Progesterone Supplementation After Letrozole-stimulated Insemination

Sponsor
Kirstine Kirkegaard
Study ID
NCT07508657
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Infertility

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 37 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Apr 2, 2026
Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
690 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    Vaginal progesterone luteal phase support. Progesterone is administered as Cyclogest 400 mg twice daily form the day after insemination. Treatment is continued until gestational age 10 weeks in the event of clinical pregnancy, or until pregnancy is ruled out in women who do not achieve a clinical pregnancy.
  • No Intervention: Comparison
    No luteal phase support will be administered after insemination, reflecting current standard treatment.

Primary Outcome Measure

Clinical Pregnancy Rate [ Time Frame: Gestational age 7-9 weeks ]

Central Contacts

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