RecruitingPhase 4NCT04725864

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


Sponsor

Vastra Gotaland Region

Enrollment

1,800 participants

Start Date

May 1, 2021

Study Type

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

Sex: FEMALEMin Age: 18 YearsMax Age: 43 Years

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

DRUGProgesterone vaginal tablet

The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily.


Locations(1)

Department of Reproductive Medicine

Gothenburg, Sweden

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NCT04725864


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