Progesterone Supplementation After Letrozole-stimulated Insemination (NCT07508657) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Progesterone Supplementation After Letrozole-stimulated Insemination
Denmark690 participantsStarted 2026-04
Plain-language summary
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-stimulated IUI cycles.
Who can participate
Age range
18 Years – 37 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.