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Not yet recruiting NCT07508657

Progesterone Supplementation After Letrozole-stimulated Insemination

Phase IV Interventional Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Progesterone.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: 18 years — 37 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Luteal Phase Support Following Letrozole Treatment in Women Undergoing Intrauterine Insemination: a Multicenter Randomized Trial

Overview

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

  • 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.

Primary outcome measures

  • Clinical Pregnancy Rate [Time frame: Gestational age 7-9 weeks]
Secondary outcome measures (7)
  • Live Birth Rate [Time frame: At the time of delivery]
  • Biochemical Pregnancy Rate [Time frame: 14-17 days after intrauterine insemination]
  • Early Pregnancy Loss [Time frame: Up to 10 weeks of gestation]
  • Fetal miscarriage [Time frame: From 10 weeks of gestation to delivery]
  • Obstetric outcomes [Time frame: At time of delivery]
  • Perinatal outcomes [Time frame: At time of delivery]
  • Hormone levels [Time frame: Time of insemination and mid-luteal phase (approximately 7-9 days after insemination).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 4 centers
  • Copenhagen University Hospital - Rigshospitalet. Department of Gynecology, Fertility and O — Copenhagen
  • The Fertility Clinic, Herlev Hospital — Herlev
  • University Clinic for Fertility, Horsens Regional Hospital, Central Denmark Region — Horsens
  • The Fertility Clinic, Hvidovre Hospital — Hvidovre

Identifiers

NCT: NCT07508657 · 05112025 · 2025-524327-53-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗