Progesterone as Luteal Support in Frozen IVF Natural Cycles (ProFET)

Vastra Gotaland Region

Status and phase: Enrolling; Phase 4

Conditions: Infertility; Embryo Transfer

Treatments: Drug: Progesterone vaginal tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04725864

2020-005552-38

Details and patient eligibility

About

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.

Full description

Vaginal progesterone supplementation is routine treatment after IVF with fresh embryo transfer, but it is uncertain whether vaginal progesterone after frozen embryo transfer in natural cycles is efficacious in terms of increasing the chance of a live birth.

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.

Enrollment: 1,800 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,800 participants in 3 patient groups

No progesterone

No Intervention group

Description:

Patients will have FET in natural cycles with no extra intervention.

Progesterone for 3 weeks

Experimental group

Description:

At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for three weeks.

Treatment:

Drug: Progesterone vaginal tablet

Progesterone for 7 weeks

Experimental group

Description:

At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for seven weeks.

Treatment:

Drug: Progesterone vaginal tablet