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

NCT ID: NCT04852029

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2021-12-31

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.

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Control Group

to remain on current dose of low dose hCG

Group Type: ACTIVE_COMPARATOR

Low dose hCG

Intervention Type: OTHER

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

Intervention Group

increased dose of low dose hCG prescribed

Group Type: EXPERIMENTAL

Low dose hCG

Intervention Type: OTHER

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

Interventions

Low dose hCG

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States

Countries

United States

Other Identifiers

RMA-2021-01

Identifier Type: -

Identifier Source: org_study_id