Dosing Characteristics of Recombinant Human Luteinizing Hormone or Human Menopausal Gonadotrophin-Derived LH Activity in Patients Undergoing Ovarian Stimulation: A German Fertility Database Study

Gynecol Obstet Invest. 2023;88(4):214-225. doi: 10.1159/000530360. Epub 2023 Jun 27.

Abstract

Objectives: The aim of the study was to evaluate dosing of recombinant human luteinizing hormone (r-hLH) or human menopausal gonadotrophin (hMG)-derived medications with LH activity in ovarian stimulation (OS) cycles for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI).

Design: A non-interventional study was performed to analyse data from the German RecDate database (January 2007-December 2011).

Participants/materials, setting, methods: Starting/total r-hLH/hMG dose, OS duration/cycle number, r-hLH/hMG initiation day (first day of administration), and population/cycle characteristics were assessed in women (≥18 years) undergoing OS for IVF/ICSI using r-hLH or hMG-derived medications (excluding corifollitropin alfa, clomiphene citrate, letrozole, mini/micro-dose human chorionic gonadotrophin, and urofollitropin alone). Data were summarized descriptively.

Results: 67,858 identified cycles utilized medications containing r-hLH (10,749), hMG (56,432), or both (677). Mean (standard deviation) OS duration with r-hLH and hMG was 10.1 (4.43) and 9.8 (6.16) days, respectively. Median (25th-75th percentile) r-hLH starting dose (75.0 [75.0-150.0] IU) was consistent across patients regardless of age, infertility diagnosis, or gonadotrophin-releasing hormone (GnRH) protocol. Median (25th-75th percentile) hMG-derived LH activity starting dose was 225.0 (150.0-300.0) IU, regardless of GnRH protocol, but was lower in women aged <35 years and those with ovulation disorders/polycystic ovary syndrome. Median (25th-75th percentile) total dose for r-hLH (750.0 [337.5-1,125.0] IU) and hMG-derived LH activity (1,575.0 [750.0-2,625.0] IU) varied according to patients' age, infertility diagnosis, cycle number, and r-hLH/hMG initiation day. GnRH antagonist use resulted in a numerically higher median total hMG-derived LH activity dose than GnRH agonist use.

Limitations: The data used in this study were taken from electronic medical records relating to a specific timeframe (2007-2011) and therefore may not accurately reflect current clinical practice; however, it is likely that the differences between the two compounds would be maintained. Additionally, secondary data sources may suffer from uniformity and quality issues.

Conclusions: The standard of care for OS cycles is described with respect to IVF/ICSI treatment including an LH component in Germany during the specified timeframe.

Keywords: Human menopausal gonadotrophin; Luteinizing hormone; Ovarian stimulation; Real-world data; Recombinant human luteinizing hormone.

MeSH terms

  • Female
  • Fertility
  • Fertilization in Vitro / methods
  • Gonadotropin-Releasing Hormone
  • Humans
  • Infertility*
  • Luteinizing Hormone
  • Male
  • Menopause
  • Menotropins / therapeutic use
  • Ovulation Induction / methods
  • Semen*

Substances

  • Luteinizing Hormone
  • Menotropins
  • Gonadotropin-Releasing Hormone

Grants and funding

Funding for this study was provided by Merck (CrossRef Funder ID: 10.13039/100009945). Medical writing support in the preparation of this manuscript was funded by Merck KGaA, Darmstadt, Germany.