Adding luteinizing hormone to improve embryo quality for IVF patients with very low LH on a long GnRH‑agonist protocol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial enrolls women aged 20–37 undergoing IVF with a long GnRH‑agonist protocol who demonstrate profound LH suppression (serum LH <0.5 U/L) after downregulation. Participants are randomly assigned to receive exogenous recombinant LH in addition to standard recombinant FSH stimulation or to receive standard care without LH supplementation. The primary endpoint is the proportion of high‑quality embryos per cycle, with secondary endpoints including clinical pregnancy rate, implantation rate, live birth rate, and safety outcomes such as OHSS and adverse events. The single‑center study is conducted at Nanjing Drum Tower Hospital, Nanjing University Medical School.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanjing Drum Tower Hospital, Nanjing University Medical School
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: 慧 Jiang, PhD — Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
• Study coordinator: Yue Jiang, PhD
• Email: jiangyue85@163.com
• Phone: +8613814122872

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.