Progesterone support after letrozole-stimulated IUI
Official title: Luteal Phase Support Following Letrozole Treatment in Women Undergoing Intrauterine Insemination: a Multicenter Randomized Trial
Run by University of Aarhus · NCT07508657 · Data updated 2026-11-12
This trial tests whether adding vaginal progesterone after letrozole-stimulated intrauterine insemination helps more people become pregnant.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 37 Years |
| Sex | Women only |
| Enrollment | 690 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 4 sites (Copenhagen and 3 other locations) |
| Status | Recruiting |
| Started | August 28, 2026 |
| Main results expected | June 2029 |
| Study ends | January 2030 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07508657 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–37 years planning IUI with either partner or donor sperm and undergoing mild ovarian stimulation with letrozole.
✕Probably not a fit
Individuals not responding to luteal phase support or for whom progesterone is contraindicated may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized phase 4 trial, 690 individuals undergoing letrozole-stimulated IUI at four Danish fertility clinics are assigned to receive vaginal progesterone starting the day after insemination or to receive no luteal phase support. All participants have standard monitoring and insemination procedures, with hormone measurements taken on insemination day and 7–9 days later. The study aims to clarify the role of progesterone in improving pregnancy outcomes in letrozole-stimulated IUI cycles. Results could inform clinical practice on luteal phase support in this setting.
Why it matters
Potential benefit: If successful, the approach could increase pregnancy rates for people undergoing letrozole-stimulated IUI.
How similar studies have gone: Prior research on luteal phase support in IUI has shown mixed results; this large randomized trial adds robust data to the question.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University Clinic for Fertility, Horsens Regional Hospital, Central Denmark Region
Horsens, Denmark Recruiting -
Copenhagen University Hospital - Rigshospitalet. Department of Gynecology, Fertility and Obstetrics
Copenhagen, Denmark Not yet recruiting -
The Fertility Clinic, Herlev Hospital
Herlev, Denmark Not yet recruiting -
The Fertility Clinic, Hvidovre Hospital
Hvidovre, Denmark Not yet recruiting
Study contacts
- Principal investigator: Kirstine Kirkegaard, Clinical Associate Professor — University Clinic for Fertility, Horsens Regional Hospital, Central Denmark Region
- Study coordinator: Kirstine Kirkegaard, Clinical Associate Professor
- Email: fertilitet@horsens.rm.dk
- Phone: +4578426562
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.