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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Female

Intervention / Treatment
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* Other: Low dose hCG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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