Endometrial Rejuvenation Study

NCT04045821 | Terminated

• 1 other identifier: RMA-2019-02
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

Brief Summary

To evaluate the response of the endometrial lining after subcutaneous administration of the medication AMD3100. This medication mobilizes stem cells and will be used in a population of infertile women with a thin endometrium who are undergoing frozen-thawed embryo transfer. The investigators will assess associations between response to stem cell mobilization and pregnancy outcomes.

Conditions

Infertility of Uterine Origin

Outcome Measures

Primary Outcomes (1)

• Endometrial thickness

  measurement of endometrial thickness

  measured on day prior to progesterone initiation during frozen embryo transfer cycle

Secondary Outcomes (4)

• number of participants with a chemical pregnancy

  9-11 days post embryo transfer

• number of participants with a clinical pregnancy

  seen as early as 18 days post embryo transfer

• number of participants with a live births

  typically 9 months from embryo transfer

• endometrial volume

  measured at baseline visit during cycle 1 (one month) and after progesterone initiation during cycle 4 (one month)

Study Arms (2)

Control

PLACEBO COMPARATOR

Patients in this arm will not receive the study drug. A placebo of normal saline will be injected subcutaneously and the D\&C procedure will be completed.

Drug: Normal saline; Procedure: dilation and curettage

Intervention

EXPERIMENTAL

Patients in this arm will receive a dose of the study drug, AMD3100, injected subcutaneously and the D\&C procedure will be completed.

Drug: AMD3100; Procedure: dilation and curettage

Interventions

AMD3100 DRUG

Subjects in this arm will have AMD3100 administered per the standard dosing regimen of 0.24 mg/kg actual body weight subcutaneous x1 dose

Intervention

Normal saline DRUG

Subjects in this arm will have a placebo of normal saline administered subcutaneously x1 dose

Control

dilation and curettage PROCEDURE

all participants will undergo routine D\&C procedure

Also known as: D&C

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: all participants must be biologically female and possess a uterus
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients planning to undergo a frozen-thawed embryo transfer cycle using a single euploid blastocyst.
• Patients who have previously undergone at least 2 unsuccessful frozen-thawed embryo transfer cycles, defined as failure to achieve a 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 6 mm maximum thickness) during at least one prior unsuccessful embryo transfer cycle.
• Initiation of the most recent unsuccessful frozen-thawed embryo transfer cycle with a thin endometrial lining must have occurred after January 1, 2017.

You may not qualify if:

• Fewer than 2 prior unsuccessful frozen-thawed embryo transfer cycles.
• Most recent unsuccessful frozen-thawed embryo transfer prior to January 1, 2017.
• No euploid embryos available for transfer.
• Mullerian anomalies, excluding arcuate uterus
• Submucosal fibroids
• History of uterine surgery, excluding polypectomy, D\&C, and Cesarean section
• Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
• Failure of patient to agree to enrollment in study with written consent.
• History of drug sensitivity or adverse reaction to AMD3100 (plerixafor).
• Pregnancy

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead

Study Sites (3)

Reproductive Medicine Associates of Northern California

San Francisco, California, 94105, United States

Location

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Reproductive Medicine Associates of Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

plerixafor; Saline Solution; Dilatation and Curettage

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Brent Hanson, MD

  Reproductive Medicine Associates of New Jersey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 6, 2019
• Study Start: January 17, 2020
• Primary Completion: January 27, 2021
• Study Completion: May 4, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)