Progesterone as Luteal Support in Frozen IVF Natural Cycles
Vaginal Progesterone as Luteal Support for Improvement of Live Birth in Frozen/Thawed In-vitro Fertilization Natural Cycles; a Multicenter, Open, Randomized Trial
Vastra Gotaland Region
1,800 participants
May 1, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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
Exclusion Criteria4
- Oocyte donor cycles, preimplantation genetic testing (PGT) cycles. Uterine malformation, submucous myoma and endometrial polyps.
- Hypersensitivity against study medication. Other contraindications according to www.fass.se
- Development of serious disease contraindicating ART or pregnancy.
- Participation or recent participation in a clinical study with an investigational product (past 30 days). Previous participation in this study.
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Interventions
The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04725864