Clinical trial NCT05555121: Rescue Progesterone Supplementation During Frozen Embryo Transfer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Fertility Issues
Embryo Implantation
Frozen Embryo Transfer
Keywords: Embryo
Frozen embryo transfer
Progesterone
Embryo implantation
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
Collaborators: name: Ferring Pharmaceuticals
First posted: 2022-09-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single centre, prospective, open label study
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 dehydrogenase (G6PD) deficiency

Primary outcomes:
measure: Evaluate the ongoing pregnancy rate
timeFrame: 6 to 8 weeks after Frozen Embryo Transfer
Secondary outcomes:
measure: Evaluate the miscarriage rate
timeFrame: 6 to 8 weeks after Frozen Embryo Transfer
measure: Evaluate progesterone levels
timeFrame: Before embryo transfer and 10 days after embryo transfer
measure: Evaluate the rate of biochemical pregnancy
timeFrame: 10 days after frozen embryo transfer
Other outcomes:
measure: Blood test to evaluate the prevalence of PIBF
timeFrame: Before embryo transfer and 10 days after embryo transfer
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Wael Jamal, MD
role: PRINCIPAL_INVESTIGATOR
References: