A provider survey assessing fetal impact of CFTR modulator use in males with CF during assisted and unassisted reproduction and partner pregnancy

J Cyst Fibros. 2024 May;23(3):412-416. doi: 10.1016/j.jcf.2023.10.022. Epub 2023 Nov 11.

Abstract

Background: Most males with cystic fibrosis (mwCF) are infertile but with CF transmembrane conductance regulator (CFTR) modulator-conferred benefits, more are utilizing assisted reproductive technologies (ART). Administration of normal human doses of modulators in animal reproductive models caused no genotoxicity; no human data exists. Potential health decline following modulator discontinuation makes the decision to withhold therapy during reproduction challenging.

Methods: From August-October 2021, international CF clinicians completed an anonymous questionnaire regarding mwCF who used modulators during reproduction.

Results: We received 42 surveys for mwCF with partner pregnancies. Forty of 42 mwCF utilized ART; 35 continued modulators during sperm retrieval and 40/42 during partner pregnancy. One of four males who discontinued modulators experienced clinical deterioration. First trimester miscarriages occurred in 11.9 % of partner pregnancies. No congenital anomalies were reported.

Conclusions: Use of CFTR modulators during reproduction and partner pregnancy in mwCF did not result in a higher-than-expected miscarriage rate nor congenital anomalies.

Keywords: Assisted reproduction; CFTR; Conception; Cystic fibrosis; Modulators.

MeSH terms

  • Abortion, Spontaneous / epidemiology
  • Adult
  • Cystic Fibrosis Transmembrane Conductance Regulator* / genetics
  • Cystic Fibrosis* / drug therapy
  • Female
  • Humans
  • Infertility, Male / etiology
  • Male
  • Pregnancy
  • Reproductive Techniques, Assisted*
  • Surveys and Questionnaires

Substances

  • Cystic Fibrosis Transmembrane Conductance Regulator