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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 weeks
Treatment ~ Varies
Follow Up ~before embryo transfer and 10 days after embryo transfer
This trial's timeline: 3 weeks for screening, Varies for treatment, and before embryo transfer and 10 days after embryo transfer for reporting.

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

Find a Location

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
440,733 Total Patients Enrolled
59 Trials studying Infertility
32,050 Patients Enrolled for Infertility
Wael Jamal, MDPrincipal InvestigatorClinique Ovo
1 Previous Clinical Trials
500 Total Patients Enrolled

Media Library

Progesterone Effervescent Vaginal Tablet (Progestogen) Clinical Trial Eligibility Overview. Trial Name: NCT05555121 — Phase 2
Infertility Research Study Groups: Endometrin 100 mg three times per day (TID), Endometrin 200 mg three times per day (TID)
Infertility Clinical Trial 2023: Progesterone Effervescent Vaginal Tablet Highlights & Side Effects. Trial Name: NCT05555121 — Phase 2
Progesterone Effervescent Vaginal Tablet (Progestogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05555121 — Phase 2
Infertility Patient Testimony for trial: Trial Name: NCT05555121 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the FDA's official stance on Endometrin 100 mg TID?

"While Phase 2 trials do not have data supporting efficacy, there is evidence that Endometrin 100 mg three times per day (TID) is safe. Consequently, our team has given it a safety rating of 2."

Answered by AI

If I wanted to sign up for this experiment, what are the requirements?

"This fertility study is looking for 150 individuals who have had an embryo implanted, and are between 18-42 years old. The key requirements applicants must meet are: being female, falling in the age bracket of 18-42 years old, having a normal uterine cavity (as diagnosed by a physician), being prescribed a FET cycle, either being on their first or second FET cycle, and finally displaying an adequate endometrial pattern with thickness greater than 7 mm after standard endometrial preparation during an artificial cycle."

Answered by AI

Are young adults within the target age range for this research?

"The age requirements to participate in this trial are between 18-42 years old."

Answered by AI

Are there any patients currently being enrolled in this trial?

"No, this study is not looking for additional patients at the moment. However, this could change in the future as the trial's needs evolve. According to clinicaltrials.gov, the first posting was on October 15th 2022 and the most recent update was on September 22nd of that same year. There are currently 271 other trials actively recruiting participants."

Answered by AI

Who else is applying?

What site did they apply to?
Clinique Ovo
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

In my last IVF, my progesterone level was very low. I wonder why and if this was the only cause of the failure.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Rescue Progesterone Supplementation During Frozen Embryo Transfer
2022. "Rescue Progesterone Supplementation During Frozen Embryo Transfer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05555121.
All > Infertility
~73 spots leftby Sep 2025
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