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

Reproductive Medicine Associates of New Jersey

Status: Terminated

Conditions: Infertility, Female

Treatments: Other: Low dose hCG

Study type: Interventional

Funder types: Other

Identifiers

NCT04852029

RMA-2021-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 46 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups

Control Group

Active Comparator group

Description:

to remain on current dose of low dose hCG

Treatment:

Other: Low dose hCG

Intervention Group

Experimental group

Description:

increased dose of low dose hCG prescribed

Treatment:

Other: Low dose hCG