Recruiting

ELH-IVFExogenous Luteinizing Hormone for Improving Embryo Quality in IVF with Excessive LH Suppression

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What is being tested

Recombinant Luteinizing Hormone (rLH)

+ Recombinant Follicle-Stimulating Hormone (rFSH)

+ Gonadotropin-Releasing Hormone Agonist (GnRH-a)

Drug
Who is being recruted

Urogenital Diseases+4

+ Genital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

From 20 to 37 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2024
See protocol details

Summary

Principal SponsorNanjing University
Study ContactYue Jiang, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleExogenous Luteinizing Hormone Supplementation to Improve Embryo Quality in Patients With Excessive LH Suppression During a Long GnRH-Agonist Protocol: A Randomized Controlled Trial
NCT07128394
Principal SponsorNanjing University
Study ContactYue Jiang, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

590 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleInfertilityInfertility, FemaleFemale Urogenital Diseases

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants receive controlled ovarian hyperstimulation (COH) using a long-acting GnRH agonist (triptorelin 3.75 mg) for pituitary downregulation, followed by recombinant FSH (rFSH) combined with recombinant LH (rLH) at a ratio of 2:1 starting on stimulation day. rLH administration continues throughout the stimulation phase, with gonadotropin doses adjusted based on follicular growth and hormone monitoring. Trigger is given when 2-3 leading follicles reach ≥18 mm, followed by oocyte retrieval, IVF/ICSI, and embryo quality assessment.

Group II

Active Comparator
Participants receive the same long-acting GnRH agonist downregulation and rFSH stimulation protocol as the experimental arm, but without rLH supplementation. Only rFSH is used during COH, with dose adjustments according to follicular development and hormone levels. Trigger, oocyte retrieval, IVF/ICSI, and embryo assessment follow the same procedures as in the experimental arm.

Study 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

Recruiting

Nanjing Drum Tower Hospital, Nanjing University Medical School

Nanjing, ChinaOpen Nanjing Drum Tower Hospital, Nanjing University Medical School in Google Maps
Recruiting
One Study Center