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

N/ATerminatedNCT04852029

Reproductive Medicine Associates of New Jersey12 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Infertility, Female

Interventions

Low dose hCGOTHER

Patients will either maintain the current dose of have an increased dose prescribed based on randomization

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 46 Years

Medical Language ↔ Plain English

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

Locations (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States

Outcomes

Primary Outcomes

sustained implantation rate

presence of fetal heart beat upon discharge

Time frame: 8 weeks gestational age

Data from ClinicalTrials.gov

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