Serum Progesterone Levels with The Use of Four Different Types of Vaginal Progesterone in Frozen-Thawed Embryo Transfer Cycles and Related Pregnancy Outcomes

Document Type : Original Article


1 Kinutani Women’s Clinic, 4F 8-23 Hondori, Naka-ku, Hiroshima-city, Hiroshima-Prefecture, Japan

2 Center for Integrated Medical Research, Hiroshima University Hospital, Kasumi, Minami-ku, Hiroshima, Japan

3 Katsuki Ladies Clinic, Hiroshima Central Street, Mikawa-cho, Naka-ku, Hiroshima-city, Hiroshima, Japan


Background: Luteal phase support (LPS) is essential for hormone replacement therapy (HRT) for frozen-thawed
embryo transfer (FET). However, the optimal dose and serum progesterone (P4) levels required for pregnancy are
controversial. We attempted to determine the association between pregnancy outcomes and serum P4 levels administered
via vaginal suppository for HRT-FET cycles on embryo transfer day.

Materials and Methods: This was a secondary analysis of the dataset from the EXCULL trial, which prospectively
investigated pregnancy outcomes of four different P4 vaginal suppositories (Lutinus, Utrogestan, Luteum, and
Crinone) for HRT-FET. It was conducted at a private fertility clinic between December 2016 to December 2017.
During this trial, 235 cycles were divided into four groups based on serum P4 values (quartile [Q] 1 group: <7.8
ng/mL; Q2 group: 7.8-10.8 ng/mL; Q3 group: 10.8-13.7 ng/mL; Q4 group: >13.7 ng/mL). We investigated clinical
pregnancy rate (CPR), positive fetal heart rate (FHR), live birth rate (LBR), and miscarriage rate (MR) for each
group. A logistic regression analysis was performed using age, body mass index (BMI), and transferred embryos
as covariates.

Results: Serum P4 values (ng/mL) of each drug were as follows: Lutinus, 13.3 ± 4.9; Utrogestan, 9.3 ± 3.3; Luteum,
13.6 ± 4.2; and Crinone, 8.7 ± 3.2 (mean ± standard deviation, p <0.001).The percentages of Utrogestan and Crinone
were higher in the Q1 group, while the percentages of Lutinus and Luteum were higher in the Q4 group. Nonetheless,
there were no statistical differences between the Q1 and Q4 groups in CPR, FHR, LBR, and MR.

Conclusion: When vaginal P4 was used for FET, although serum P4 levels on transfer day differed based on the drug
that was administered, no relationship was observed between serum progesteronelevels and pregnancy outcomes (Registration
number: UMIN000032997).


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