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Recruiting NCT07128394

Extra Luteinizing Hormone Improve Embryo Quality in IVF Patients With Low LH During Long GnRH-Agonist Treatment

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Trial Parameters

Condition Infertility, Female
Sponsor Nanjing University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 590
Sex FEMALE
Min Age 20 Years
Max Age 37 Years
Start Date 2024-02-01
Completion 2026-09-30
Interventions
Recombinant Luteinizing Hormone (rLH)Recombinant Follicle-Stimulating Hormone (rFSH)Gonadotropin-Releasing Hormone Agonist (GnRH-a)

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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 stimula

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