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

April 23, 2024 updated by: Vastra Gotaland Region

Vaginal Progesterone as Luteal Support for Improvement of Live Birth in Frozen/Thawed In-vitro Fertilization Natural Cycles; a Multicenter, Open, Randomized Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No progesterone
Patients will have FET in natural cycles with no extra intervention.
Experimental: Progesterone for 3 weeks
At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for three weeks.
Drug: Progesterone vaginal tablet
The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily.
Other Names:
  • Lutinus, manufactured by Ferring GmbH. ATC code G03DA04
Experimental: Progesterone for 7 weeks
At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for seven weeks.
Drug: Progesterone vaginal tablet
The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily.
Other Names:
  • Lutinus, manufactured by Ferring GmbH. ATC code G03DA04

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with live birth
Time Frame: Up to 41 weeks after embryo transfer.
A child born alive. Also, the outcome will be reported according to Core Outcome Measure for Infertility Trials (Duffy et al., 2020) in a separate appendix.
Up to 41 weeks after embryo transfer.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with biochemical pregnancy
Time Frame: 2-3 weeks after embryo transfer.
A pregnancy diagnosed only by the detection of beta hCG in serum or urine.
2-3 weeks after embryo transfer.
Number of participants with clinical pregnancy
Time Frame: 4-8 weeks after embryo transfer.
A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs.
4-8 weeks after embryo transfer.
Number of participants with ongoing pregnancy
Time Frame: 5-7 weeks after embryo transfer.
An intrauterine pregnancy with one or more fetuses with heartbeats measured in gestational week 7+5 to 9+0 with vaginal ultrasound.
5-7 weeks after embryo transfer.
Number of participants with miscarriage
Time Frame: Up to 20 weeks after embryo transfer.
The spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age. Also, the outcome will be reported according to Core Outcome Measure for Infertility Trials (Duffy et al., 2020) in a separate appendix.
Up to 20 weeks after embryo transfer.
Number of participants with ectopic pregnancy
Time Frame: Up to 20 weeks after embryo transfer.
A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology.
Up to 20 weeks after embryo transfer.
Number of participants with termination of pregnancy
Time Frame: Up to 20 weeks after embryo transfer.
Defined as the termination of a clinical pregnancy, by deliberate interference that takes place before 22 completed weeks of gestational age. Also, the outcome will be reported according to Core Outcome Measure for Infertility Trials (Duffy et al., 2020) in a separate appendix.
Up to 20 weeks after embryo transfer.
Birth weight
Time Frame: Up to 41 weeks after embryo transfer.
Defined as weight in grams at birth.
Up to 41 weeks after embryo transfer.
Gestational age at delivery
Time Frame: Up to 41 weeks after embryo transfer.
The gestational age at FET is calculated by adding the number of culture days to ovulation (ovulation=day 14). Gestational age at delivery is then calculated by adding the number of days since FET.
Up to 41 weeks after embryo transfer.
Preterm birth
Time Frame: Up to 35 weeks after embryo transfer.
Defined as a child born alive before 37 completed weeks of pregnancy.
Up to 35 weeks after embryo transfer.
Very preterm birth
Time Frame: Up to 30 weeks after embryo transfer.
Defined as a child born alive before 32 completed weeks of pregnancy.
Up to 30 weeks after embryo transfer.
Low birth weight
Time Frame: Up to 41 weeks after embryo transfer.
Birth weight less than 2500 g.
Up to 41 weeks after embryo transfer.
Very low birth weight
Time Frame: Up to 41 weeks after embryo transfer.
Birth weight less than 1500 g.
Up to 41 weeks after embryo transfer.
Stillbirth
Time Frame: Up to 41 weeks after embryo transfer.
The death of a fetus prior to the complete expulsion or extraction from its mother, after and including 22 completed weeks of gestational age. Also, the outcome will be reported according to Core Outcome Measure for Infertility Trials (Duffy et al., 2020) in a separate appendix.
Up to 41 weeks after embryo transfer.
Perinatal death
Time Frame: Up to 41 weeks after embryo transfer and 7 days after birth.
Fetal or neonatal death occurring during late pregnancy (at 22 completed weeks of gestational age and later), during childbirth, or up to seven days after birth. Also, the outcome will be reported according to Core Outcome Measure for Infertility Trials (Duffy et al., 2020) in a separate appendix.
Up to 41 weeks after embryo transfer and 7 days after birth.
Number of children with birth defects
Time Frame: Up to 41 weeks after embryo transfer.
Congenital birth defects were defined according the International Statistical Classification of Diseases and Related Health Problems (ICD-10). And further defined according to the EUROCAT classification system.
Up to 41 weeks after embryo transfer.
Number of children admitted to Neonatal Intensive Care Unit (NICU)
Time Frame: Up to 41 weeks after embryo transfer and 7 days after birth.
Defined as children that were admitted to NICU after birth.
Up to 41 weeks after embryo transfer and 7 days after birth.
Number of participants with hypertensive disorders of pregnancy
Time Frame: Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.
Hypertensive disorders of pregnancy defined as high blood pressure disorders including preeclampsia, gestational hypertension and chronic hypertension.
Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.
Number of participants with placenta previa
Time Frame: Up to 41 weeks after embryo transfer.
Defined as a placenta covering the internal os of the cervix, at time of delivery.
Up to 41 weeks after embryo transfer.
Number of participants with placenta abruption
Time Frame: Up to 41 weeks after embryo transfer.
Defined as the premature separation of a normally located placenta from the uterine wall that occurs before delivery of the fetus.
Up to 41 weeks after embryo transfer.
Number of participants with postpartum hemorrhage
Time Frame: Up to 41 weeks after embryo transfer.
Defined as a cumulative blood loss of greater than 1,000 mL or blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after the birth process.
Up to 41 weeks after embryo transfer.
Number of participants with Cesarean section
Time Frame: Up to 41 weeks after embryo transfer.
Defined as a surgical procedure used to deliver a baby through incisions in the abdomen and uterus.
Up to 41 weeks after embryo transfer.
Number of participants with thromboembolic events
Time Frame: Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.
Defined as formation in a blood vessel of a clot (thrombus) that breaks loose and is carried by the blood stream to plug another vessel.
Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.
Maternal mortality
Time Frame: Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.
Defined as female deaths from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth.
Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.
Number of participants with treatment related side effects
Time Frame: Up to 8 weeks after embryo transfer.
Side effects reported according to study specific questionnaire. Questions are answered with yes or no. If yes, symptoms are described, but not by using a scale.
Up to 8 weeks after embryo transfer.
Number of participants with adverse events
Time Frame: Up to 8 weeks after embryo transfer.
Any untoward medical occurrence in symptom or disease temporally associated with the use of the medicinal (investigational) product, whether or not related to the medicinal product.
Up to 8 weeks after embryo transfer.
Cost effectiveness
Time Frame: After study completion, an average of 1 year.
Comparison between groups regarding the total costs for the intervention divided by treatment efficacy (live birth).
After study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Göteborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Åsa Magnusson, MD, PhD, Vastra Gotaland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-005552-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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