women who had previously used progesterone during IVF, more VR users than gel users preferred their currently assigned treatment to their previous treatment (91.4% vs. 83.0%, P=.03). CONCLUSION(S): Weekly progesterone VR and daily progesterone gel were easy to use, with limited impact on quality of life. Overall, the VR appeared to interfere less with daily life, social activities, and sexual activity although the gel was less difficult or stressful to apply. CLINICAL TRIAL REGISTRATION NUMBER: NCT00615251.

Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization: a randomized comparative study.

OBJECTIVE: To compare the efficacy and safety of luteal phase support in IVF with a progesterone (P) vaginal ring or gel (VR or VG). DESIGN: Prospective, randomized, single-blind, multicenter, phase III clinical trial (ClinicalTrials.gov identifier: NCT00615251). SETTING: Nineteen private and three academic high-volume U.S. IVF centers. PATIENT(S): One thousand two hundred ninety-seven infertile patients were randomized to a weekly P VR (n = 646) or a daily P 8% VG (n = 651). INTERVENTION(S): IVF was performed per site-specific protocols. The day after egg retrieval, patients were randomized and began VR or VG therapy, which continued for up to 10 weeks' gestation. MAIN OUTCOME MEASURE(S): Clinical pregnancy rates at 8 and 12 weeks of pregnancy; rates of biochemical pregnancy, live birth, spontaneous abortion, ectopic pregnancy, and cycle cancellation; and safety and tolerability were secondary measures. RESULT(S): Clinical pregnancy rates at 8 and 12 weeks were high and comparable between groups: 48.0% for VR and 47.2% for VG at week 8 and 46.4% (VR) and 45.2% (VG) at week 12. Live-birth rates were 45% (VR) and 43% (VG). Adverse event profiles were similar between groups. CONCLUSION(S): The weekly P VR provided similar pregnancy rates to the daily VG, with no major differences in safety.

Vaginal (Crinone 8%) gel vs. intramuscular progesterone in oil for luteal phase support in in vitro fertilization: a large prospective trial.

OBJECTIVE: To compare the efficacy of intravaginal and IMP for luteal phase support in IVF cycles. DESIGN: Prospective trial. SETTING: Tertiary care private practice. PATIENT(S): Women 25-44 years old with infertility necessitating treatment with IVF. From April 1, 2008-April 1, 2009, 511 consecutive patients were enrolled; 474 completed participation, and 37 were excluded for no autologous ET (freeze all, donor recipients, failed fertilization/cleavage). There were no demographic differences between the two treatment groups. INTERVENTION(S): Luteal phase support using either Crinone or P in oil starting 2 days following oocyte retrieval. MAIN OUTCOME MEASURE(S): Pregnancy and delivery rates stratified by patient age. RESULT(S): Overall, patients who received vaginal P had higher pregnancy (70.9% vs. 64.2%) and delivery (51.7% vs. 45.4%) rates than did patients who received IMP. Patients <35 who received vaginal P had significantly higher delivery rates (65.7% vs. 51.1%) than did patients who received IMP. There were no differences, regardless of age, in the rates of biochemical pregnancy, miscarriage, or ectopics. CONCLUSION(S): In younger patients undergoing IVF, support of the luteal phase with Crinone produces significantly higher pregnancy rates than does IMP. Crinone and IMP appear to be equally efficacious in the older patient.

Gynecologic use of Sepraspray Adhesion Barrier for reduction of adhesion development after laparoscopic myomectomy: a pilot study.

OBJECTIVE: To assess the safety and efficacy of Sepraspray Adhesion Barrier (a modified hyaluronic acid and carboxymethylcellulose powder) after laparoscopic surgery, in view of both the high efficacy of Seprafilm Adhesion Barrier in reducing postoperative adhesions after open surgical procedures and the difficulty with laparoscopic delivery. DESIGN: Multicenter, randomized, reviewer-blinded trial. SETTING: Reproductive endocrinology and infertility clinics. PATIENT(S): Women undergoing laparoscopic myomectomy for indications including infertility. INTERVENTION(S): Randomization to treatment with (n = 21) or without (n = 20) Sepraspray Adhesion Barrier. MAIN OUTCOME MEASURE(S): Postoperative adhesions development was assessed at early second-look laparoscopy. Adhesions were scored using the modified American Fertility Society scoring system. RESULT(S): Surgical procedure duration length was 99 versus 102 minutes in the control versus Sepraspray Adhesion Barrier groups, respectively, with the median number of fibroids removed being two in each group and corresponding fibroid weights of 134 ± 103 versus 113 ± 161 g, respectively. Adhesions scores increased in both the control and Sepraspray Adhesion Barrier groups, with larger although nonstatistically significant increases noted in control subjects when evaluating for the anterior uterus, the posterior uterus, and the entire uterus. CONCLUSION(S): Laparoscopic application of Sepraspray Adhesion Barrier after myomectomy in this pilot study was associated with a trend toward a reduction in postoperative adhesion development, as well as an encouraging safety profile. Further evaluation is warranted. CLINICAL TRIAL NUMBER: Sepraspray Adhesion Barrier #NCT00624930.

Effect of prolonged gonadotropin-releasing hormone agonist therapy on the outcome of in vitro fertilization-embryo transfer in patients with endometriosis.

OBJECTIVE: To evaluate the effect of a 3-month course of GnRH agonist administered immediately before IVF-ET in infertile patients with endometriosis. DESIGN: Prospective, randomized trial. SETTING: Three tertiary care assisted reproductive technology programs. PATIENT(S): IVF-ET candidates with surgically confirmed endometriosis. INTERVENTION(S): Twenty-five patients received three courses of a long-acting GnRH agonist, 3.75 mg i.m. every 28 days, followed by standard controlled ovarian hyperstimulation. Twenty-six patients received standard controlled ovarian hyperstimulation with mid-luteal phase GnRH agonist down-regulation or microdose flare regimens. MAIN OUTCOME MEASURE(S): Response to controlled ovarian hyperstimulation, ongoing pregnancy rates per cycle, group implantation rates, and implantation rate per embryo transfer procedure. RESULT(S): The extent of surgically confirmed endometriosis was greater in patients who received the long-acting GnRH regimen for 3 months before IVF-ET. The groups did not differ significantly in terms of dose or duration of gonadotropin stimulation, number of oocytes retrieved, fertilization rate, or number of embryos transferred. Patients who received the long-acting GnRH regimen had significantly higher ongoing pregnancy rates (80% vs. 53.85%) and a trend toward higher implantation rates (42.68% vs. 30.38%). CONCLUSION(S): Prolonged use of GnRH agonist before IVF-ET in patients with endometriosis resulted in significantly higher ongoing pregnancy rates than did standard controlled ovarian hyperstimulation regimens. No deleterious effect on ovarian response was observed.