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

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

Must not have

Mullerian uterine anomaly, if not correctable

Uncontrolled hypertension

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

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a uterine condition that cannot be fixed with surgery.

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My high blood pressure is not under control.

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I have an untreated hydrosalpinx.

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I have a condition that affects my immune system and requires ongoing medication.

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My diabetes is not well-controlled.

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I am not allergic or unable to take medications needed for embryo transfer.

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.