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Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes

Primary Purpose

Infertility, Female

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low dose hCG
Sponsored by
Reproductive Medicine Associates of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility, Female

Eligibility Criteria

18 Years - 46 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients whose physicians plan to prescribe low-dose hCG for ovarian stimulation
  2. Age 18-46
  3. Negative serum hCG prior to start of COH
  4. BMI >18 and <35
  5. Plan for ejaculated sperm use
  6. Plan for PGT testing with euploid embryo transfer

Exclusion Criteria:

  1. Administration of low-dose hCG during frozen embryo transfer cycle
  2. Concomitant Menopur administration during ovarian stimulation or during frozen embryo transfer cycle
  3. BMI <18 or >35
  4. Age <18 or >46
  5. Presence of hydrosalpinxes that communicate with the endometrial cavity
  6. Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), and persistent endometrial fluid
  7. Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum)
  8. Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
  9. Use of surgical procedures to obtain sperm
  10. Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking)
  11. Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)
  12. Declination of PGT testing

Sites / Locations

  • Reproductive Medicine Associates of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

to remain on current dose of low dose hCG

increased dose of low dose hCG prescribed

Outcomes

Primary Outcome Measures

sustained implantation rate
presence of fetal heart beat upon discharge

Secondary Outcome Measures

Full Information

First Posted
April 15, 2021
Last Updated
January 13, 2022
Sponsor
Reproductive Medicine Associates of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT04852029
Brief Title
Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes
Official Title
Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
recruitment issues
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive Medicine Associates of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to determine the effect of tailoring dosage of low-dose hCG secondary to serum hCG levels during IVF ovarian stimulation on sustained implantation rates of preimplantation genetically tested euploid embryos.
Detailed Description
The objective of this study is to conduct a double-blind prospective randomized control trial to determine if individualized hCG titration based on a patient's serum hCG level above or below the predetermined serum hCG level improves IVF outcomes, primarily sustained implantation rates. Patients who fall below the desired serum hCG threshold will be randomized to either maintaining their current dose of low dose hCG or being increased.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
to remain on current dose of low dose hCG
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
increased dose of low dose hCG prescribed
Intervention Type
Other
Intervention Name(s)
Low dose hCG
Intervention Description
Patients will either maintain the current dose of have an increased dose prescribed based on randomization
Primary Outcome Measure Information:
Title
sustained implantation rate
Description
presence of fetal heart beat upon discharge
Time Frame
8 weeks gestational age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients whose physicians plan to prescribe low-dose hCG for ovarian stimulation Age 18-46 Negative serum hCG prior to start of COH BMI >18 and <35 Plan for ejaculated sperm use Plan for PGT testing with euploid embryo transfer Exclusion Criteria: Administration of low-dose hCG during frozen embryo transfer cycle Concomitant Menopur administration during ovarian stimulation or during frozen embryo transfer cycle BMI <18 or >35 Age <18 or >46 Presence of hydrosalpinxes that communicate with the endometrial cavity Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), and persistent endometrial fluid Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum) Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable) Use of surgical procedures to obtain sperm Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking) Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat) Declination of PGT testing
Facility Information:
Facility Name
Reproductive Medicine Associates of New Jersey
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes

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