Efficacy of four vaginal progesterones for luteal phase support in frozen-thawed embryo transfer cycles: A randomized clinical trial

Reiko Shiba, Masayuki Kinutani, Shinichiro Okano, Reo Kawano, Yuko Kikkawa, Reiko Shiba, Masayuki Kinutani, Shinichiro Okano, Reo Kawano, Yuko Kikkawa

Abstract

Purpose: To investigate the efficacy of four vaginal progesterones, Lutinus, Utrogestan, Luteum, and Crinone, as luteal phase support (LPS) in frozen-thawed embryo transfer (Frozen-ET) cycles.

Methods: Patients undergoing autologous Frozen-ET of one cleavage-stage embryo or one blastocyst. Two hundred fifty-nine Frozen-ET cycles were randomized to four groups for LPS: Lutinus, Utrogestan, Luteum, and Crinone. The clinical pregnancy rate (CPR), fetal heartbeat rate (FHR), and miscarriage rate (MR) were analyzed using the Mann-Whitney or Kruskal-Wallis test and Fisher exact test.

Results: Two hundred thirty-five Frozen-ET cycles were analyzed: 63 cycles in the Lutinus group, 60 in the Utrogestan group, 56 in the Luteum group, and 56 in the Crinone group. No significant differences were observed between the four groups in CPR (Lutinus, Utrogestan, Luteum, and Crinone: 34.9%, 33.3%, 37.5%, and 35.7%, respectively; P = .976), FHR (26.9%, 31.6%, 30.3%, and 25.0%, respectively; P = .857), and MR (31.8%, 10.0%, 19.0%, and 30.0%, respectively; P = .306). Multivariate logistic regression analysis also revealed that there were no statistically significant differences between the four groups with regard to CPR, FHR, and MR.

Conclusion: There was no clinically significant difference in pregnancy outcomes between the four vaginal progesterone groups for LPS in Frozen-ET cycles.

Keywords: clinical pregnancy; frozen‐thawed embryo transfer; luteal phase support; randomized clinical trial; vaginal progesterone.

Conflict of interest statement

None. Human rights statement and informed consent: This study was approved by the Ethical Committee of Kinutani Women's Clinic (ethical review number 2016‐1110‐1) and registered in the UMIN Clinical Trials Registry (name of the trial register: exploratory test to investigate the CPR between four vaginal progesterones: Lutinus vaginal tablet (300 mg/d), Utrogestan vaginal capsule (600 mg/d), Luteum vaginal suppository (800 mg/d), and Crinone vaginal gel (90 mg/d), registration number: UMIN000032997). All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and its later amendments. Informed consent was obtained from all patients included in the study. Animal studies: This article does not contain any study with animal participants that have been performed by any of the authors.

© 2019 The Authors. Reproductive Medicine and Biology published by John Wiley & Sons Australia, Ltd on behalf of Japan Society for Reproductive Medicine.

Figures

Figure 1
Figure 1
CONSORT flow diagram of the study. The diagram shows participant flow through the study, including patient eligibility, reasons for exclusion, treatment group allocation, loss to follow‐up, and number of cycles included in the final analysis

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