Recombinant LH supplementation in patients with a relative reduction in LH levels during IVF/ICSI cycles: A prospective randomized controlled trial.

PURPOSE: The aim of this study was to assess the use of recombinant luteinizing hormone (rLH) supplementation in patients who experience a reduction in LH concentration during controlled ovarian hyperstimulation (COH) for IVF/ICSI. METHODS: A multi-center prospective randomized controlled trial (RCT) was performed over three years. Two hundred and forty patients aged between 24 and 42 years undergoing IVF/ICSI treatment with a long down regulation (LDR) protocol were recruited. LH was measured on the day FSH was started and again 6days later. 100 patients had a 50% or greater reduction in LH levels and these were randomized to receive either recombinant LH (rLH) supplementation (group 1, n=43) or no additional rLH supplementation (group 2, n=57). Group 1 received rLH 75IU daily from day 7 of FSH stimulation to the day of HCG trigger. RESULTS: There were no differences in either live birth or clinical pregnancy rates per embryo transfer between the two groups (27.8% vs. 37.0%, p=0.39, RR=0.75, 95%CI 0.39-1.44 and 36.1% vs. 43.5% p=0.51, RR=0.84, 95%CI 0.5-1.48, respectively). CONCLUSION: In conclusion the addition of rLH in patients with a relative reduction in serum LH concentration during COH for IVF/ICSI did not improve live birth or clinical pregnancy rates. However the results were not conclusive and further large well-designed RCTs are required to confirm these findings.

Single-arm, observational study of the ease of use of a redesigned pen device to deliver recombinant human follicle-stimulating hormone (follitropin alfa) for assisted reproductive technology treatment.

PURPOSE: Evaluation of patients' ease of use of the redesigned, disposable, ready-to-use follitropin alfa pen during controlled ovarian stimulation for assisted reproductive technology. METHODS: This single-center, observational, open-label, single-arm study recruited infertile normo-ovulatory women (aged 18-45 years). Nurses trained patients to self-administer recombinant human follicle-stimulating hormone daily using the follitropin alfa pen (300 IU, 450 IU, and 900 IU). Before treatment, patients completed Questionnaire A. Following self-administered treatment, on stimulation days 5-6 and 7-8 (within a day of receiving recombinant human chorionic gonadotropin), patients completed Questionnaire B. Nurses completed an ease-of-learning/teaching questionnaire. The primary endpoint was proportion of patients rating the pen as "easy/very easy" to use (Questionnaire B) on the final visit before recombinant human chorionic gonadotropin. Secondary endpoints included: proportion of patients rating the follitropin alfa pen as easy to learn, use, prepare, deliver, and dispose of (Questionnaires A and B). Proportions (95% confidence intervals [CIs]) were provided for primary and secondary endpoints. Adverse events were reported descriptively. RESULTS: Eighty-six patients received recombinant human follicle-stimulating hormone. Of the 72 patients who had completed the overall assessment questions, 66 (91.7%; 95% CI =82.7%-96.9%) found the pen "easy" to use. Also, 70/86 (81.4%) patients "strongly agreed/agreed" that, overall, it was easy to learn how to use the pen; 72/86 (83.7%) "strongly agreed/agreed" that easily understandable, verbal information was provided; and 70/86 (81.4%) were confident about using the pen correctly. In total, 24/26 nurses (92.3%; 95% CI =74.9%-99.1%) rated the pen as easy to use. Clinical pregnancy rate/patient/cycle/embryo transfer was 37%. Twenty-six ovarian hyperstimulation syndrome events were reported (none severe; 16 patients [19%]); of these, 13 occurred at embryo transfer. CONCLUSION: In this observational study, patients had a high acceptance of the redesigned follitropin alfa pen, with most finding it very easy/easy to use. Assisted reproductive technology nurses found the pen very easy/easy to teach.

Elevated progesterone in GnRH agonist down regulated in vitro fertilisation (IVFICSI) cycles reduces live birth rates but not embryo quality.

OBJECTIVE: To assess the impact of pre-hCG elevated progesterone on live birth outcomes during GnRH agonist long down regulated protocol assisted reproduction cycles. DESIGN: Retrospective cohort study. SETTING: Single Centre Private IVF Clinic. PATIENTS: A total of 582 consecutive cycles of IVF/ICSI in 2003. INTERVENTIONS: All patients underwent a long down-regulation protocol, controlled ovarian stimulation and IVF/ICSI. Serum progesterone concentrations were measured just prior to HCG administration. 253 patients were followed to 2009 for outcomes of their frozen embryo cycles. MAIN OUTCOME MEASURE: Live birth rate in fresh and frozen cycles. RESULTS: Patients in the upper quartile pre-hCG progesterone concentration (≥ 5.4 pmol/L) had a higher final estradiol level, more oocytes collected and more usable embryos, when compared to those with lower quartiles. They also had lower live birth rates per cycle started (21.9% vs. 15%, P < 0.05). However, live birth rates from frozen embryo cycles were not significantly different between the groups. CONCLUSIONS: Pre-hCG progesterone elevation leads to lower live birth rates in stimulated IVF cycles. Live birth rates achieved with frozen embryos in the high progesterone cycles suggest, that pre-hCG progesterone elevation negatively affects endometrial receptivity without adversely affecting embryo quality.