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

NCT04852029 | Terminated

• 1 other identifier: RMA-2021-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• sustained implantation rate

  presence of fetal heart beat upon discharge

  8 weeks gestational age

Study Arms (2)

Control Group

ACTIVE COMPARATOR

to remain on current dose of low dose hCG

Other: Low dose hCG

Intervention Group

EXPERIMENTAL

increased dose of low dose hCG prescribed

Other: Low dose hCG

Interventions

Low dose hCG OTHER

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

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 21, 2021
• Study Start: August 16, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)