Infertility
Conditions
Keywords
Luteal phase support, Intrauterine insemination, Letrozole, Vaginal progesterone, Randomized clinical trial, Ovulation induction
Brief 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.
Interventions
DRUGProgesterone
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
Kirstine Kirkegaard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessment is performed by a physician masked to treatment allocation. Participants and treating clinical staff are not masked.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | Gestational age 7-9 weeks | Defined as an ultrasonographically visible foetal heartbeat at 7-9 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Live Birth Rate | At the time of delivery | Defined as the birth of one or more living infants after a pregnancy of GA ≥ 22 weeks |
| Biochemical Pregnancy Rate | 14-17 days after intrauterine insemination | Defined as a positive serum or urine β-hCG test 14-17 days after intrauterine insemination |
| Early Pregnancy Loss | Up to 10 weeks of gestation | Defined as intrauterine pregnancy loss before 10 weeks of gestational age |
| Fetal miscarriage | From 10 weeks of gestation to delivery | Defined as pregnancy loss ≥ 10 weeks size with a fetus (≥ 33 mm) on ultrasound |
| Obstetric outcomes | At time of delivery | Obstetric complications including hypertensive disorders of pregnancy, gestational diabetes, postpartum hemorrhage and cesarean section |
| Perinatal outcomes | At time of delivery | Preterm birth, birth weight, congenital malformations, and perinatal mortality (defined as foetal or neonatal death from GA 22+0 to 7 days after birth). |
| Hormone levels | Time of insemination and mid-luteal phase (approximately 7-9 days after insemination). | Serum hormone levels measured on the day of insemination, in the mid-luteal phase and on the day of ovulation trigger (optional), including progesterone, estradiol, LH and FSH. |
Countries
Denmark
Contacts
CONTACTKirstine Kirkegaard, Clinical Associate Professor
PRINCIPAL_INVESTIGATORKirstine Kirkegaard, Clinical Associate Professor
University Clinic for Fertility, Horsens Regional Hospital, Central Denmark Region
Outcome results
None listed