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Progestogen
Progesterone Supplementation for Frozen Embryo Transfer (P4R Trial)
Phase 2
Waitlist Available
Led By Wael Jamal, MD
Research Sponsored by Clinique Ovo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days after frozen embryo transfer
Awards & highlights
P4R Trial Summary
This trial is a dose-response study of Endometrin, a progesterone supplement, during in vitro fertilization (IVF). The usual dose of Endometrin is 100 mg two to three times per day. 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. The hypothesis is that a woman with low progesterone levels would benefit from a higher dose of Endometrin. PIBF (Progesterone Induced Blocking Factor) levels, a protein found in the blood that could also predict
Who is the study for?
This trial is for women aged 18-42 undergoing their first or second frozen embryo transfer (FET) with a normal uterine cavity and adequate endometrial thickness. It's not for those with uterine abnormalities, cancer, certain drug use, gastrointestinal issues, thromboembolism history, severe organ disease, allergies to NSAIDs or progesterone components.Check my eligibility
What is being tested?
The study tests if adjusting the dose of Endometrin based on blood progesterone levels improves pregnancy chances in IVF. Women with low progesterone may receive a higher dose (600 mg), while others continue the standard (300 mg). The research also examines PIBF levels as potential predictors of IVF success.See study design
What are the potential side effects?
Possible side effects from Endometrin include local irritation or inflammation at the site of insertion, headaches, breast tenderness, mood swings and cramping. Some individuals might experience allergic reactions if sensitive to the medication's ingredients.
P4R Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before embryo transfer and 10 days after embryo transfer
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before embryo transfer and 10 days after embryo transfer
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the ongoing pregnancy rate
Secondary outcome measures
Evaluate progesterone levels
Evaluate the miscarriage rate
Evaluate the rate of biochemical pregnancy
Other outcome measures
Hematologic Tests
P4R Trial Design
2Treatment groups
Active Control
Group I: Endometrin 100 mg three times per day (TID)Active Control1 Intervention
Women with progesterone levels ≥ 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 100 mg TID until 10th week of pregnancy
Group II: Endometrin 200 mg three times per day (TID)Active Control1 Intervention
Women with progesterone levels < 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 200 mg TID until 10th week of pregnancy
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Who is running the clinical trial?
Clinique OvoLead Sponsor
31 Previous Clinical Trials
41,357 Total Patients Enrolled
18 Trials studying Infertility
8,057 Patients Enrolled for Infertility
Ferring PharmaceuticalsIndustry Sponsor
314 Previous Clinical Trials
440,735 Total Patients Enrolled
59 Trials studying Infertility
32,052 Patients Enrolled for Infertility
Wael Jamal, MDPrincipal InvestigatorClinique Ovo
1 Previous Clinical Trials
500 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with porphyria.I have or had serious blood clot issues.I am prescribed a cycle with FET substitution.My uterus lining is thick enough for treatment after preparation.I have experienced vaginal bleeding that has not been diagnosed.I have a current or past stomach ulcer, or a bleeding disorder.I am a woman aged between 18 and 42.I am in my first or second cycle of FET (frozen embryo transfer).My doctor says my uterine cavity is normal.I have G6PD deficiency.I have severe liver problems.I have or might have breast or genital tract cancer.I am taking methotrexate at doses of 15mg/week or more.I do not have severe kidney disease or heart failure.My fertility treatment is tailored based on endometrial receptivity tests.My doctor confirmed I have uterine abnormalities that prevent me from having a frozen embryo transfer.
Research Study Groups:
This trial has the following groups:- Group 1: Endometrin 100 mg three times per day (TID)
- Group 2: Endometrin 200 mg three times per day (TID)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Infertility Patient Testimony for trial: Trial Name: NCT05555121 — Phase 2
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