Authorised Therapeutic use (Phase IV) Infertility

Vaginal progesterone as luteal support for improvement of live birth in frozen/thawed in-vitro fertilization natural cycles; a multicenter, open, randomized trial.

EU CTIS ID: 2024-512844-40-00

What this study is testing

The primary objective is to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth per woman undergoing FET-NC, and if superiority is shown, if 7 weeks of progesterone treatment is superior to 3 weeks treatment.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Planned for a FET-NC with a blastocyst
  • Age≥18<43 years
  • BMI≥18.5<35
  • Regular menstrual cycles 24-35 days
  • Given informed consent
  • Understand written and spoken Swedish, English or Arabic

You likely can't join if

  • ART-related: Oocyte donor cycles. Preimplantation Genetic Testing (PGT) cycles. Uterine malformation, precluding cervical access to the uterine cavity. Submucous myoma and endometrial polyps requiring surgery before transfer of embryo.
  • Drug-related: Hypersensitivity against study medication. Other contraindications according to FASS: Undiagnosed vaginal bleeding, severely impaired liver function or liver disease, known or suspected malignancy of breast or genital region, ongoing arterial or venous thromboembolism, porphyria or history of these conditions (FASS.se).
  • Development of serious disease contraindicating ART or pregnancy.
  • Participation or recent participation in a clinical study with an investigational product (during the past 30 days). Previous participation in this study.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.