Progesterone Supplementation After Letrozole-stimulated Insemination

Phase 4Not Yet RecruitingNCT07508657

Kirstine Kirkegaard690 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

690

Conditions

Infertility

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 37 Years

Medical Language ↔ Plain English

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

Locations (4)

Copenhagen University Hospital - Rigshospitalet. Department of Gynecology, Fertility and Obstetrics

Copenhagen, Denmark

The Fertility Clinic, Herlev Hospital

Herlev, Denmark

University Clinic for Fertility, Horsens Regional Hospital, Central Denmark Region

Horsens, Denmark

The Fertility Clinic, Hvidovre Hospital

Hvidovre, Denmark

Outcomes

Primary Outcomes

Clinical Pregnancy Rate

Defined as an ultrasonographically visible foetal heartbeat at 7-9 weeks of gestation

Time frame: Gestational age 7-9 weeks

Secondary Outcomes

Live Birth Rate

Defined as the birth of one or more living infants after a pregnancy of GA ≥ 22 weeks

Time frame: At the time of delivery

Biochemical Pregnancy Rate

Defined as a positive serum or urine β-hCG test 14-17 days after intrauterine insemination

Time frame: 14-17 days after intrauterine insemination

Early Pregnancy Loss

Defined as intrauterine pregnancy loss before 10 weeks of gestational age

Time frame: Up to 10 weeks of gestation

Fetal miscarriage

Defined as pregnancy loss ≥ 10 weeks size with a fetus (≥ 33 mm) on ultrasound

Time frame: From 10 weeks of gestation to delivery

Obstetric outcomes

Obstetric complications including hypertensive disorders of pregnancy, gestational diabetes, postpartum hemorrhage and cesarean section

Time frame: At time of delivery

Perinatal outcomes

Preterm birth, birth weight, congenital malformations, and perinatal mortality (defined as foetal or neonatal death from GA 22+0 to 7 days after birth).