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Effect of nifedipine administration before embryo transfer on reproductive outcome in ICSI cycles, a double-blind control trial study

  • Gynecologic Endocrinology and Reproductive Medicine
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

Nifedipine is a calcium channel blocker with smooth muscle relaxing properties. This study set out to investigate the efficacy of nifedipine administered orally before embryo transfer (ET) on the improvement of the intracytoplasmic sperm injection (ICSI) outcome. This randomized, double-blind, comparator-controlled, was carried out between 2019 and 2020 in the infertility center of Babol, Iran. 200 women candidates for ICSI and recipients of frozen-thawed ET aged 18–40 years were randomly assigned in the ratio 1:1 to an intervention group that received nifedipine 20 mg tablets orally 30 min before ET (n = 100) or to a group of placebo (n = 100). A randomization center in Babol University of Medical Science used computer-generated numbers to allocate treatments. The allocation treatment was blind to the participants, the sonographer of endometer monitoring, the staff of the ICSI laboratory, and the outcome assessor. The primary analysis was based on the intention-to-treat principle done on 200 participants, (n = 100), comparing chemical pregnancy rates in the two comparing groups at 14 days’ follow-up after ET. Implantation rate and clinical pregnancy were considered secondary outcomes.

Result

200 participants were analyzed. There is no significant difference in the number of oocytes and the quality of embryos in the nifedipine and placebo groups. Despite a numerical increase in the rate of chemical pregnancy, there were no statistical differences in the study group versus the comparison group (24% vs 14%, P = 0.1, rate ratio 0.88, 95% CI 0.77 to 1.01), respectively. Also, no significant increase in clinical pregnancy was found compared with the placebo (17% vs 8%, P = 0.26, rate ratio 0.90, 0.81 to 1.00).

Conclusion

Nifedipine administered orally 30 min before embryo transfer did not improve the chemical pregnancy rate, and clinical pregnancy rate in infertile women undergoing ICSI. This trial has been registered on the Iranian Clinical Trials Registration Site (IRCT) with the number IRCT20180417039338N3.

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Notes

  1. Blood Pressure.

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Funding

Health Research Institute of Babol University of Medical Science supported us financially.

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Authors and Affiliations

  1. Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Science, Shahid Salehi Ave, 31, Babol, 47191-73599, Iran

    Fatemeh Basirat, Sedighe Esmaeilzadeh, Zahra Basirat, Faeze Ghofrani & Masoumeh Golsorkhtabaramiri

Authors
  1. Fatemeh Basirat
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  2. Sedighe Esmaeilzadeh
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  3. Zahra Basirat
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  4. Faeze Ghofrani
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  5. Masoumeh Golsorkhtabaramiri
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Contributions

FAB: project development, data collection, data analysis. ZAB: manuscript writing/editing, project development. SEE: project development, data collection. FAG: data collection. MAG: manuscript writing, data analysis.

Corresponding author

Correspondence to Zahra Basirat.

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Conflict of interest

The authors declare no conflict of interest.

Ethical approval

Approval ID: IR.mubabol.HRI.REC.1397, Date: 2018–12-16, Approved by: Health Research institute, Babol University of Medical Science.

Informed consent

The consent form related to clinical trial study that given by Health Research Institute of Babol University of Medical Science, filled out by all participants. All information taken from the study were coded to protect each subject’s name. No names or other identifying information were used when discussing or reporting data. The investigator safely kept all files and data collected in a secured locked cabinet in the principal investigators office. Once the data were fully analyzed, it were destroyed.

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Basirat, F., Esmaeilzadeh, S., Basirat, Z. et al. Effect of nifedipine administration before embryo transfer on reproductive outcome in ICSI cycles, a double-blind control trial study. Arch Gynecol Obstet 309, 2891–2896 (2024). https://doi.org/10.1007/s00404-023-07362-5

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  • DOI: https://doi.org/10.1007/s00404-023-07362-5

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