A review of conventional and sustained-release formulations of oral natural micronized progesterone in obstetric indications

Abstract

Background Exogenous progesterone is a treatment option for obstetric indications associated with reduced progesterone activity. Oral natural micronized progesterone (NMP) is effective, although it requires multiple daily doses and may cause adverse events due to its active metabolites. A sustained-release formulation of NMP (NMP-SR) has been developed to overcome the limitations of conventional oral NMP. Methods This narrative review examines the available evidence for oral NMP and NMP-SR in several obstetric indications of interest. Results Literature searches identified 17 studies of oral NMP (luteal phase support during assisted reproduction, prevention of threatened miscarriage, prevention of preterm delivery), and clinical studies supporting use of NMP-SR (luteal phase support during intrauterine insemination, maintenance of high-risk pregnancy). Oral NMP was effective for luteal phase support during in vitro fertilization and intrauterine insemination, prevention of threatened miscarriage, and prevention of preterm delivery. NMP-SR was comparable to dydrogesterone for luteal phase support during intrauterine insemination and effectively maintained high-risk pregnancies. Oral NMP-SR was well tolerated. Conclusions By releasing progesterone gradually and circumventing first-pass metabolism, NMP-SR elicits the desired therapeutic effect with benefits over conventional oral NMP in terms of bioavailability, once-daily dosing and improved tolerability. Oral NMP-SR appears to be a valuable option for treating obstetric conditions associated with insufficient progesterone exposure.

Marvel drug for infertility!!

“…14 In the present study no side effects like drowsiness, nausea and vomitings were identified with dydrogesterone and sustained release micronized hydroxy-progesterone which was comparable to studies done by Salehpour et al(2013)., 15 and Wagh et al (2021). 16 Similar results were obtained in an RCT done by Herman Tournaye et al and others. 11 In the present study the results obtained proved the use of dydrogesterone for luteal support is beneficial as data depicted in Table 3.…”

Comparison Between Single Oral Dydrogesterone versus Vaginal Progesterone gel plus Oral Dydrogesterone Clinical Outcome within the First in GnRH Antagonist Fresh Embryo Transfer Cycle: A Retrospective Analysis

“…Oral progesterone is very convenient for the patients. However, oral medication was previously thought to be ineffective in luteal phase support for ART because of its poor bioavailability, rapid prehepatic and hepatic metabolism, and systemic adverse effects such as somnolence, dizziness, and headache [9]. It is very important to nd an effective, well-tolerated, and easy-to-operate luteal phase support administration.…”

Cervical Length and Perinatal Outcome

“…While in women that are at low risk of preterm birth and with the estimated risk of preterm birth in this population to be 4% (singleton pregnancies, absence of history of preterm birth in previous pregnancy), a correlation appears to exist between preterm birth and cervical length, measured by ultrasound between 19th and 24th week of pregnancy. In these singleton low-risk pregnancies it has been found that a cervical length of 15 mm occupies the third percentile, having a sensitivity of 8.2% and a specificity of 99.7% in the prediction of preterm birth below 32 weeks of gestation, with a cervical length of 25 mm corresponding to the tenth percentile in pregnancies of 16-24 weeks of gestation (threshold below which the cervix is described as "short") [5][6][7][8][9][10].…”