Programmed cycle for Pre-eclampsia

Yale, Orange, CT

Targeting 2 different conditionsProgrammed cycle +1 morePhase 3RecruitingLed by Valerie Baker, MDResearch 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

Regular menstrual cycle length (approximately 24-35 days) indicative of ovulatory cycles.

Willing to undergo elective single embryo transfer

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Study Summary

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

Eligible Conditions

Pre-eclampsia
Pregnancy

Eligibility Criteria

Inclusion Criteria

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

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You have regular periods that happen every 24-35 days, which means you are likely ovulating.

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You agree to only have one embryo transferred during the fertility treatment.

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Your body mass index (BMI) is less than or equal to 40.

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

JHSPH Center for Clinical TrialsLead Sponsor

10 Previous Clinical Trials

2,599 Total Patients Enrolled

Valerie Baker, MDPrincipal Investigator

Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine

2 Previous Clinical Trials

271 Total Patients Enrolled

James Segars, MDPrincipal Investigator

Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine

1 Previous Clinical Trials

39 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