Efficacy of patient self-administered recombinant human chorionic gonadotropin (RHCG) is comparable to nurse administred RHCG in ovulation induction cycles
Infertility treatment requires patients to overcome a variety of physical, emotional, and financial obstacles. Often, patients express anxiety over self-administration of medications, including subcutaneous recombinant hCG (rHCG). Midluteal rise in progesterone (P4) levels to >3ng/dL suggest evidence of ovulation, and of R9ng/dL of adequate luteinization. Many patients express concern over whether they will adequately be able to self-administer medication. The study sought to determine if the rate and adequacy of ovulatory response is comparable whether a patient or a nurse administers the medication.
Design
Retrospective cohort study
Materials and Methods
The study included patients who underwent ovulation induction cycles using either Letrozole or Clomiphene Citrate who had midluteal P4 levels measured on day +3 to day +10 following rhCG injection from March 2002 to March 2017. The primary outcome was rise in P4 (R9ng/dL). Patients were segregated into two groups based on who administered rhCG (Nurse-administered (RN); Self-administration (PT)). Secondary outcomes were clinical and biochemical pregnancy rates between the study groups and between patients with a P4 < or R9ng/dL. Chi-square test, t-test, and regression analysis were performed using SAS. Significance was confirmed with p<0.05.
Results
A total of 672 cycles met the inclusion criteria. All patient demographic, follicle size and count, and drug administration characteristics were included in the analysis. Regardless of whether a nurse or the patient herself administered rhCG, no significant difference was observed between midluteal P4 levels in patients (p=0.16). A post hoc power analysis revealed adequate sample size for RN vs PT administration group comparison. No differences were observed between pregnancy outcomes in RN vs PT administration groups. Midluteal P4 levels did significantly differ among cycles that resulted in pregnancy (p<0.0001) (both chemical and clinical), dominant follicle size (p=0.002), and number of follicles >18mm on day of trigger (p<0.0001). Ovulation rates following rhCG were greater than 95% across both groups.
Conclusions
The rise in midluteal P4 is not diminished by self-adminstration of rhCG following ovulation induction with either Clomiphene Citrate or Letrozole. Due to the frequency of office visits, balancing work and family obligations is often difficult for patients undergoing fertility treatments. Patients can be reassured of their ability to properly administer medication at home; a finding that could reduce the amount of office visits and anxiety regarding self-administration.
To review the use of hCG and to describe the clinical benefit of recombinant hCG (r-hCG) based on the published results of prospective, randomized studies. Review of published articles. Tertiary infertility care center.None.None. Oocyte number and quality, luteal phase progesterone, pregnancy and OHSS rate, and local tolerability. The published data consistently show that single doses of 250 microg r-hCG and 5,000 IU urinary (u)-hCG produce similar clinical outcomes when used in infertility treatment cycles for timed intercourse, IUI, and IVF in terms of the number of oocytes retrieved, number of mature oocytes harvested, and fertilization and pregnancy rates attained. Single doses of 10,000 IU u-hCG also gave results comparable to single doses of 250 microg r-hCG. P levels in the midluteal phase were significantly higher with the use of r-hCG compared with u-hCG, and local injection site adverse effects were significantly less frequent, demonstrating the higher purity of the recombinant product. A single 500-microg dose of r-hCG led to a higher rate of ovarian hyperstimulation syndrome compared with a 250-microg dose, with no significant improvement in pregnancy rates.A single dose of 250 microg r-hCG was at least as effective as single doses of 5,000 or 10,000 IU u-hCG but offered the advantages associated with use of a recombinant product: local injection site adverse effects were significantly less frequent with r-hCG than with u-hCG.
To determine whether hMG offers an advantage over clomiphene citrate (CC) in achieving pregnancy after IUI with husband's sperm. Randomized prospective trial. Infertility patients in a university teaching hospital. PATIENT(S): Fifty-eight women under 39 years old undergoing ovulation induction before IUI. INTERVENTION(S): The women were assigned randomly to one of two treatment groups. Patients in group I (CCHH) received CC for the first two cycles and hMG for the last two cycles. Patients in group II (HHCC) received hMG for the first two cycles and CC for the last two cycles. MAIN OUTCOME MEASURE(S): Cycle fecundity rates for the two treatment modalities were compared statistically with use of life-table analysis. RESULT(S): Of the 174 cycles studied, overall cycle fecundity rate was 11.11 (9 of 81 cycles) in the CCHH group and 10.75 (10 of 93 cycles) in the HHCC group. The difference was not statistically significant. The cycle fecundity rate was 14.44% (13 of 90 cycles) for cycles with CC and 7.14% (6 of 84) with hMG. The difference was not statistically significant. CONCLUSION(S): These data suggest that CC is an effective alternative to hMG in the population examined.
To compare subcutaneous (SC) and intramuscular (IM) hCG administration and their association with body mass index (BMI) in women undergoing IVF-ET using hMG and ICSI. Prospective, randomized controlled trial. Private infertility clinic. PATIENT(S): Twenty-one ovulatory women, 29-39 years, were enrolled. Treatment of one patient who failed to respond to hMG was canceled. INTERVENTION(S): A standard IVF-ET treatment plan using an initial dose of 300 U of hMG was followed. Patients were randomly assigned to receive 10,000 IU hCG, either IM in the gluteal region or SC in the lower abdomen. Exactly 12 hours later, serum for hCG determination was obtained. All oocytes were fertilized using ICSI technology. MAIN OUTCOME MEASURE(S): Human chorionic gonadotropin levels 12 hours after injection, BMI, and oocyte maturity. RESULT(S): No significant differences in hCG levels were found, with mean levels of 225 +/- 24 mIU/mL for SC injection versus 213 +/- 26 mIU/mL for IM injection. No differences were observed in the percentage of mature oocytes. A significant negative correlation was found between BMI and hCG levels in all patients, regardless of route of administration. CONCLUSION(S): The highest levels of hCG were measured in women with the lowest BMI. Patients' body size, rather than route of hCG delivery, appears to determine circulating levels of hCG.
To confirm that hCG levels in follicular fluid and serum would be comparable between i.m. and s.c. administration of purified hCG. In a prospective study, serum and follicular fluid levels of hCG after an i.m. or s.c. injection of 10,000 IU of hCG were evaluated 36 hours after injection, that is, at the time of oocyte retrieval. This study was carried out in a university-affiliated IVF program. PATIENT(S): Forty women undergoing oocyte retrieval were entered into the study at the time of egg retrieval, that is, 36 hours after hCG administration. INTERVENTION(S): S.c. or i.m. injection of hCG. MAIN OUTCOME MEASURE(S): Serum and follicular fluid concentrations of hCG were evaluated 36 hours after injection at the time of oocyte retrieval. RESULT(S): There was a significantly higher serum hCG level in the s.c. group (348.6 +/- 98 IU/L) vs. the i.m. group (259.0 +/- 115 IU/L) and a significantly higher follicular fluid hCG level in the s.c. vs. the i.m. group (233.5 +/- 85 vs. 143.4 +/- 134 IU/L). CONCLUSION(S): After purified hCG administration via the s.c. route, both serum and follicular fluid levels are greater compared with the i.m. route.