Progesterone as Luteal Support in Frozen IVF Natural Cycles
NCT ID: NCT04725864
Last Updated: 2024-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1800 participants
INTERVENTIONAL
2021-05-01
2025-12-31
Brief Summary
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Detailed Description
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The ProFET study is a multicenter, open randomized, controlled trial planning to include 1800 women, intended to undergo a FET in a natural cycle.
Primary objectives are 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, in a natural cycle and if 7 weeks of treatment is superior to 3 weeks duration.
Secondary objectives are to compare groups regarding pregnancy outcomes including biochemical pregnancy, clinical, ongoing and term pregnancy rates, as well as rates of miscarriage, termination of pregnancy, and ectopic pregnancy.
Secondary objectives are also perinatal and obstetrics outcomes, self-reported side effects, adverse events and cost effectiveness.
The investigators will also analyze the effect of S-Progesterone level before FET on the chance of achieving live birth and secondary pregnancy outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No progesterone
Patients will have FET in natural cycles with no extra intervention.
No interventions assigned to this group
Progesterone for 3 weeks
At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for three weeks.
Progesterone vaginal tablet
The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily.
Progesterone for 7 weeks
At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for seven weeks.
Progesterone vaginal tablet
The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily.
Interventions
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Progesterone vaginal tablet
The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI \>18.5 \<35
* Regular menstrual cycles 24-35 days
* Given informed consent
* Understand written and spoken Swedish, English or Arabic
Exclusion Criteria
* 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.
18 Years
43 Years
FEMALE
No
Sponsors
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Göteborg University
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Åsa Magnusson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vastra Gotaland
Locations
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Department of Reproductive Medicine
Gothenburg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Duffy JMN, AlAhwany H, Bhattacharya S, Collura B, Curtis C, Evers JLH, Farquharson RG, Franik S, Giudice LC, Khalaf Y, Knijnenburg JML, Leeners B, Legro RS, Lensen S, Vazquez-Niebla JC, Mavrelos D, Mol BWJ, Niederberger C, Ng EHY, Otter AS, Puscasiu L, Rautakallio-Hokkanen S, Repping S, Sarris I, Simpson JL, Strandell A, Strawbridge C, Torrance HL, Vail A, van Wely M, Vercoe MA, Vuong NL, Wang AY, Wang R, Wilkinson J, Youssef MA, Farquhar CM; Core Outcome Measure for Infertility Trials (COMMIT) initiative. Developing a core outcome set for future infertility research: an international consensus development studydagger double dagger. Hum Reprod. 2020 Dec 1;35(12):2725-2734. doi: 10.1093/humrep/deaa241.
Stadelmann C, Bergh C, Brannstrom M, Olsen KH, Khatibi A, Kitlinski M, Liffner S, Lundborg E, Rodriguez-Wallberg KA, Strandell A, Westlander G, Widlund G, Magnusson A. Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial. BMJ Open. 2022 Jul 8;12(7):e062400. doi: 10.1136/bmjopen-2022-062400.
Related Links
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EUROCAT classification system
Other Identifiers
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2020-005552-38
Identifier Type: -
Identifier Source: org_study_id
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