dydrogesterone / Generic mfg. - LARVOL DELTA

Swedish physicians' knowledge of and prescribing practices for menopausal hormone therapy: A nationwide cross-sectional survey. (PubMed, Maturitas) - "Differences were observed between responding gynaecologists and GPs in MHT-related practices and knowledge. While GPs reported lower awareness of guidelines and encountered more challenges in prescribing MHT, nearly one-third of gynaecologists also indicated inadequate education in MHT. This study underscores the need for improved guideline awareness and accessible education to support evidence-based menopause care for the expanding midlife female population."

Journal • Gynecology • Obstetrics

Strengthen luteal phase support after dual trigger in sub-optimal ovarian responders: an exploratory, single center, pilot randomized controlled trial (ChiCTR) - P=N/A | N=100 | Recruiting | Sponsor: Guangdong Women and Children Hospital; Guangdong Women and Children Hospital

New trial • Infertility • Sexual Disorders

Pregnancy Rate Is High When the Length of the Luteal Phase During the In Vitro Fertilization Hormone Replacement Cycle Is 144 Hours or More Before Embryo Transfer. (PubMed, Cureus) - "This study clarified two aspects. First, the pregnancy rate in the 144-h group was significantly higher than that in the 132-h group in the analysis of all embryos. Second, the window of implantation may be more important for poor-quality embryos. This study showed that the oral administration of dydrogesterone requires a window of implantation of at least 144 hours."

Journal • Preclinical • Gynecology

Update of the impact of menopausal hormone therapy on breast cancer risk. (PubMed, Eur J Cancer) - "Despite possible changes towards safer MHT prescribing, our data collected largely in early millennium show at least as large BC risk elevations in MHT users as seen in older studies."

Journal • Breast Cancer • Oncology • Solid Tumor

Dydrogesterone is an eligible tool to suppress LH surge in assisted reproduction technologies (ART) cycles. (PubMed, JBRA Assist Reprod) - "DYG is an eligible tool for IVF/ICSI cycles intended to freeze-all and oocyte preservation, embryo banking, and preventing OHSS in patients with high AMH levels."

Journal • Endometriosis • Gynecology • Women's Health

Process optimizations for the synthesis of an intermediate of dydrogesterone. (PubMed, RSC Adv) - "Dydrogesterone (DG) is a potent progesterone drug that can be used to treat almost all progesterone-deficiency in women. The photoinduced reaction time was markedly diminished from 1.5 h to 20 min, while maintaining a bromination yield of over 65%. The optimized process route of intermediate 1 is featured with simple operation, short time, low energy consumption, few by-products, and easy to scale up production, which is critical for enhancing the production efficiency and reducing the environmental impact of DG."

Journal

PPOS vs GnRH: PPOS Protocol Versus GnRH Anatagonist for Expected Normal Responder Patients Undergoing ART : a Randomized Clinical Trial (clinicaltrials.gov) - P3 | N=328 | Completed | Sponsor: Kasr El Aini Hospital

New P3 trial

Kir7.1 is the physiological target for hormones and steroids that regulate uteroplacental function. (PubMed, Sci Adv) - "As a steroid hormone, progesterone is thought to modify uterine and placental morphology by altering gene expression, but another direct mode of action has long been suspected...Kir7.1 is also activated by selective steroids, including those used to prevent premature labor, such as 17-α-hydroxyprogesterone caproate and dydrogesterone, revealing their unexpected mode of action. Our results reveal that Kir7.1 is the molecular target of both endogenous and synthetic steroids that control uterine excitability and placental function. Kir7.1, therefore, is a promising therapeutic target to support healthy pregnancy during mid and late gestation."

Journal

Dydrogesterone alleviates periodontitis in perimenopausal women undergoing periodontal therapy by decreasing inflammation and mediating oral microbiota. (PubMed, Microb Pathog) - "DG enhances the effect of PT on inhibiting inflammatory response in women with periodontitis by mediating oral microbiota."

Journal • Dental Disorders • Inflammation • Periodontitis • Women's Health • IL6 • TNFA

Fewer good-quality cleavage embryos in dydrogesterone-primed ovarian stimulation compared to GnRH antagonist protocol in POSEIDON group 4 patients. (PubMed, J Formos Med Assoc) - "In POSEIDON group 4 patients, the PPOS protocol using dydrogesterone may be associated with lower embryo quality and pregnancy outcomes compared to the GnRH-ant protocol. Further prospective randomized trials are needed to validate these findings."

Journal • Gynecology

Gender-specific effects of dydrogesterone on zebrafish liver metabolism after long-term exposure. (PubMed, Aquat Toxicol) - "To the best of our knowledge, this is the first report on the effects of progestins on body metabolism. Additionally, we find that gender difference is a notable feature of the effects of dydrogesterone on zebrafish."

Journal • Gynecology

PROGESTERONE-PRIMED OVARIAN STIMULATION VERSUS GONADOTROPHIN-RELEASING HORMONE ANTAGONIST in WOMEN with POLYCYSTIC OVARIAN SYNDROME (clinicaltrials.gov) - P=N/A | N=100 | Completed | Sponsor: El Shatby University Hospital for Obstetrics and Gynecology

New trial • Polycystic Ovary Syndrome

Comparison of pregnancy outcome after adding oral or intramuscular progesterone to vaginal progesterone in frozen embryo transfer: A cross-sectional study. (PubMed, Int J Reprod Biomed) - "The chemical pregnancy rates (28.4% vs. 29.9%, p = 0.636), clinical pregnancy rates (25.3% vs. 26.9%, p = 0.604), and ongoing pregnancy rates (21.9% vs. 23.8%, p = 0.525) were lower and miscarriage rates (14.7% vs. 11.7%, p = 0.210) were higher in dydrogesterone group compared to IM progesterone group, although this difference was not statistically significant. Based on the ease of use and similar pregnancy outcomes of oral dydrogesterone, it can potentially replace the daily injections of IM progesterone."

Journal • Observational data

Association of menopausal hormone therapy with risk of cardiovascular disease in Korean women. (PubMed, Eur J Endocrinol) - "There was an increased risk of CVD in MHT users. By regimen, tibolone use was associated with increased risk of CVD, whereas estrogen either alone or in combination with progestogen was not. There was no difference according to the type of estrogen. The type of progestogen seems to modify the results, since dydrogesterone was associated with reduced CVD risk."

Journal • Cardiovascular

No improvement in pregnancy and perinatal outcomes with combined luteal support in modified natural cycle frozen embryo transfer. (PubMed, Front Endocrinol (Lausanne)) - "In the mNC-FET cycle, patients under the age of 35 who chose dydrogesterone alone as a luteal phase support drug exhibited no difference in the live birth rate and perinatal outcome from patients who combined dydrogesterone with progesterone soft capsules or with progesterone vaginal sustained-release gel. However, the outcome still requires confirmation by large-sample prospective studies."

Journal • Retrospective data

The clinical effect of dydrogesterone used for ovarian stimulation in normal-ovulatory women:a randomized controlled dose-finding study of 10 mg versus 20 mg (ChiCTR) - P=N/A | N=342 | Sponsor: Shanghai First Maternity and Infant Hospital; Shanghai First Maternity and Infant Hospital

New trial • Infertility • Sexual Disorders

Oral Dydrogesterone Versus Oral Micronized Progesterone in Threatened Miscarriage: Protocol Paper for a Randomized Controlled Trial. (PubMed, Reprod Fertil) - "Apart from incidence of treatment-emergent adverse events, safety endpoints include changes in complete blood count and results of liver function tests and kidney function tests from baseline to 14 and 24-26 weeks of gestation. Delivery outcomes are exploratory endpoints of the study."

Journal • Pain

Preventive vs. Therapeutic Effects of Shoutai Wan: Maintaining an Acidic Microenvironment at the Maternal-Fetal Interface to Promote Angiogenesis and Minimize Pregnancy Loss in RSA Mice. (PubMed, J Ethnopharmacol) - "In RSA mice, disturbances in aerobic glycolysis at the MFI prevent the maintenance of a stable AME, thus impairing angiogenesis and leading to embryo loss, and STW effectively improve early pregnancy outcomes, and laying the foundation for uterine spiral artery remodeling."

Journal • Preclinical • LDHA • PKM

Birth defects reporting and the use of dydrogesterone: a disproportionality analysis from the World Health Organization pharmacovigilance database (VigiBase). (PubMed, Hum Reprod Open) - "This possible safety signal emphasizes the need for further investigation regarding the fetal safety profile of dydrogesterone."

Adverse events • Clinical • Journal • Genetic Disorders

Unmasking the risk: clinical trials versus real-world evidence on dydrogesterone and birth defects. (PubMed, Hum Reprod Open) - No abstract available

HEOR • Journal • Real-world evidence

EFFECTIVENESS OF COMBINED SURGICAL AND HORMONAL THERAPY IN TREATMENT OF ENDOMETRIOMAS. (PubMed, Georgian Med News) - "After surgical treatment of endometrioma, in cases of using different hormonal medications (Dienogest, COC, Dydrogesterone), the rate of recurrence of endometrioma is significantly lower compared to surgical intervention only, and the effectiveness of different hormonal medications showed no significant difference between groups. Pregnancy rate is significantly higher in Dienogest and Dydrogesterone groups compared to only surgical intervention. In cases of severe pain, treatment with Dienogest and COC is significantly effective compared with Dydrogesterone therapy or surgery alone. In cases of moderate pain all forms of hormone therapy were found to be significantly more effective compared to surgical intervention alone."

Journal • Endometriosis • Gynecology • Pain • Women's Health

Oral dydrogesterone along with vaginal micronized progesterone supplementation for luteal phase support in IVF patients, and its impact on pregnancy and live birth rates: a prospective randomized trial. (PubMed, BMC Pregnancy Childbirth) - "The combination of two different formulations of progesterone (vaginal and oral) for luteal phase support does not improve IVF outcomes when compared to the vaginal route of progesterone administration alone."

Clinical • Journal • Gynecology • Infertility

Efficacy and safety of different progestogens in women with first threatened miscarriage: A network meta-analysis. (PubMed, Int J Gynaecol Obstet) - "However, from the available evidence, there was no statistically significant difference between progestogens and placebo in preterm birth, congenital abnormality, and live birth rate. Oral dydrogesterone was safe and better at reducing miscarriage than vaginal progesterone and placebo for women with first threatened miscarriage, and better at reducing miscarriage compared with placebo for women with threatened miscarriage."

Journal • Retrospective data • Review

Is oral dydrogesterone equivalent to vaginal micronized progesterone for luteal phase support in women receiving oocyte donation? (PubMed, Reprod Biol Endocrinol) - "Oral dydrogesterone seems to be a good alternative to vaginal micronized progesterone for LPS treatment during an artificial cycle, especially in combination with a weekly injection of intramuscular progesterone in the course of oocyte donation."

Journal • Observational data • Retrospective data

Association between first-trimester subchorionic hematoma and pregnancy loss before 20 weeks of gestation in singleton pregnancies. (PubMed, Sci Rep) - "First-trimester SCH is associated with an increased risk of miscarriage before 20 weeks. Large SCHs increase the risk of placental abruption, while dydrogesterone use may reduce miscarriage risk."

Journal • Retrospective data