Rescue Progesterone Supplementation During Frozen Embryo Transfer (NCT05555121) | Clinical Trial Compass
SuspendedPhase 2
Rescue Progesterone Supplementation During Frozen Embryo Transfer
Stopped: Study medication temporarly not available in Canada.
Canada150 participantsStarted 2022-12-01
Plain-language 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.
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.
Who can participate
Age range
18 Years – 42 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the ongoing pregnancy rate
Timeframe: 6 to 8 weeks after Frozen Embryo Transfer