Patients’ administration preferences: progesterone vaginal insert (Endometrin®) compared to intramuscular progesterone for Luteal phase support

Abstract

BackgroundAdministration of exogenous progesterone for luteal phase support has become a standard of practice. Intramuscular (IM) injections of progesterone in oil (PIO) and vaginal administration of progesterone are the primary routes of administration. This report describes the administration preferences expressed by women with infertility that were given progesterone vaginal insert (PVI) or progesterone in oil injections (PIO) for luteal phase support during fresh IVF cycles.MethodsA questionnaire to assess the tolerability, convenience, and ease of administration of PVI and PIO given for luteal phase support was completed by infertile women diagnosed with PCOS and planning to undergo IVF. The women participated in an open-label study of highly purified human menopausal gonadotropins (HP-hMG) compared with recombinant FSH (rFSH) given for stimulation of ovulation.ResultsMost women commented on the convenience and ease of administration of PVI, while a majority of women who administered IM PIO described experiencing pain. In addition, their partners often indicated that they had experienced at least some anxiety regarding the administration of PIO. The most distinguishing difference between PVI and PIO in this study was the overall patient preference for PVI. Despite the need to administer PVI either twice a day or three times a day, 82.6% of the patients in the PVI group found it “very” or “somewhat convenient” compared with 44.9% of women in the PIO group.ConclusionsThe results of this comprehensive, prospective patient survey, along with findings from other similar reports, suggest that PVI provides an easy-to-use and convenient method for providing the necessary luteal phase support for IVF cycles without the pain and inconvenience of daily IM PIO. Moreover, ongoing pregnancy rates with the well-tolerated PVI were as good as the pregnancy rates with PIO.Trial registrationClinicalTrial.gov, NCT00805935Electronic supplementary materialThe online version of this article (doi:10.1186/1742-4755-11-78) contains supplementary material, which is available to authorized users.

Vitrified blastocyst transfer cycles with the use of only vaginal progesterone replacement with Endometrin have inferior ongoing pregnancy rates: results from the planned interim analysis of a three-arm randomized controlled noninferiority trial

“…Patients undergoing assisted reproduction have significant concerns regarding daily injections of intramuscular P, the most common being injection-associated pain, fear of hitting a blood vessel, and injection of the medication at the wrong site (9). Surveys have indicated that when given the choice, most patients prefer vaginal over intramuscular P administration for a variety of reasons, including greater convenience, ease of use, and less pain (10)(11)(12).…”

Patient experience in a randomized trial of a weekly progesterone vaginal ring versus a daily progesterone gel for luteal support after in vitro fertilization

“…Evidence from a number of clinical trials has demonstrated equivalent efficacy and safety of vaginal progesterone compared with IM progesterone for luteal support in IVF (15)(16)(17). Although vaginal preparations are more convenient and better tolerated than IM progesterone (24,25), some limitations still remain with the current vaginal formulations, including the need for frequent dosing, messiness, and vaginal leakage. It should be noted that vaginal discharge was potentially attributed to gel leakage and thus may have been underreported by vaginal gel users, in contrast with the VR users.…”

“…Relatively few studies on luteal phase support with progesterone have evaluated treatment convenience, satisfaction, and acceptance. Of the studies that have evaluated these end points, most have compared outcomes in patients receiving IM to those receiving vaginal progesterone (24,25,27). The preponderance of evidence from these trials demonstrates that vaginal progesterone is associated with higher patient satisfaction, greater convenience, and less time required to administer the medication (24).…”

A Phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for luteal phase support in in vitro fertilization (Lotus II): results from the Chinese mainland subpopulation

“…For example, although easier for the patient to use, orally administered micronized progesterone is rapidly metabolized by the liver and is associated with drowsiness, flushing, and nausea [10]. On the other hand, intramuscular progesterone administration can result in pain, inflammation, and sterile abscess formation [10,16]. Delivery of micronized progesterone via the vaginal route is most commonly used by IVF practitioners [11]; however, vaginal discomfort, irritation, and discharge are frequently associated with this route of administration [10,17].…”