NCT07128394 Extra Luteinizing Hormone Improve Embryo Quality in IVF Patients With Low LH During Long GnRH-Agonist Treatment
| NCT ID | NCT07128394 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanjing University |
| Condition | Infertility, Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 590 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 590 participants in total. It began in 2024-02-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized controlled trial aims to evaluate whether supplementation with exogenous luteinizing hormone (LH) can improve embryo quality in patients undergoing in vitro fertilization (IVF) with a long gonadotropin-releasing hormone agonist (GnRH-a) protocol who have excessive suppression of LH. Eligible participants will be randomly assigned to receive either exogenous LH supplementation or standard care. The primary outcome is embryo quality, and secondary outcomes include pregnancy rates and safety assessments. The study is conducted at Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University.
Eligibility 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.
Contact & Investigator
慧 Jiang, PhD
PRINCIPAL INVESTIGATOR
Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
Frequently Asked Questions
Who can join the NCT07128394 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 37 Years, studying Infertility, Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07128394 currently recruiting?
Yes, NCT07128394 is actively recruiting participants. Contact the research team at jiangyue85@163.com for enrollment information.
Where is the NCT07128394 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07128394 clinical trial?
NCT07128394 is sponsored by Nanjing University. The principal investigator is 慧 Jiang, PhD at Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital. The trial plans to enroll 590 participants.