NCT Number: NCT07508657
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.
Trial opening soon.
Get Notified18 year–37 year
Female
Interventional
Phase 4
Copenhagen University Hospital - Rigshospitalet. Department of Gynecology, Fertility and Obstetrics, Copenhagen, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Cyclogest
Time frame: Gestational age 7-9 weeks
Defined as an ultrasonographically visible foetal heartbeat at 7-9 weeks of gestation
Time frame: At the time of delivery
Defined as the birth of one or more living infants after a pregnancy of GA ≥ 22 weeks
Time frame: 14-17 days after intrauterine insemination
Defined as a positive serum or urine β-hCG test 14-17 days after intrauterine insemination
Time frame: Up to 10 weeks of gestation
Defined as intrauterine pregnancy loss before 10 weeks of gestational age
Time frame: From 10 weeks of gestation to delivery
Defined as pregnancy loss ≥ 10 weeks size with a fetus (≥ 33 mm) on ultrasound
Time frame: At time of delivery
Obstetric complications including hypertensive disorders of pregnancy, gestational diabetes, postpartum hemorrhage and cesarean section
Time frame: 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).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Kirstine Kirkegaard
Other
Luteal Phase Support Following Letrozole Treatment in Women Undergoing Intrauterine Insemination: a Multicenter Randomized Trial
Acronym: LIFT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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