ELH-IVFExogenous Luteinizing Hormone for Improving Embryo Quality in IVF with Excessive LH Suppression
Recombinant Luteinizing Hormone (rLH)
+ Recombinant Follicle-Stimulating Hormone (rFSH)
+ Gonadotropin-Releasing Hormone Agonist (GnRH-a)
Urogenital Diseases+4
+ Genital Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: February 1, 2024
Actual date on which the first participant was enrolled.This study focuses on finding ways to improve embryo quality for women undergoing in vitro fertilization (IVF) who experience excessive suppression of a hormone called luteinizing hormone (LH) during their treatment. LH is important for the final stages of egg development and ovulation, and when its levels are too low during IVF, it may negatively affect the quality of embryos. The study specifically targets women who meet certain criteria for low LH levels before or during their IVF stimulation process. The goal is to determine if adding extra LH to their treatment can enhance embryo quality, potentially leading to better pregnancy outcomes. Participants in the study are randomly divided into two groups. One group receives the usual ovarian stimulation treatment without any changes, while the other group gets additional LH along with their standard treatment. The study will compare the number of high-quality embryos produced in each group. Researchers will also look at other outcomes like pregnancy rates, the success of embryo implantation, live birth rates, and monitor any safety concerns such as the development of ovarian hyperstimulation syndrome (OHSS). By gathering this information, the study aims to improve IVF protocols and help women achieve better reproductive results.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.590 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 20 to 37 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Women aged 20 to 37 years (inclusive). Diagnosed with infertility and undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment using the long-acting GnRH agonist protocol. Serum luteinizing hormone (LH) level \<0.5 U/L after pituitary downregulation. Normal uterine cavity as confirmed by hysteroscopy, sonohysterography, or hysterosalpingography within 6 months. Written informed consent provided prior to participation. Exclusion Criteria: * Polycystic ovary syndrome (PCOS). History of recurrent implantation failure (RIF). Presence of endometriosis or adenomyosis. History of ovarian surgery. Ovarian cysts ≥3 cm or with suspected malignancy. Poor ovarian reserve (antral follicle count \<5, anti-Müllerian hormone \<1.1 ng/mL, or baseline FSH \>10 IU/L). Chromosomal abnormalities in either partner. Systemic diseases such as uncontrolled hypertension, diabetes, thyroid disorders, or autoimmune diseases. Contraindications to ovarian stimulation medications or pregnancy.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Nanjing Drum Tower Hospital, Nanjing University Medical School
Nanjing, ChinaOpen Nanjing Drum Tower Hospital, Nanjing University Medical School in Google Maps