Trial record 1 of 1 for:
NatPro
Natural Versus Programmed Frozen Embryo Transfer (NatPro) (NatPro)
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| ClinicalTrials.gov Identifier: NCT04551807 |
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Recruitment Status :
Recruiting
First Posted : September 16, 2020
Last Update Posted : August 4, 2022
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Sponsor:
JHSPH Center for Clinical Trials
Information provided by (Responsible Party):
JHSPH Center for Clinical Trials
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Brief Summary:
NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing frozen embryo transfer (FET) will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pregnancy Related Pre-Eclampsia | Procedure: Modified natural cycle Procedure: Programmed cycle | Phase 3 |
NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing FET will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent). The study will implement a stratified randomization design to balance the use of pre-implantation genetic testing (PGT) across the two treatment arms. Each participant will have up to 3 FET cycles until live birth occurs, or the participant has no embryos available for transfer. Primary endpoints will be the proportion of women experiencing preeclampsia comparing modified natural to programmed FET among women with viable pregnancy (defined as pregnancy lasting at least 20 weeks) and the cumulative proportion of women having live births in the two arms.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 788 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Multi-center, Parallel-group, Randomized Controlled Trial of Modified Natural Versus Programmed Cycles for Frozen Embryo Transfers and Their Association With Preeclampsia and Live Births |
| Actual Study Start Date : | September 16, 2020 |
| Estimated Primary Completion Date : | April 1, 2024 |
| Estimated Study Completion Date : | September 30, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Modified natural cycle
corpus luteum present
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Procedure: Modified natural cycle
This treatment protocol is defined as a modified natural cycle as the participant will be instructed to (1) administer human chorionic gonadotropin (hCG) to assist with timing of the embryo transfer and (2) supplement the luteal phase with a low dose of progesterone. |
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Active Comparator: Programmed cycle
corpus luteum absent
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Procedure: Programmed cycle
This protocol is designated as programmed because the endometrial development occurs only in association with administration of estradiol and progesterone. No ovulation occurs due to suppression of follicle development by the estradiol and the timing of the transfer is based on the number of days elapsed following initiation of exogenous progesterone. |
Primary Outcome Measures :
- Preeclampsia [ Time Frame: During pregnancy through the post-partum period, according to ACOG guidelines (typically between 20 weeks gestation and 6 weeks post-delivery) ]Frequency of preeclampsia, as defined by American College of Obstetricians and Gynecologists (ACOG) guidelines for hypertensive disorders in pregnancy (Obstetrics & Gynecology 2020;135:e237-e260)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 41 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Women attempting to get pregnant using frozen embryos |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria
To be eligible, subjects must meet all these criteria:
- Age 18-39 years at the time that embryos were created if no PGT testing was performed. If PGT testing was performed and indicates that an embryo is euploid, the patient can be included if she was age 18-41 years at the time that the embryo was created.
- Age 18-41 years at the time of randomization as advancing age itself becomes a significant risk for preeclampsia
- Normal uterine cavity as assessed by saline infusion sonohysterogram, hysterosalpingogram, or hysteroscopy within one year of the enrollment visit, and repeated at the discretion of the investigator
- Regular menstrual cycle length (approximately 24-35 days) indicative of ovulatory cycles.
- Willing to undergo elective single embryo transfer
- Body Mass Index <=40
- If Body Mass Index is over 30 or individual has other risk factors for diabetes, normal hemoglobin A1C
- 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.
- Willingness to be randomized to either a modified natural or programmed cycle, with a willingness to administer intramuscular progesterone in oil if assigned to the programmed cycle.
- Normal thyroid stimulating hormone (TSH), according to local laboratory standards (or TSH level with a clinically insignificant abnormality per the site director), within one year of study enrollment and repeated at the discretion of the investigator. Use of thyroid medication is permitted.
Exclusion criteria
To be eligible, subjects must not meet any one of these criteria:
- Medical contraindication to pregnancy
- Embryos created using donor oocytes
- Embryo donation
- Gestational carrier
- Reciprocal IVF (one female partner carrying pregnancy, other female partner as source of eggs)
- Fresh embryos created from frozen oocytes. Patients with frozen embryos created from frozen oocytes can be included.
- Recurrent implantation failure defined as no clinical pregnancy with ≥ 2 prior consecutive embryo transfers unless patient also had successful live birth between or after the failed embryo transfers
- Anti-phospholipid antibody syndrome or rheumatologic disease requiring chronic systemic medications
- Uncontrolled diabetes mellitus
- History of >1 pregnancy loss in the second or third trimester
- Uncontrolled hypertension
- Untreated hydrosalpinx (i.e., hydrosalpinx in situ which has not been ligated or removed)
- Mullerian uterine anomaly, if not correctable
- Physician recommendation to perform the embryo transfer outside of the timing specified by the protocol
- Contraindication to any medication which must be used in preparation for the frozen embryo transfer (i.e., estradiol, progesterone, hCG)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551807
Contacts
| Contact: David Shade, JD | 410-955-8175 | dshade@jhmi.edu |
Locations
| United States, California | |
| Stanford University | Recruiting |
| Sunnyvale, California, United States, 94087 | |
| Contact: Alma Gonzalez 408-688-9892 agonlez@stanford.edu | |
| Principal Investigator: Ruth Lathi, MD | |
| United States, Maryland | |
| Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21093 | |
| Contact: Mindy Christianson, MD 410-583-2761 mchris21@jhmi.edu | |
| Contact: Bhuchitra Singh 4106142000 bsingh10@jhmi.edu | |
| Principal Investigator: Mindy Christianson, MD | |
| Shady Grove Fertility | Recruiting |
| Rockville, Maryland, United States, 20850 | |
| Contact: Clinical Research Team 301-545-1423 sgfclinicalresearchteam@sgfertility.com | |
| Contact: Tasha Newsome 301-545-1289 Tasha.Newsome@sgfertility.com | |
| Principal Investigator: Kate Devine, MD | |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Lynda Kochman 585-275-0250 lynda_kochman@urmc.rochester.edu | |
| Principal Investigator: Wendy Vitek, MD | |
| United States, North Carolina | |
| Atrium Health | Recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Contact: Mary Andrews 704-953-4832 mary.andrews@atriumhealth.org | |
| Contact: Gretchen Hoelscher gretchen.hoelscher@atriumhealth.org | |
| Principal Investigator: Rebecca Usadi, MD | |
| United States, Oklahoma | |
| University of Oklahoma | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Michelle Starkey-Scruggs 405-271-9204 Michelle-StarkeyScruggs@ouhsc.edu | |
| Principal Investigator: Karl Hansen, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Andrea Morley 215-615-4202 Andrea.Morley@pennmedicine.upenn.edu | |
| Principal Investigator: Christos Coutifaris | |
| United States, Texas | |
| CARE Fertility | Recruiting |
| Bedford, Texas, United States, 76022 | |
| Contact: Aracely Casillas 817-540-1157 aracelyc@embryo.net | |
| Principal Investigator: Kevin Doody, MD | |
| United States, West Virginia | |
| West Virginia University Center for Reproductive Medicine | Recruiting |
| Morgantown, West Virginia, United States, 26505 | |
| Contact: Karen Merryweather 304-598-3100 merrymank@wvumedicine.org | |
| Principal Investigator: Ryan Heitmann, MD | |
Sponsors and Collaborators
JHSPH Center for Clinical Trials
Investigators
| Principal Investigator: | Valerie Baker, MD | Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine | |
| Principal Investigator: | James Segars, MD | Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | JHSPH Center for Clinical Trials |
| ClinicalTrials.gov Identifier: | NCT04551807 |
| Other Study ID Numbers: |
IRB00214688 |
| First Posted: | September 16, 2020 Key Record Dates |
| Last Update Posted: | August 4, 2022 |
| Last Verified: | August 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by JHSPH Center for Clinical Trials:
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frozen embryo transfer infertility in vitro fertilization |
Additional relevant MeSH terms:
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Eclampsia Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications |