Health TrialsbyHealthPanel

Progesterone Supplementation After Letrozole-stimulated Insemination

ConditionInfertility
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-37
SponsorKirstine Kirkegaard

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-37 years

Scheduled for IUI with homologous or donor sperm

Undergoing mild ovarian stimulation with letrozole

Ability to provide written informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

690 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ComparisonNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

Early Pregnancy Loss

Defined as intrauterine pregnancy loss before 10 weeks of gestational age

Time frame
Up to 10 weeks of gestation
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kirstine Kirkegaard

Lead sponsor

University of Aarhus

Sponsor institution

Source ClinicalTrials.gov
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