InfertilityPhase 4ProFETNCT04725864
Progesterone as Luteal Support in Frozen IVF Natural Cycles
A Phase 4 study testing Progesterone vaginal tablet in people with Infertility and Embryo Transfer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility, Embryo Transfer
- What is being tested?
- Progesterone vaginal tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2021to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Reproductive Medicine
Gothenburg, S-41345
Åsa Magnusson, MD,PhD, +46313421000 ext. 29560, asa.magnusson@vgregion.se
Caroline Stadelmann, MD, +46739031413, caroline.stadelmann@vgregion.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility, Embryo Transfer
- Being tested
- Progesterone vaginal tablet
- Keywords
- progesterone, luteal phase support, frozen embryo transfer, natural cycles, live birth
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone vaginal tabletDrug
Also called Lutinus, manufactured by Ferring GmbH. ATC code G03DA04
The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily.
| Study group | Role | What they receive |
|---|---|---|
| No progesterone | No intervention | Patients will have FET in natural cycles with no extra intervention. |
| Progesterone for 3 weeks | Experimental | At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for three weeks. Receives: Drug: Progesterone vaginal tablet |
| Progesterone for 7 weeks | Experimental | At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for seven weeks. Receives: Drug: Progesterone vaginal tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with live birth
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.
Measured: Up to 41 weeks after embryo transfer.
Secondary outcomes (26)
Number of participants with biochemical pregnancy
A pregnancy diagnosed only by the detection of beta hCG in serum or urine.
Measured: 2-3 weeks after embryo transfer.
Number of participants with clinical pregnancy
A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs.
Measured: 4-8 weeks after embryo transfer.
Number of participants with ongoing pregnancy
An intrauterine pregnancy with one or more fetuses with heartbeats measured in gestational week 7+5 to 9+0 with vaginal ultrasound.
Measured: 5-7 weeks after embryo transfer.
Number of participants with miscarriage
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.
Measured: Up to 20 weeks after embryo transfer.
Number of participants with ectopic pregnancy
A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology.
Measured: Up to 20 weeks after embryo transfer.
Number of participants with termination of pregnancy
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.
Measured: Up to 20 weeks after embryo transfer.
Birth weight
Defined as weight in grams at birth.
Measured: Up to 41 weeks after embryo transfer.
Gestational age at delivery
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.
Measured: Up to 41 weeks after embryo transfer.
Preterm birth
Defined as a child born alive before 37 completed weeks of pregnancy.
Measured: Up to 35 weeks after embryo transfer.
Very preterm birth
Defined as a child born alive before 32 completed weeks of pregnancy.
Measured: Up to 30 weeks after embryo transfer.
Low birth weight
Birth weight less than 2500 g.
Measured: Up to 41 weeks after embryo transfer.
Very low birth weight
Birth weight less than 1500 g.
Measured: Up to 41 weeks after embryo transfer.
Stillbirth
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.
Measured: Up to 41 weeks after embryo transfer.
Perinatal death
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.
Measured: Up to 41 weeks after embryo transfer and 7 days after birth.
Number of children with birth defects
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.
Measured: Up to 41 weeks after embryo transfer.
Number of children admitted to Neonatal Intensive Care Unit (NICU)
Defined as children that were admitted to NICU after birth.
Measured: Up to 41 weeks after embryo transfer and 7 days after birth.
Number of participants with hypertensive disorders of pregnancy
Hypertensive disorders of pregnancy defined as high blood pressure disorders including preeclampsia, gestational hypertension and chronic hypertension.
Measured: Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.
Number of participants with placenta previa
Defined as a placenta covering the internal os of the cervix, at time of delivery.
Measured: Up to 41 weeks after embryo transfer.
Number of participants with placenta abruption
Defined as the premature separation of a normally located placenta from the uterine wall that occurs before delivery of the fetus.
Measured: Up to 41 weeks after embryo transfer.
Number of participants with postpartum hemorrhage
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.
Measured: Up to 41 weeks after embryo transfer.
Number of participants with Cesarean section
Defined as a surgical procedure used to deliver a baby through incisions in the abdomen and uterus.
Measured: Up to 41 weeks after embryo transfer.
Number of participants with thromboembolic events
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.
Measured: Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.
Maternal mortality
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.
Measured: Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.
Number of participants with treatment related side effects
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.
Measured: Up to 8 weeks after embryo transfer.
Number of participants with adverse events
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.
Measured: Up to 8 weeks after embryo transfer.
Cost effectiveness
Comparison between groups regarding the total costs for the intervention divided by treatment efficacy (live birth).
Measured: After study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 May 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two main arms, of which the experimental arm is split in two arms with different duration of treatment
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Åsa Magnusson, MD, PhD, Principal investigator, Vastra Gotaland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725864
- Sponsor's protocol ID
- 2020-005552-38
- Acronym
- ProFET
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2021
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33252685Stadelmann 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.
PubMed 35803628
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Progesterone as Luteal Support for Improvement of Live Birth in Frozen/Thawed In-vitro Fertilization Natural Cycles; a Multicenter, Open, Randomized Trial
- ClinicalTrials.gov ID
- NCT04725864
- Acronym / sponsor ID
- ProFET / 2020-005552-38
- Conditions
- Infertility, Embryo Transfer
- Keywords
- progesterone, luteal phase support, frozen embryo transfer, natural cycles, live birth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Two main arms, of which the experimental arm is split in two arms with different duration of treatment
| Arm | Type | Receives |
|---|---|---|
| No progesterone | No intervention | –Patients will have FET in natural cycles with no extra intervention. |
| Progesterone for 3 weeks | Experimental | Drug: Progesterone vaginal tabletAt day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for three weeks. |
| Progesterone for 7 weeks | Experimental | Drug: Progesterone vaginal tabletAt day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for seven weeks. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone vaginal tabletAlso: Lutinus, manufactured by Ferring GmbH. ATC code G03DA04The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily. | Drug | Progesterone for 3 weeks, Progesterone for 7 weeks |
Primary outcome
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.
26 secondary outcomes
Number of participants with biochemical pregnancy
Time frame: 2-3 weeks after embryo transfer.
Number of participants with clinical pregnancy
Time frame: 4-8 weeks after embryo transfer.
Number of participants with ongoing pregnancy
Time frame: 5-7 weeks after embryo transfer.
Number of participants with miscarriage
Time frame: Up to 20 weeks after embryo transfer.
Number of participants with ectopic pregnancy
Time frame: Up to 20 weeks after embryo transfer.
Number of participants with termination of pregnancy
Time frame: Up to 20 weeks after embryo transfer.
Birth weight
Time frame: Up to 41 weeks after embryo transfer.
Gestational age at delivery
Time frame: Up to 41 weeks after embryo transfer.
Preterm birth
Time frame: Up to 35 weeks after embryo transfer.
Very preterm birth
Time frame: Up to 30 weeks after embryo transfer.
Low birth weight
Time frame: Up to 41 weeks after embryo transfer.
Very low birth weight
Time frame: Up to 41 weeks after embryo transfer.
Stillbirth
Time frame: Up to 41 weeks after embryo transfer.
Perinatal death
Time frame: 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.
Number of children admitted to Neonatal Intensive Care Unit (NICU)
Time frame: 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.
Number of participants with placenta previa
Time frame: Up to 41 weeks after embryo transfer.
Number of participants with placenta abruption
Time frame: Up to 41 weeks after embryo transfer.
Number of participants with postpartum hemorrhage
Time frame: Up to 41 weeks after embryo transfer.
Number of participants with Cesarean section
Time frame: 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.
Maternal mortality
Time frame: 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.
Number of participants with adverse events
Time frame: Up to 8 weeks after embryo transfer.
Cost effectiveness
Time frame: After study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Results publication: PubMed 33252685Duffy 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.
- Derived from this study: PubMed 35803628Stadelmann 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.
- EUROCAT classification systemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Åsa Magnusson, MD, PhD principal investigator
Vastra Gotaland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progesterone vaginal tablet in people with Infertility and Embryo Transfer, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Åsa Magnusson, MD, PhD (+46 70-265 55 85, asa.magnusson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with live birth (time frame: Up to 41 weeks after embryo transfer.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04725864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.