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Progesterone Supplementation After Letrozole-stimulated Insemination

NCT07508657 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 690

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Kirstine Kirkegaard

    lead OTHER

Principal Investigators

  • Kirstine Kirkegaard, Clinical Associate Professor · University Clinic for Fertility, Horsens Regional Hospital, Central Denmark Region

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-06-30
Completion
2030-01-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07508657 on ClinicalTrials.gov