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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04852029
• Other study ID #: RMA-2021-01
• Status: Terminated
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 46 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Other:
• Low dose hCG
Patients will either maintain the current dose of have an increased dose prescribed based on randomization

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sustained implantation rate	presence of fetal heart beat upon discharge	8 weeks gestational age