RECRUITING

Platelet Rich Plasma for Insufficient Endometrium

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Conditions

Infertility of Uterine Origin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Intrauterine Platelet Rich Plasma (PRP) Infusion for Endometrial Insufficiency: A Prospective, Double-Blind, Placebo-Controlled Randomized Controlled Trial

Quick Facts

Study Start:2022-10-15
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05538338

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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.
  1. * Fewer than 2 prior unsuccessful or canceled frozen embryo transfer cycles.
  2. * Most recent unsuccessful embryo transfer prior to January 1, 2017.
  3. * Mullerian anomalies, excluding arcuate uterus
  4. * Concurrent submucosal fibroids, unrepaired uterine defects or present indication for uterine surgery
  5. * Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
  6. * Failure of patient to agree to enrollment in study with written consent.
  7. * Concurrent pregnancy
  8. * Anticoagulation use for which plasma infusion is contraindicated
  9. * History of thrombosis
  10. * Thrombophilia either inherited or acquired
  11. * Concomitant use of adjunctive therapies for proliferation. These must be discontinued upon enrollment.
  12. * Embryo planned to be used for transfer generated from surgically obtained sperm due to a diagnosis of non-obstructive azoospermia
  13. * Recurrent/persistent endometrial fluid in prior cycles

Contacts and Locations

Study Contact

Christine V Whitehead, BSN, RN
CONTACT
19736562841
clinicalresearchteam@ivirma.com
Caroline Zuckerman, BS
CONTACT
19736562841
clinicalresearchteam@ivirma.com

Study Locations (Sites)

Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
United States

Collaborators and Investigators

Sponsor: Reproductive Medicine Associates of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-15
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-10-15
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Infertility of Uterine Origin