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

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.

Study Overview

• Status: Terminated
• Conditions: Infertility, Female
• Intervention / Treatment: Other: Low dose hCG

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; to remain on current dose of low dose hCG	Other: Low dose hCG; Patients will either maintain the current dose of have an increased dose prescribed based on randomization
Experimental: Intervention Group; increased dose of low dose hCG prescribed	Other: Low dose hCG; Patients will either maintain the current dose of have an increased dose prescribed based on randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sustained implantation rate	presence of fetal heart beat upon discharge	8 weeks gestational age

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: RMA-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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