Status:
TERMINATED
Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes
Lead Sponsor:
Reproductive Medicine Associates of New Jersey
Conditions:
Infertility, Female
Eligibility:
FEMALE
18-46 years
Phase:
NA
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 ...
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 prede...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04852029
Start Date
August 16 2021
End Date
December 31 2021
Last Update
January 28 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920