Fertility IssuesPhase 2P4RNCT05555121
Rescue Progesterone Supplementation During Frozen Embryo Transfer
A Phase 2 study testing Progesterone Effervescent Vaginal Tablet in people with Fertility Issues and Embryo Implantation, run by Clinique Ovo at 1 site in Canada.
Trial summary
Endometrin is a progesterone supplement prescribed during in vitro fertilization (IVF) for preparation for embryo transfer. The usual dose of Endometrin is 100 mg two to three times per day in the form of an effervescent tablet to be inserted vaginally. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Fertility Issues, Embryo Implantation, Frozen Embryo Transfer
- What is being tested?
- Progesterone Effervescent Vaginal Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2022to 30 Jun 2028
- Phase
- Phase 2
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18-42 years of age
- Normal uterine cavity (according to treating physician)
- FET substituted cycle prescribed
- First or second cycle of FET
- Adequate endometrial pattern (triple layer) and thickness (>7 mm) after adequate standard endometrial preparation in artificial cycle
Who cannot join
- Any uterine abnormalities confirmed by treating physician making participant unable to proceed with FET
- Patients with personalized FET according to the endometrial receptivity assay tests
- Previous allergic reactions to progesterone or any of the ingredients of Endometrin
- Severe hepatic dysfunction or disease
- Known or suspected breast cancer or genital tract cancer
- Known active arterial or venous thromboembolism or severe thrombophlebitis or cerebro-vascular disease, or a history of these events
Show all 16Show fewer
- Diagnosed porphyria
- Undiagnosed abnormal vaginal bleeding
- Known missed abortion or ectopic pregnancy
- Recurrent pregnancy loss excluding biochemical pregnancies
- Hypersensitivity to Acetylsalicylic acid (ASA), salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, antipyretics or other ingredients in the product or component of the container
- Acute gastrointestinal ulcer, history of gastrointestinal ulcers and hemorrhagic diathesis
- Active or severe renal disease, or congestive heart failure
- History of asthma induced by salicylates or other NSAIDs
- Use of methotrexate at doses of 15mg/week or more
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rescue Progesterone Supplementation in Patients With Low Progesterone on the Day of Embryo Transfer for Artificial Endometrial Preparation Cycles: a Non-inferiority Study
Endometrin is a progesterone supplement prescribed during in vitro fertilization (IVF) for preparation for embryo transfer. The usual dose of Endometrin is 100 mg two to three times per day in the form of an effervescent tablet to be inserted vaginally.
The purpose of this research project is to evaluate the dose response of the Endometrin when determined based on the blood level of progesterone on the day of the FET. According to the literature, a predefined level of progesterone in the blood should be reached in order to have favorable conditions for pregnancy. The hypothesis being that a woman with low progesterone levels would benefit from a dose of Endometrin of 600 mg (200 mg 3x/day) to decrease the risk of miscarriage and improve the chances of pregnancy. Women with adequate progesterone levels according to the literature, would continue with the standard dose of progesterone prescribed at clinique ovo which is 300 mg (100 mg 3x/day).
PIBF (Progesterone Induced Blocking Factor) levels, a protein found in the blood that could also predict pregnancy outcomes in women using IVF will also be looked at.
- Being tested
- Progesterone Effervescent Vaginal Tablet
- Keywords
- Embryo, Frozen embryo transfer, Progesterone, Embryo implantation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone Effervescent Vaginal TabletDrug
Also called Endometrin
On the day of Frozen Embryo Transfer (FET), women will have a blood test to determine progesterone levels. Depending on the result of progesterone level, the participant will be assigned to either the Endometrin 100 mg TID dose or the Endometrin 200 mg TID dose
| Study group | Role | What they receive |
|---|---|---|
| Endometrin 100 mg three times per day (TID) | Active comparator | Women with progesterone levels ≥ 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 100 mg TID until 10th week of pregnancy Receives: Drug: Progesterone Effervescent Vaginal Tablet |
| Endometrin 200 mg three times per day (TID) | Active comparator | Women with progesterone levels < 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 200 mg TID until 10th week of pregnancy Receives: Drug: Progesterone Effervescent Vaginal Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the ongoing pregnancy rate
Viability ultrasound
Measured: 6 to 8 weeks after Frozen Embryo Transfer
Secondary outcomes (3)
Evaluate the miscarriage rate
Viability ultrasound
Measured: 6 to 8 weeks after Frozen Embryo Transfer
Evaluate progesterone levels
Progesterone levels will be tested at two different times
Measured: Before embryo transfer and 10 days after embryo transfer
Evaluate the rate of biochemical pregnancy
Serum pregnancy test to measure Beta Human Chorionic Gonadotropin (BhCG) levels
Measured: 10 days after frozen embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Dec 2022
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Why it stopped: Study medication temporarly not available in Canada.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single centre, prospective, open label study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Wael Jamal, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555121
- Sponsor's protocol ID
- IIS-1032
- Acronym
- P4R
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue Progesterone Supplementation in Patients With Low Progesterone on the Day of Embryo Transfer for Artificial Endometrial Preparation Cycles: a Non-inferiority Study
- ClinicalTrials.gov ID
- NCT05555121
- Acronym / sponsor ID
- P4R / IIS-1032
- Keywords
- Embryo, Frozen embryo transfer, Progesterone, Embryo implantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study medication temporarly not available in Canada.
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Sep 2022 (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.
Endometrin is a progesterone supplement prescribed during in vitro fertilization (IVF) for preparation for embryo transfer. The usual dose of Endometrin is 100 mg two to three times per day in the form of an effervescent tablet to be inserted vaginally.
The purpose of this research project is to evaluate the dose response of the Endometrin when determined based on the blood level of progesterone on the day of the FET. According to the literature, a predefined level of progesterone in the blood should be reached in order to have favorable conditions for pregnancy. The hypothesis being that a woman with low progesterone levels would benefit from a dose of Endometrin of 600 mg (200 mg 3x/day) to decrease the risk of miscarriage and improve the chances of pregnancy. Women with adequate progesterone levels according to the literature, would continue with the standard dose of progesterone prescribed at clinique ovo which is 300 mg (100 mg 3x/day).
PIBF (Progesterone Induced Blocking Factor) levels, a protein found in the blood that could also predict pregnancy outcomes in women using IVF will also be looked at.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single centre, prospective, open label study
| Arm | Type | Receives |
|---|---|---|
| Endometrin 100 mg three times per day (TID) | Active comparator | Drug: Progesterone Effervescent Vaginal TabletWomen with progesterone levels ≥ 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 100 mg TID until 10th week of pregnancy |
| Endometrin 200 mg three times per day (TID) | Active comparator | Drug: Progesterone Effervescent Vaginal TabletWomen with progesterone levels < 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 200 mg TID until 10th week of pregnancy |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women 18-42 years of age
- Normal uterine cavity (according to treating physician)
- FET substituted cycle prescribed
- First or second cycle of FET
- Adequate endometrial pattern (triple layer) and thickness (>7 mm) after adequate standard endometrial preparation in artificial cycle
Key exclusion criteria (16 listed)
- Any uterine abnormalities confirmed by treating physician making participant unable to proceed with FET
- Patients with personalized FET according to the endometrial receptivity assay tests
- Previous allergic reactions to progesterone or any of the ingredients of Endometrin
- Severe hepatic dysfunction or disease
- Known or suspected breast cancer or genital tract cancer
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 Effervescent Vaginal TabletAlso: EndometrinOn the day of Frozen Embryo Transfer (FET), women will have a blood test to determine progesterone levels. Depending on the result of progesterone level, the participant will be assigned to either the Endometrin 100 mg TID dose or the Endometrin 200 mg TID dose | Drug | Endometrin 100 mg three times per day (TID), Endometrin 200 mg three times per day (TID) |
Primary outcome
Evaluate the ongoing pregnancy rate
Time frame: 6 to 8 weeks after Frozen Embryo Transfer
Viability ultrasound
3 secondary outcomes
Evaluate the miscarriage rate
Time frame: 6 to 8 weeks after Frozen Embryo Transfer
Evaluate progesterone levels
Time frame: Before embryo transfer and 10 days after embryo transfer
Evaluate the rate of biochemical pregnancy
Time frame: 10 days after frozen embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- 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.
Wael Jamal, MD principal investigator
Clinique Ovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Progesterone Effervescent Vaginal Tablet in people with Fertility Issues and Embryo Implantation, run by Clinique Ovo at 1 site in Canada.
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 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: paused, as of the sponsor's last update on 9 Dec 2025. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Evaluate the ongoing pregnancy rate (time frame: 6 to 8 weeks after Frozen Embryo Transfer). 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 9 Dec 2025.