IVFPhase 3PROTECTANCT04806919
Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone
A Phase 3 study testing Progesteron TID in people with IVF and Embryo Loss, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
The study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as < 10 mcg/l) on the day of blastocyst transfer. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- IVF, Embryo Loss, Luteal Phase Defect
- What is being tested?
- Progesteron TID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesBelgium
- Study dates
- 2 Apr 2021to 31 Mar 2025
- Phase
- Phase 3
- 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
- Informed consent form (ICF) dated and signed
- Age ≥ 18 and < 43 years old
- Body Mass Index (BMI) ≥ 18.5 kg/m2 and < 35 kg/m2
- Less than 4 previous Assisted Reproductive Technologies (ART) cycles
- Current pregnancy wish
- Patients undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle (IVF or ICSI)
Who cannot join
- Simultaneous participation in another clinical study
- Previous participation in this study
- Known reasons for impaired implantation (specifically: presence of a hydrosalpinx; presence of a type I, II or III fibroid; Asherman's syndrome; uterine malformations, intrauterine adhesions, ≥ grade 3 endometriosis according to the ASRM classification, endometrial tuberculosis)
- Repeated miscarriages (> 2 miscarriages)
- Untreated and uncontrolled thyroid dysfunction
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus
Show all 16Show fewer
- Abnormal vaginal bleeding without a known/diagnosed cause
- Ovarian cysts or enlarged ovaries
- Fibroid tumors of the uterus incompatible with pregnancy
- Malformations of the reproductive organs incompatible with pregnancy
- Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin)
- Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia
- Active smoking
- Ongoing pregnancy
- Use of carbamazepine, rifampicin or phenytoin
- Those unable to comprehend the investigational nature of the proposed study
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Micronized Progesterone (Amelgen ®) 400 mg BID Versus 400 mg TID for Luteal Support in Artificial Vitrified/Warmed Single Blastocyst Transfer Cycles With Low Progesterone on Day of Embryo Transfer
The study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as < 10 mcg/l) on the day of blastocyst transfer.
- Conditions
- IVF, Embryo Loss, Luteal Phase Defect
- Being tested
- Progesteron TID
- Medical subject headings
- Embryo Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesteron TIDDrug
increasing the dose
| Study group | Role | What they receive |
|---|---|---|
| Control group: Amelgen ® 400 mg BID | No intervention | Continue daily dose progesteron |
| Intervention group: Amelgen ® 400 mg TID | Experimental | Increase daily progesteron dose Receives: Drug: Progesteron TID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
visualization of an embryo with a heart beat
Measured: 7 gestational weeks (+ or - 1 week)
Secondary outcomes (1)
Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate
Measured: 7 gestational weeks (+ or - 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start2 Apr 2021
- Primary completion28 Feb 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806919
- Sponsor's protocol ID
- 2020-004112-10
- Acronym
- PROTECTA
- Status last verified
- Mar 2026
- First submitted
- 18 Jan 2021
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Micronized Progesterone (Amelgen ®) 400 mg BID Versus 400 mg TID for Luteal Support in Artificial Vitrified/Warmed Single Blastocyst Transfer Cycles With Low Progesterone on Day of Embryo Transfer
- ClinicalTrials.gov ID
- NCT04806919
- Acronym / sponsor ID
- PROTECTA / 2020-004112-10
- Conditions
- IVF, Embryo Loss, Luteal Phase Defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 19 Mar 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 study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as < 10 mcg/l) on the day of blastocyst transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: Amelgen ® 400 mg BID | No intervention | –Continue daily dose progesteron |
| Intervention group: Amelgen ® 400 mg TID | Experimental | Drug: Progesteron TIDIncrease daily progesteron dose |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent form (ICF) dated and signed
- Age ≥ 18 and < 43 years old
- Body Mass Index (BMI) ≥ 18.5 kg/m2 and < 35 kg/m2
- Less than 4 previous Assisted Reproductive Technologies (ART) cycles
- Current pregnancy wish
Key exclusion criteria (16 listed)
- Simultaneous participation in another clinical study
- Previous participation in this study
- Known reasons for impaired implantation (specifically: presence of a hydrosalpinx; presence of a type I, II or III fibroid; Asherman's syndrome; uterine malformations, intrauterine adhesions, ≥ grade 3 endometriosis according to the ASRM classification, endometrial tuberculosis)
- Repeated miscarriages (> 2 miscarriages)
- Untreated and uncontrolled thyroid dysfunction
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 |
|---|---|---|
| Progesteron TIDincreasing the dose | Drug | Intervention group: Amelgen ® 400 mg TID |
Primary outcome
Ongoing pregnancy rate
Time frame: 7 gestational weeks (+ or - 1 week)
visualization of an embryo with a heart beat
1 secondary outcome
Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate
Time frame: 7 gestational weeks (+ or - 1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for IVF
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Active, not recruitingPhase 1/2
Opt-IVF for Personalized Medicine for Normal Responders
Ivf
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Progesteron TID in people with IVF and Embryo Loss, run by University Hospital, Ghent at 2 sites in Belgium.
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 6 inclusion and 16 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: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 7 gestational weeks (+ or - 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.