Clincosm LogoSign in Get a demo

P4R: Rescue Progesterone Supplementation During Frozen Embryo Transfer

Sponsor
Clinique Ovo (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05555121
Collaborator
Ferring Pharmaceuticals (Industry)
150
Enrollment
1
Location
2
Arms
19
Anticipated Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Progesterone Effervescent Vaginal Tablet
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single centre, prospective, open label studySingle centre, prospective, open label study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Endometrin 100 mg three times per day (TID)

Women with progesterone levels ≥ 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 100 mg TID until 10th week of pregnancy

Drug: Progesterone Effervescent Vaginal Tablet
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
Other Names:
  • Endometrin

    		•
    Active Comparator: Endometrin 200 mg three times per day (TID)

    Women with progesterone levels < 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 200 mg TID until 10th week of pregnancy

    Drug: Progesterone Effervescent Vaginal Tablet
    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
    Other Names:
  • Endometrin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the ongoing pregnancy rate [6 to 8 weeks after Frozen Embryo Transfer]

      Viability ultrasound

    Secondary Outcome Measures

    1. Evaluate the miscarriage rate [6 to 8 weeks after Frozen Embryo Transfer]

      Viability ultrasound

    2. Evaluate progesterone levels [Before embryo transfer and 10 days after embryo transfer]

      Progesterone levels will be tested at two different times

    3. Evaluate the rate of biochemical pregnancy [10 days after frozen embryo transfer]

      Serum pregnancy test to measure Beta Human Chorionic Gonadotropin (BhCG) levels

    Other Outcome Measures

    1. Blood test to evaluate the prevalence of PIBF [Before embryo transfer and 10 days after embryo transfer]

      Progesterone Inducing Blocking Factor (PIBF) has been found to to have an important part in creating a welcoming environment for the embryo

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique Ovo Montreal Quebec Canada H4P 2S4

    Sponsors and Collaborators

    • Clinique Ovo
    • Ferring Pharmaceuticals

    Investigators

    • Principal Investigator: Wael Jamal, MD, Clinique Ovo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clinique Ovo
    ClinicalTrials.gov Identifier:
    NCT05555121
    Other Study ID Numbers:
    • IIS-1032
    First Posted:
    Sep 26, 2022
    Last Update Posted:
    Dec 27, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Clinique Ovo
    Embryo
    Frozen embryo transfer
    Progesterone
    Embryo implantation
    Additional relevant MeSH terms:
    Infertility
    Progesterone

    Study Results

    No Results Posted as of Dec 27, 2022