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RECRUITING Phase 4 ClinicalTrials.gov

Progesterone Supplementation After Letrozole-stimulated Insemination

Sponsor: Kirstine Kirkegaard • ClinicalTrials.gov ID: NCT07508657

Registry updated: 2026-09-09
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Description

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.

Interventions

  • Progesterone (Drug)
    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.

Eligibility 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

Conditions

Infertility

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record