Phase
Condition
Pregnancy Complications
Treatment
Programmed cycle
Modified natural cycle
Clinical Study ID
Ages 18-41 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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)
Study Design
Study Description
Connect with a study center
University of California San Francisco
San Francisco, California 94158
United StatesSite Not Available
Stanford University
Sunnyvale, California 94087
United StatesSite Not Available
Yale
Orange, Connecticut 06477
United StatesSite Not Available
Fertility Institute of Hawaii
Honolulu, Hawaii 96814
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Johns Hopkins
Baltimore, Maryland 21093
United StatesSite Not Available
Shady Grove Fertility
Rockville, Maryland 20850
United StatesSite Not Available
Boston IVF
Waltham, Massachusetts 02451
United StatesSite Not Available
University of Rochester
Rochester, New York 14642
United StatesSite Not Available
Atrium Health
Charlotte, North Carolina 28203
United StatesSite Not Available
Cleveland Clinic Foundation
Beachwood, Ohio 44122
United StatesSite Not Available
University of Oklahoma
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
CARE Fertility
Bedford, Texas 76022
United StatesSite Not Available
West Virginia University Center for Reproductive Medicine
Morgantown, West Virginia 26505
United StatesSite Not Available
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