Subcutaneous progesterone is evaluated better by patients performing embryo transfer in substituted cycles. Results of a randomized controlled trial

To compare patient satisfaction using subcutaneous progesterone (Prolutex, 25 mg daily) with micronized vaginal progesterone (Progeffik 200 mg t.i.d.) for substituted cycles in oocyte recipients. Single centre, blinded for the investigator, controlled, prospective, randomized trial. Pilot study. Trial registration number: EudraCT: 2014-004784-20; ClinicalTrials: NCT02363127. Over 18 months, 120 oocyte recipients were randomized on the day of egg retrieval of the donor based on a computer-generated randomization list to receive 25 mg daily SP or VP (200 mg tid daily) Patients included fulfilled medical and legal criteria for oocyte donation and followed the standard preparation protocol using transdermal estradiol. Randomization took place the day of the oocyte retrieval from the donor and in all the cases the embryo transfer was performed at the blastocyst stage. Patient satisfaction to the administration of progesterone was evaluated by means of a 5-point (1 to 5) numeric rating scale about comfortability, lack of hygiene, concern about the loss of medication, interference with sexual relations, safety and global evaluation of the treatment. The questionnaire was completed at the visit of the pregnancy test (ten days after the embryo transfer) and just before stopping the medication at twelve weeks of gestation. For the statistical analysis, t-test or ANOVA test were used for continuous variables and Fisher test for categorical variables. Both groups were homogeneous in terms of age (40,2 years SP; 40,0 years VP p=0,784), BMI (23,9 Kg/m2 SP; 22,8 Kg/m2 VP p=0,074). Ongoing pregnancy rate at 12 weeks of gestation was 33,3% in the SP group and 50,0% in the VP group this difference was no significant (p=0,086). Comfortability results of the day of the pregnancy test are shown in table 1. Rating of overall assessment of the progesterone used was 4,84 for the SP vs 4,18 for VP(p<0,0001).Tabled 1Table 1SubcuteneousVaginalpHas the management of progesterone treatment been uncomfortable?1,431,780,0346Have you experienced a lack of hygiene following the administration of progesterone?1,022,220,0001Have you been concerned about drug losses following the administration of progesterone?1,002,020,0001Has the administration of progesterone allowed you to perform your daily activities in a normal way?4,714,190,0036Has the administration of progesterone interfered with sex?1,091,700,0006Progesterone medication and therapy has provided security used in treatment?4,484,000,0121What is your overall assessment of the progesterone drug you have used?4,283,640,0002 Open table in a new tab Subcutaneous progesterone was evaluated better than vaginal progesterone in patients with substituted cycle after 10 days of treatment and, in the case of evolutive pregnancy, at the 12th week of gestation. Efforts must be made to find the protocol to maximise the efficacy of subcutaneous progesterone preserving its comfortability.