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Progesterone Supplementation After Letrozole-stimulated Insemination

RecruitingPhase 4Ages 18 Years - 37 YearsFemaleKirstine Kirkegaard
NCT07508657 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This trial aims to investigate whether luteal phase support improves the chance of pregnancy in women undergoing intrauterine insemination (IUI) following ovarian stimulation with letrozole. In this randomized clinical trial, 690 women undergoing letrozole-stimulated IUI at four public fertility clinics in Denmark will be randomly allocated to one of two groups: * Vaginal progesterone from the day after insemination (Cyclogest 400 mg twice daily) * No luteal phase support, reflecting current clinical practice All participants will undergo a standard letrozole-stimulated IUI treatment, including ultrasound monitoring, ovulation triggering, and insemination. Blood samples will be collected on the day of insemination and 7-9 days after insemination to measure hormone levels. The results of this trial will provide further insight into the role of progesterone support in letrozole-stimula

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18-37 years * Scheduled for IUI with homologous or donor sperm * Undergoing mild ovarian stimulation with letrozole * Ability to provide written informed consent Exclusion Criteria: * Age \> 37 years * Anovulation due to hypogonadotropic hypogonadism * Known hypersensitivity to progesterone or hard fat listed as an excipient in the Summary of Product Characteristics (SmPC) for Cyclogest. * Known or suspected progesterone-sensitive malignant tumours * Porphyria * Known missed abortion or ectopic pregnancy * Active arterial or venous thromboembolism, severe thrombophlebitis, or a history of these conditions * Severe hepatic dysfunction or liver disease * Inability to speak or understand Danish sufficiently to comprehend oral and written study information
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What it tests

  • Progesterone
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Where

4 sites
Copenhagen University Hospital - Rigshospitalet. Department of Gynecology, Fertility and Obstetrics
Copenhagen, Denmark
The Fertility Clinic, Herlev Hospital
Herlev, Denmark
University Clinic for Fertility, Horsens Regional Hospital, Central Denmark Region
Horsens, Denmark
The Fertility Clinic, Hvidovre Hospital
Hvidovre, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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