Infertility of Uterine Origin
Conditions
Brief summary
To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.
Detailed description
Patients with a history of thin endometrium will be randomized to either an intrauterine infusion of PRP vs. a placebo infusion of normal saline. This is a double-blind, placebo controlled prospective RCT. Patients will then proceed with a frozen embryo transfer of a single euploid embryo per routine.
Interventions
an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants
OTHERNormal saline Intrauterine infusion
an intrauterine infusion of normal saline will be administered to this group of participants
Sponsors
Reproductive Medicine Associates of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have previously undergone at least 2 unsuccessful frozen embryo transfer cycles, defined as failure to achieve a sustained clinical pregnancy (visualization of intrauterine gestational sac on ultrasound or a cancelled embryo transfer cycle due to inadequate endometrial thickness * Patients with a diagnosis of thin endometrial lining (less than or equal to 6 mm maximum thickness) during prior unsuccessful or canceled embryo transfer cycles.
Exclusion criteria
* Fewer than 2 prior unsuccessful or canceled frozen embryo transfer cycles. * Most recent unsuccessful embryo transfer prior to January 1, 2017. * Mullerian anomalies, excluding arcuate uterus * Concurrent submucosal fibroids, unrepaired uterine defects or present indication for uterine surgery * Communicating hydrosalpinx without plans for surgical correction prior to study enrollment. * Failure of patient to agree to enrollment in study with written consent. * Concurrent pregnancy * Anticoagulation use for which plasma infusion is contraindicated * History of thrombosis * Thrombophilia either inherited or acquired * Concomitant use of adjunctive therapies for proliferation. These must be discontinued upon enrollment. * Embryo planned to be used for transfer generated from surgically obtained sperm due to a diagnosis of non-obstructive azoospermia * Recurrent/persistent endometrial fluid in prior cycles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial Thickness during frozen embryo transfer | during the proliferative phase of the frozen embryo transfer cycle | peak endometrial thickness prior to initiation of progesterone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained implantation rate | approximately 9 weeks gestational age | presence of fetal heart beat upon discharge from care |
Countries
United States
Contacts
CONTACTChristine V Whitehead, BSN, RN
CONTACTCaroline Zuckerman, BS
Outcome results
None listed