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Progesterone Supplementation After Letrozole-stimulated Insemination
Sponsor: Kirstine Kirkegaard
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.
Official title: Luteal Phase Support Following Letrozole Treatment in Women Undergoing Intrauterine Insemination: a Multicenter Randomized Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 37 Years
Study Type
INTERVENTIONAL
Enrollment
690
Start Date
2026-04
Completion Date
2030-01
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Progesterone
Vaginal progesterone (Cyclogest) 400 mg administered twice daily starting the day after insemination. Treatment is continued until gestational age 10 weeks in the event of clinical pregnancy or until clinical pregnancy is ruled out.
Locations (4)
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