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

Not Applicable

Terminated

• Conditions: Infertility, Female
• Interventions: Other: Low dose hCG

• Registration Number: NCT04852029
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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.

Study Timeline

• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-21
• Study Start: 2021-08-16
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Low dose hCG	to remain on current dose of low dose hCG
Intervention Group	Low dose hCG	increased dose of low dose hCG prescribed

Primary Outcome Measures

Name	Time	Method
sustained implantation rate	8 weeks gestational age	presence of fetal heart beat upon discharge

Trial Locations

Locations (1)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States