Utrogestan (progesterone) / Besins Healthcare - LARVOL DELTA

Cycle-to-cycle Variability of Progesterone in the Endometrium in Patients Undergoing an Euploid Blastocyst Transfer in a Hormone Replacement Therapy (HRT) Cycle (PROMICOFET) (clinicaltrials.gov) - P4 | N=70 | Not yet recruiting | Sponsor: University Hospital, Ghent

New P4 trial

The WinPro trial: A window of opportunity study of endocrine therapy with and without prometrium in postmenopausal women with early stage hormone receptor-positive breast cancer. (ASCO 2025) - P2 | "Patients (pts) were randomised 1:1:1 to letrozole (let) 2.5mg daily, letrozole 2.5mg daily + prometrium (pro) 300mg daily, or tamoxifen (tam) 20mg daily + prometrium 300mg daily for 11-17 days before surgery... The WinPro trial showed that the addition of pro to let in post-menopausal women with ER+, PR+, HER2- breast cancer was safe, reduced hot flushes and led to similar reduction in Ki67 as let alone. Ongoing translational analyses are underway which will examine the changes in gene expression in malignant, immune and stromal cells at sub-cellular resolution and provide further insight into the mechanisms of response and resistance to endocrine therapy."

Clinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • AR • ER • HER-2 • PGR

PLUIM: Progesterone Luteal Support in Unexplained Infertility Management (clinicaltrials.gov) - P3 | N=640 | Not yet recruiting | Sponsor: Simone Broer

New P3 trial • Gynecology • Infertility • Sexual Disorders

Comparable Euploidy and Aneuploidy Patterns Between Utrogestan-Based Progesterone-Primed Ovarian Stimulation and GnRH Antagonist in PGT-M: A Retrospective Matched Cohort Study. (PubMed, Biomedicines) - " Compared with the GnRH-Ant protocol, the Utrogestan-based PPOS protocol required a significantly lower total Gn dose while exhibiting comparable euploidy rate, analogous chromosomal abnormality spectrums, and pregnancy outcomes. The Utrogestan-based PPOS protocol may be a feasible alternative ovarian stimulation strategy in PGT-M cycles."

Journal • Retrospective data

FSD-QUA-2025-27: The impact of ovarian stimulation with hMG on embryo quality in advanced age women. A randomized controlled trial (clinicaltrialsregister.eu) - P4 | N=240 | Not yet recruiting | Sponsor: Santiago Dexeus Font Fundacio Privada

New P4 trial • Infertility • Sexual Disorders

Natural Progesterone for the Treatment of Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=4 | Terminated | Sponsor: Emory University | Trial completion date: Apr 2027 ➔ Mar 2026 | Active, not recruiting ➔ Terminated; Review of Drug Supply

Trial completion date • Trial termination • Brain Cancer • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor

VNTWINC: Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix (clinicaltrials.gov) - P=N/A | N=260 | Recruiting | Sponsor: National Hospital of Obstetrics and Gynecology | Not yet recruiting ➔ Recruiting

Enrollment open

FSD-IEQ-2021-03: The impact of the intensity of ovarian stimulation on embryo quality in predicted suboptimal responders. A randomized controlled trial. (clinicaltrialsregister.eu) - P4 | N=110 | Recruiting | Sponsor: Santiago Dexeus Font Fundacio Privada | Not yet recruiting ➔ Recruiting

Enrollment open • Infertility • Sexual Disorders

The effect of transdermal 17-?-estradiol/progesterone supplementation on glucose regulation in peri- and postmenopausal women with type 1 and type 2 diabetes (clinicaltrialsregister.eu) - P4 | N=48 | Recruiting | Sponsor: Amsterdam UMC Stichting

New P4 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

VNTWINC: Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix (clinicaltrials.gov) - P=N/A | N=260 | Not yet recruiting | Sponsor: National Hospital of Obstetrics and Gynecology | N=200 ➔ 260

Enrollment change

VNTWINC: Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix (clinicaltrials.gov) - P=N/A | N=260 | Not yet recruiting | Sponsor: National Hospital of Obstetrics and Gynecology

New trial

Natural Progesterone for the Treatment of Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=4 | Active, not recruiting | Sponsor: Emory University | Recruiting ➔ Active, not recruiting | N=32 ➔ 4 | Trial completion date: Aug 2026 ➔ Apr 2027 | Trial primary completion date: Aug 2025 ➔ Apr 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor

LUMO: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment (clinicaltrials.gov) - P4 | N=1008 | Recruiting | Sponsor: UMC Utrecht | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2026 ➔ Jul 2027 | Trial primary completion date: Jul 2025 ➔ Dec 2025

Enrollment open • Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

A comparison of progesterone via vaginal oil capsules versus pessaries for luteal phase support in assisted reproduction treatment: a multicentre cohort study of 42 291 cycles. (PubMed, Hum Reprod) - "An appropriately powered randomized controlled trial directly comparing the two drugs, focusing on clinical efficacy, is required to determine if one is superior to the other."

Journal • Infertility

Does luteal phase support in MOH-IUI treatment improve cumulative live birth rates in couples with unexplained subfertility? Study protocol of the LUMO study: a centre, randomised, double-blind, controlled trial with cost-effectiveness analysis. (PubMed, BMJ Open) - P4 | "Participants will start study medication, applying a daily dosage of 2dd 300 mg progesterone (Utrogestan) or 2dd 300 mg placebo in vaginal capsules on the second day after the IUI procedure...It is expected that the results of this trial will be used to draft national guidelines on this issue. The study is registered in the EU CTIS trial register (2022-501534-33-00), the Dutch trial registry (registration number: LTR 24508), ClinicalTrials.gov (NCT05080569) and the WHO registry (universal trial number: U1111-1280-9461)."

Clinical protocol • HEOR • Journal • Infertility

Live birth rates are unrelated to sex-steroid levels on ET day in a dydrogesterone-based 'programmed-ovulatory FET' protocol: a multi-centric prospective cohort study. (PubMed, Hum Reprod Open) - P | "We propose the term 'Programmed-Ovulatory (PO-) FET' for this protocol. The PO-FET protocol enables scheduling the window of implantation, allows ovulation and corpus luteum formation, provides double gestagenic support, and may eliminate the need for control measurements of sex steroids on the day of FET. It allows monitoring of corpus luteum activity during the luteal phase and early pregnancy, is injection-free, and has low drug costs. This protocol needs to be tested in RCTs against other ovulatory FET protocol options, such as the 'NC FET' or 'managed NC FET'."

Journal • Endocrine Disorders

Obesity results in lower integrin expression in women with polycystic ovarian syndrome during the window of implantation. (PubMed, Front Endocrinol (Lausanne)) - P=N/A | "An endometrial tissue sample was collected after 10 days of daily oral micronized progesterone (Utrogestan 200 mg) in the PCOS group. Further research is needed to confirm these results and to identify the potential mechanisms underlying this association. ClinicalTrial.gov, identifier NCT04175002."

Journal • Endocrine Disorders • Genetic Disorders • Obesity • Polycystic Ovary Syndrome • CDH1 • MUC1

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

Enrollment open

Droplet Size Reduction of Self-Emulsifying Drug Delivery System (SEDDS) Using the Hybrid of Medium and Long-Chain Triglycerides. (PubMed, Pharmaceutics) - "The hybrid of MCT&LCT progesterone SEDDS exhibited reduced particle size, enlarged self-emulsifying ranges, and increased drug content in the aqueous phase after lipolysis compared with the conventional mono-MCT or LCT SEDDS. In addition, the bioavailability of progesterone in the MCT&LCT SEDDS formulation was 3.82-fold higher than that of Utrogestan® (a clinical oral administrated product) in a mouse model."

Journal

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