Progesterone as Luteal Support in Frozen IVF Natural Cycles
Launched by VASTRA GOTALAND REGION · Jan 21, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The ProFET study is a clinical trial that looks at how vaginal progesterone, a hormone, can help support women during the luteal phase of their menstrual cycle after having a frozen embryo transfer (FET) following in-vitro fertilization (IVF). The researchers want to find out if using progesterone can lead to a higher chance of having a live birth compared to not using it at all, and whether treating for 7 weeks is more effective than treating for just 3 weeks.
To participate in this study, women must be planning for a frozen embryo transfer with a specific type of embryo called a blastocyst, have a body mass index (BMI) between 18.5 and 35, and have regular menstrual cycles. Participants need to understand either Swedish, English, or Arabic, and they must provide informed consent. The study is currently recruiting participants, and those who join can expect to receive either the progesterone treatment or no treatment at all while being closely monitored throughout the process. It's important to note that certain medical conditions or previous participation in other studies may exclude some women from joining this trial.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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.
About Vastra Gotaland Region
Vastra Gotaland Region is a prominent healthcare organization in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. As a sponsor, the region leverages its extensive network of hospitals and healthcare professionals to facilitate high-quality research initiatives that address pressing health challenges. With a commitment to ethical standards and patient safety, Vastra Gotaland Region strives to foster collaboration between researchers, clinicians, and patients, ensuring that clinical trials contribute valuable insights and advancements in medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Gothenburg, , Sweden
Patients applied
Trial Officials
Åsa Magnusson, MD, PhD
Principal Investigator
Vastra Gotaland
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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