← Back to Search

Natural vs Programmed Frozen Embryo Transfer for Pregnancy (NatPro Trial)

Q: If a patient is outside the age range for this trial, can they still participate?

You must be 18-41 years old to participate in this trial, which is searching for 36 patients in that age group. There are a total of 140 studies for patients outside of that age range.

Q: What is the long-term safety profile of Programmed cycle?

Programmed cell cycle receives a 3 out of 3 for safety because it is a Phase 3 trial, meaning that, not only is there data supporting its efficacy, but also that there are multiple rounds of data confirming its safety.

Q: What is the largest amount of people who can participate in this research?

From what is available on clinicaltrials.gov, it seems that this trial is still open for recruitment. The listing was created on September 16th 2020 and was last updated on August 2nd, 2022. They are looking for 788 individuals total across 9 different locations.

Q: Are there any still any unfilled vacancies for this clinical research project?

That is correct, the online information specifies that the study is still recruiting individuals. The trial was created on September 16th 2020, and the most recent update was on August 2nd 2022. There are 9 sites in total recruiting 788 patients.

Phase 3

Recruiting

Led By Valerie Baker, MD

Research Sponsored by JHSPH Center for Clinical Trials

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior to enrollment, participant will have at least one vitrified blastocyst with euploid result by pre-implantation genetic testing (PGT-A) or at least one vitrified blastocyst of fair or better morphologic quality if no PGT-A results are available.

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during pregnancy through the post-partum period, according to acog guidelines (typically between 20 weeks gestation and 6 weeks post-delivery)

Awards & highlights

NatPro Trial Summary

This trial is testing whether a natural cycle or a programmed cycle is better for women undergoing frozen embryo transfer.

Who is the study for?

Women aged 18-41 with at least one high-quality or genetically tested blastocyst for IVF, a normal uterine cavity, regular ovulatory cycles, and a BMI <=40. They must be willing to undergo single embryo transfer and randomization to either modified natural or programmed cycle FET. Exclusions include use of donor oocytes, uncontrolled diabetes or hypertension, certain uterine anomalies, and systemic rheumatologic diseases.Check my eligibility

What is being tested?

The NatPro trial is testing two different methods for frozen embryo transfer in IVF: the 'modified natural cycle' which works with the body's own hormones (corpus luteum present), versus the 'programmed cycle' where specific hormones are administered (corpus luteum absent). Women will be randomly assigned to one of these two approaches.See study design

What are the potential side effects?

Potential side effects may include discomfort from hormone injections if assigned to the programmed cycle. Both groups might experience typical IVF-related side effects such as bloating, cramping, mood swings, and tenderness due to hormonal changes.

NatPro Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have at least one healthy embryo frozen for future use.

NatPro Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during pregnancy through the post-partum period, according to acog guidelines (typically between 20 weeks gestation and 6 weeks post-delivery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during pregnancy through the post-partum period, according to acog guidelines (typically between 20 weeks gestation and 6 weeks post-delivery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during pregnancy through the post-partum period, according to acog guidelines (typically between 20 weeks gestation and 6 weeks post-delivery) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Preeclampsia

NatPro Trial Design

2Treatment groups

Active Control

Group I: Programmed cycleActive Control1 Intervention

corpus luteum absent

Group II: Modified natural cycleActive Control1 Intervention

corpus luteum present

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

JHSPH Center for Clinical TrialsLead Sponsor

12 Previous Clinical Trials

9,564 Total Patients Enrolled

Valerie Baker, MDPrincipal InvestigatorDepartment of Gynecology and Obstetrics, Johns Hopkins School of Medicine

2 Previous Clinical Trials

271 Total Patients Enrolled

James Segars, MDPrincipal InvestigatorDepartment of Gynecology and Obstetrics, Johns Hopkins School of Medicine

2 Previous Clinical Trials

189 Total Patients Enrolled

Media Library

Modified natural cycle Clinical Trial Eligibility Overview. Trial Name: NCT04551807 — Phase 3

Pre-eclampsia Research Study Groups: Programmed cycle, Modified natural cycle

Pre-eclampsia Clinical Trial 2023: Modified natural cycle Highlights & Side Effects. Trial Name: NCT04551807 — Phase 3

Modified natural cycle 2023 Treatment Timeline for Medical Study. Trial Name: NCT04551807 — Phase 3

Pre-eclampsia Patient Testimony for trial: Trial Name: NCT04551807 — Phase 3

Frequently Asked Questions

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

If a patient is outside the age range for this trial, can they still participate?

"You must be 18-41 years old to participate in this trial, which is searching for 36 patients in that age group. There are a total of 140 studies for patients outside of that age range."

Answered by AI

What is the long-term safety profile of Programmed cycle?

"Programmed cell cycle receives a 3 out of 3 for safety because it is a Phase 3 trial, meaning that, not only is there data supporting its efficacy, but also that there are multiple rounds of data confirming its safety."

Answered by AI

What is the largest amount of people who can participate in this research?

"From what is available on clinicaltrials.gov, it seems that this trial is still open for recruitment. The listing was created on September 16th 2020 and was last updated on August 2nd, 2022. They are looking for 788 individuals total across 9 different locations."

Answered by AI

Are there any still any unfilled vacancies for this clinical research project?

"That is correct, the online information specifies that the study is still recruiting individuals. The trial was created on September 16th 2020, and the most recent update was on August 2nd 2022. There are 9 sites in total recruiting 788 patients."

Answered by AI

Who else is applying?

What state do they live in?

South Carolina

North Carolina

Montana

How old are they?

18 - 65

What site did they apply to?

Stanford University

University of Oklahoma

Other

Atrium Health

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have had unexplained secondary infertility and think I could be a good candidate for your trial.

PatientReceived no prior treatments

Last year in may me and my husband was informed that i would have to have my tubes removed and the only way for us to have a child would be to have IVF Treatment. We are trying to save up enough to get the IVF.

PatientReceived 1 prior treatment