Platelet Rich Plasma for Insufficient Endometrium
ConditionInfertility of Uterine Origin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorReproductive Medicine Associates of New Jersey
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Platelet Rich Plasma Intrauterine infusion
Other interventionan intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants
Normal saline Intrauterine infusion
Other interventionan intrauterine infusion of normal saline will be administered to this group of participants
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupActive comparator 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Endometrial Thickness during frozen embryo transfer
peak endometrial thickness prior to initiation of progesterone
Time frame
during the proliferative phase of the frozen embryo transfer cycleSecondary outcomes
1
Sustained implantation rate
presence of fetal heart beat upon discharge from care
Time frame
approximately 9 weeks gestational ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov