P–411 Does subcutaneous progesterone (SC-P) administration eliminate the necessity of serum progesterone level monitoring in frozen embryo transfer (FET) cycles?. (6th August 2021)

• Record Type: Journal Article
• Authors: Boynukalin, F K; Abalı, R; Gultomruk, M; Demir, B; Yarkiner, Z; Karlikaya, G; Bahceci, M
• Is Part Of: Human reproduction. Volume 36:Supplement 1(2021)
• Publication Date: 2021-08-06
• Subjects: Human reproduction -- Periodicals; 618
• DOI: 10.1093/humrep/deab130.410
• Languages: English
• ISSNs: 0268-1161

Abstract

Abstract: Study question: Does SC-P provide similar ongoing pregnancy rates (OPRs) as intramuscular progesterone(IM-P) in hormone replacement therapy (HRT)-FET cycles and do serum progesterone (P) levels on FET day effect on pregnancy outcome? Summary answer: SC-P administration had similar OPR compared to IM-P in HRT-FET cycles. In SC-P group embryo transfer(ET) day P found to be insignificant factor for outcome. What is known already: Different P routes can be used in HRT-FET cycles such as vaginal P, IM-P and recently SC-P. Only retrospective studies evaluated the comparison of SC-P with other routes in HRT-FET cycles. Here, we assessed prospectively whether SC-P is effective for HRT-FET cycles. Previous studies reported that serum P levels on ET day after vaginal P administration clinical outcomes were closely correlated. The correlation between serum P after IM-P administration and clinical outcomes were conflicting. In addition, there is lack of data on the serum P levels after SC-P administration. Serum P levels on ET day were evaluated in this study. Study design, size, duration: This prospective cohort study was performed between July 1-October 31 2020, enrolled 224 patients scheduled for HRT-FET cycles with SC-P(25 mg twice daily) or IM-P(50 mg once daily). The route of P was decided according to the patient's eligibility to hospital. First FET cycle was included after freeze-all cycles for each patients. Female age>35, PGT-A cycles, cleavage ET, >1 ET, patients with uterine pathology and hydrosalpinx, FET with surplus embryos, endometrial thickness<7mm were excluded. Participants/materials, setting, methods: Female age ≤ 35 years old with a triple-layer endometrium >7 mm underwent transfer of single blastocysts after the first ET after freeze-all cycles. The indications for freeze-all were ovarian hyperstimuation syndrome and trigger day P level>1.5 ng/ml. 224 patients were eligible for study; 133 in SC-P group and 91 in IM-P group.The primary endpoint was the ongoing pregnancy rate (OPR) beyond pregnancy week 12. Main results and the role of chance: The demographic, cycle, embryologic characteristics were similar between groups. The median circulating P levels on the day of ET were 19.92(15.195–27.255)ng/ ml and 21(16.48–28)ng/ml in the SC-P and IM-P groups, (p = 0.786). The clinical pregnancy rates [86/133(64.7%) vs 57/91(62.6%);p=0.757], miscarriage rates [21/86(24.4%) vs 10/57(17.5%) ;p=0.329], and OPR [65/133 (48.9%) vs 47/91(51.6%); p = 0.683] were comparable between the SC-P and IM-P. Binary logistic regression was performed for ongoing pregnancy as the dependent factor blastocyst morphology was found to be the only significant independent prognostic factor (p = 0.006), whereas the route of P was insignificant. In the SC-P and IM-P groups, the effect of ET day P levels were divided into quartiles(Q) to evaluate the effect on ongoing pregnancy. In SC-P group OPR were similar in four Q [Q1:33.3%(11/33), Q2:50%(17/34), Q3:60.6%(20/33), Q4:51.5%(17/33) (p = 0.1)].For IM-P group; Q1 had a significantly reduced OPR than Q2, Q3, Q4. [26.1%(6/23), 65.2%(15/23), 54.5%(12/22) and 60.9%(14/23), p = 0.031]. Logistic regression analysis for OP was performed separately in SC-P group and IM-P group. Although in SC-P group, ET day P levels was not found to be a significant factor, in IM-P ET day P level was found to be an independent factor for OP in IM-P group (Q1vs Q2+Q3+Q4; OR: 8, 178 95% CI: [1.387–48.223] p:0.02). . Limitations, reasons for caution: Although this study has the advantage of being prospective and in a homogenous study population, randomized controlled trials are warranted to evaluate the effectiveness of SC-P to other routes of P. Extrapolation to unselected populations of this study is needed. Wider implications of the findings: Assignment of threshold of serum P on the day of ET for HRT-FET cycles to optimize outcomes is critical for every route of P. Regarding these results, individual luteal phase for HRT-FET cycles can improve IVF outcome. Trial registration number: None