Vaginal Progesterone as Luteal Support for Improvement of Live Birth in Frozen/Thawed In-vitro Fertilization Natural Cycles; a Multicenter, Open, Randomized Trial
Who is this study for? Patients with Infertility
What treatments are being studied? Progesterone Vaginal Tablet
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The ProFET study aims to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth rate per woman after a frozen embryo transfer (FET), in a natural cycle (NC) after in-vitro fertilization (IVF), and if 7 weeks of treatment is superior to 3 weeks duration.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 43
Healthy Volunteers: f
View:
• Planned for a FET-NC with a blastocyst
• BMI \>18.5 \<35
• Regular menstrual cycles 24-35 days
• Given informed consent
• Understand written and spoken Swedish, English or Arabic
Locations
Other Locations
Sweden
Department of Reproductive Medicine
RECRUITING
Gothenburg
Contact Information
Primary
Åsa Magnusson, MD, PhD
asa.magnusson@vgregion.se
+46 70-265 55 85
Backup
Caroline Stadelmann, MD
caroline.stadelmann@vgregion.se
+46 73-903 14 13
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1800
Treatments
No_intervention: No progesterone
Patients will have FET in natural cycles with no extra intervention.
Experimental: Progesterone for 3 weeks
At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for three weeks.
Experimental: Progesterone for 7 weeks
At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for seven weeks.
Related Therapeutic Areas
Sponsors
Leads: Vastra Gotaland Region
Collaborators: Göteborg University