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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524327-53-00 | EU Trial (CTIS) Number |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Vaginal progesterone luteal phase support. Progesterone is administered as Cyclogest 400 mg twice daily form the day after insemination. Treatment is continued until gestational age 10 weeks in the event of clinical pregnancy, or until pregnancy is ruled out in women who do not achieve a clinical pregnancy. |
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| Comparison | No Intervention | No luteal phase support will be administered after insemination, reflecting current standard treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate | Defined as an ultrasonographically visible foetal heartbeat at 7-9 weeks of gestation | Gestational age 7-9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Live Birth Rate | Defined as the birth of one or more living infants after a pregnancy of GA ≥ 22 weeks | At the time of delivery |
| Biochemical Pregnancy Rate | Defined as a positive serum or urine β-hCG test 14-17 days after intrauterine insemination |
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Inclusion Criteria:
Exclusion Criteria:
Participation is restricted to women of reproductive age with preserved ovarian and uterine function. Inclusion of men is therefore not applicable.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirstine Kirkegaard, Clinical Associate Professor | Contact | +4578426562 | fertilitet@horsens.rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kirstine Kirkegaard, Clinical Associate Professor | University Clinic for Fertility, Horsens Regional Hospital, Central Denmark Region | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital - Rigshospitalet. Department of Gynecology, Fertility and Obstetrics | Copenhagen | 2100 | Denmark |
Individual participant data will not be made avaliable.
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Outcome assessment is performed by a physician masked to treatment allocation. Participants and treating clinical staff are not masked.
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| 14-17 days after intrauterine insemination |
| Early Pregnancy Loss | Defined as intrauterine pregnancy loss before 10 weeks of gestational age | Up to 10 weeks of gestation |
| Fetal miscarriage | Defined as pregnancy loss ≥ 10 weeks size with a fetus (≥ 33 mm) on ultrasound | From 10 weeks of gestation to delivery |
| Obstetric outcomes | Obstetric complications including hypertensive disorders of pregnancy, gestational diabetes, postpartum hemorrhage and cesarean section | 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). | At time of delivery |
| Hormone levels | 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. | Time of insemination and mid-luteal phase (approximately 7-9 days after insemination). |
| The Fertility Clinic, Herlev Hospital | Herlev | 2730 | Denmark |
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| University Clinic for Fertility, Horsens Regional Hospital, Central Denmark Region | Horsens | 8700 | Denmark |
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| The Fertility Clinic, Hvidovre Hospital | Hvidovre | 2650 | Denmark |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |