Utrogestan (progesterone) / Besins Healthcare - LARVOL DELTA

What to expect from a 'standard vaginal progesterone regimen' in hormone replacement therapy frozen embryo transfer (HRT-FET) - a PRISMA review and meta-analysis. (PubMed, Reprod Biomed Online) - "Significant differences were found when comparing Cyclogest (800 mg) with Crinone (180 mg or 270 mg) (P = 0.01); Cyclogest (800 mg) with Utrogestan/Progestan (600 mg or 800 mg) (P = 0.03); and Cyclogest (800 mg) with Lutinus (300 mg) (P = 0.01). However, no significant differences were identified between products with an equivalent daily dose. In conclusion, significant differences in serum progesterone concentration exist between different vaginal progesterone products and dosing regimens, which must be taken into account when performing HRT-FET."

Journal • Retrospective data • Review

Is There a Need for Luteal Support in Modified Natural Cycle Frozen Embryo Transfer Cycles (clinicaltrials.gov) - P4 | N=180 | Not yet recruiting | Sponsor: Dunamenti REK Istenhegyi IVF Center

New P4 trial

Comparison of Pregnancy Rates in Modified Natural Frozen Embryo Transfer (FET) Cycle After Luteal Support with GnRH Agonist Versus Progesterone (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Shaare Zedek Medical Center

New P1 trial

Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients (clinicaltrials.gov) - P4 | N=362 | Terminated | Sponsor: CRG UZ Brussel | Trial completion date: Dec 2025 ➔ Jan 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2025 ➔ Jan 2025; safety

Trial completion date • Trial primary completion date • Trial termination

DECLARED-CT: Effects of Menopausal Hormone and GLP-1 Agonist Therapy on Glucose and Energy Homeostasis in Postmenopausal Women (clinicaltrials.gov) - P=N/A | N=96 | Not yet recruiting | Sponsor: Lia Bally

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients (clinicaltrials.gov) - P4 | N=362 | Active, not recruiting | Sponsor: CRG UZ Brussel | Recruiting ➔ Active, not recruiting | N=522 ➔ 362

Enrollment change • Enrollment closed

Natural Progesterone for the Treatment of Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Emory University | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor • CD14 • CHI3L1 • CRP • FCER2 • MMP9 • PGR

SIGNIFICANCE OF SERUM DAY-3 PROGESTERONE LEVEL AFTER VAGINAL ADMINISTRATION OF DIFFERRENT PROGESTERONE REGIMENS IN HORMONE REPLACEMENT CYCLES FOR FROZEN EMBRYO TRANSFER (ASPIRE 2024) - "Serum P4 level was measured on day 3 after P-only administration.For those patients with P level ≦10 ng/mL, P augmentation with additional P (intramuscular P injection and/or oral dydrogesterone) administration was started from day 4. Conclusions There was a trend in which Utrogestan gave a high serum P level although significant difference did not exist. P augmentation with in-time combination administration of additional P may rescue the FET pregnancy outcome."

Early intrauterine pregnancy with an intrauterine device in place and terminated with spontaneous abortion: A case report. (PubMed, Medicine (Baltimore)) - "The novelty of this case report lies in the rare occurrence of an intrauterine pregnancy with a long-term IUD in place, the challenges posed by the IUD's specific location, and the complex management of threatened abortion in this context. Our case highlights the diagnostic management approach for intrauterine pregnancy with an IUD in place. Furthermore, it explores the impact of IUD location on pregnancy prognosis."

Journal • Long-acting Reversible Contraceptives • Thrombosis

Ovarian response and embryo ploidy following oral micronized progesterone-primed ovarian stimulation versus GnRH antagonist protocol. A prospective study with repeated ovarian stimulation cycles. (PubMed, Hum Reprod) - P=N/A | "In case of a freeze-all protocol, clinicians may safely consider oral micronized progesterone to control the LH surge and patients could benefit from the advantages of a medication of oral administration, with a potentially higher number of oocytes retrieved at a lower cost, without any compromise in embryo ploidy rates."

Journal

Luteal phase support using micronized vaginal progesterone as pessaries or capsules in artificial cycles: is there any difference? (PubMed, Reprod Biomed Online) - "Using MVP pessaries rather than capsules for LPS resulted in significantly fewer patients having suboptimal serum progesterone concentrations on the day of embryo transfer. Consequently, almost 50% fewer patients in the pessary group needed rescue treatment."

Journal

Preparation and formulation of progesterone para-aminobenzoic acid co-crystals with improved dissolution and stability. (PubMed, Eur J Pharm Biopharm) - "Tablets containing co-crystal were produced then compared to the Utrogestan® soft gel capsule formulation through a dissolution experiment. PROG-PABA tablets showed a substantial increase in dissolution over the course of the experiment with over 30× the amount of PROG dissolved at the 3-hour time point. This co-crystal shows positive implications for developing an improved oral PROG formulation."

Journal

Comparison Between Vaginal Pessary and Progestogen in Twin Pregnancy With Short Cervical Length (clinicaltrials.gov) - P3 | N=142 | Completed | Sponsor: National University of Malaysia | Not yet recruiting ➔ Completed | N=310 ➔ 142

Enrollment change • Trial completion

Verify the Safety and Effectiveness of the Cerclage Pessary in Prevention and Treatment of High-risk Preterm Pregnancy (clinicaltrials.gov) - P=N/A | N=300 | Not yet recruiting | Sponsor: QH Medical Technology Ltd. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date

Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients (clinicaltrials.gov) - P4 | N=522 | Recruiting | Sponsor: CRG UZ Brussel | Trial completion date: Oct 2022 ➔ Dec 2025 | Trial primary completion date: Jun 2021 ➔ Sep 2025

Trial completion date • Trial primary completion date

Association between serum progesterone levels on the day of frozen-thawed embryo transfer and pregnancy outcomes after artificial endometrial preparation. (PubMed, BMC Pregnancy Childbirth) - "The present study suggests that the serum P levels on the day of embryo transfer (ET) do not correlate with the likelihood of a LB in artificial cycles when using a combination of oral dydrogesterone and vaginal progesterone for luteal phase support."

Journal

Prog_STIM: Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles. (clinicaltrials.gov) - P=N/A | N=44 | Completed | Sponsor: Institut Universitari Dexeus | Recruiting ➔ Completed

Trial completion • Infertility • Sexual Disorders

Endometrial Heparin-Binding Epidermal Growth Factor Gene Expression and Hormone Level Changes in Implantation Window of Obese Women with Polycystic Ovarian Syndrome. (PubMed, Biomedicines) - "Different patterns of hormonal levels and Hb-EGF expression levels were seen between the studied groups. However, further in vitro and in vivo studies are needed to investigate the mechanism underlying the changes in FSH, LH/FSH ratio, DHEA and Hb-EGF expression in PCOS after progesterone treatment."

Journal • Endocrine Disorders • Infertility • Obesity • Polycystic Ovary Syndrome • Sexual Disorders • EGF • HBEGF

Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor (clinicaltrials.gov) - P4 | N=129 | Completed | Sponsor: HaEmek Medical Center, Israel | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Feb 2023

Trial completion • Trial completion date

The effect of frozen embryo transfer regimen on the association between serum progesterone and live birth: a multicentre prospective cohort study (ProFET). (PubMed, Hum Reprod Open) - P=N/A | "Our results corroborate existing evidence suggesting that lower serum progesterone levels hinder FET success. However, the relationship between serum progesterone and the probability of live birth appears to be non-linear in women receiving exclusively subcutaneous progesterone, suggesting that in this subgroup of women, high serum progesterone may also be detrimental to treatment success."

Journal

Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor (clinicaltrials.gov) - P4 | N=140 | Active, not recruiting | Sponsor: HaEmek Medical Center, Israel | Unknown status ➔ Active, not recruiting | Trial completion date: Dec 2021 ➔ Dec 2023 | Trial primary completion date: Jun 2021 ➔ Jan 2023

Enrollment closed • Trial completion date • Trial primary completion date

To determine the pre-test probability of malignancy for women bleeding on “New” HRT – Are we over or under-investigating? (ESGE 2022) - "Women on Utrogestan are over-represented in referrals made before 3 and 6 months after commencing HRT adding further pressure to already overstretched waiting lists and clinician anxiety. Large studies are needed to establish the prevalence of bleeding with Utrogestan for endometrial protection, the pre-test probability of malignant disease and the risk of invasive investigation compared with alternatives."

Clinical • Anesthesia • Gynecology • Mood Disorders • Oncology • Psychiatry

The effect of polymorphisms in FSHR gene on late follicular phase progesterone and estradiol serum levels in predicted normoresponders. (PubMed, Hum Reprod) - P=N/A | "Based on our results, FSHR SNPs rs6165, rs6166 and rs1394205 do not have any clinically significant impact neither on late follicular phase serum progesterone nor on estradiol levels in predicted normal responders. These findings add to the controversy in the literature regarding the impact of individual genetic susceptibility in response to OS in this population."

Journal

GnRH Agonist for Luteal Phase Support. (clinicaltrials.gov) - P=N/A | N=150 | Active, not recruiting | Sponsor: Shaare Zedek Medical Center

New trial

Impact of micronised progesterone and medroxyprogesterone acetate in combination with transdermal oestradiol on cardiovascular markers in women diagnosed with premature ovarian insufficiency or an early menopause: a randomised pilot trial. (PubMed, Maturitas) - "The positive changes in traditional markers were not reflected in the cardiogenic biomarker, cfPWV, which has demonstrated a higher positive predictive value for cardiovascular events than traditional measurements."

Combination therapy • Journal • Cardiovascular • Women's Health