Adding luteinizing hormone to improve embryo quality for IVF patients with very low LH on a long GnRH‑agonist protocol
Exogenous Luteinizing Hormone Supplementation to Improve Embryo Quality in Patients With Excessive LH Suppression During a Long GnRH-Agonist Protocol: A Randomized Controlled Trial
This trial will test whether adding extra luteinizing hormone during ovarian stimulation helps improve embryo quality for women undergoing IVF who have very low LH after long GnRH‑agonist suppression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 590 (estimated) |
| Ages | 20 Years to 37 Years |
| Sex | Female |
| Sponsor | Nanjing University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07128394 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 20–37 undergoing IVF/ICSI with a long GnRH‑agonist protocol who have serum LH <0.5 U/L after pituitary downregulation and a normal uterine cavity are ideal candidates.
Not a fit: Patients with PCOS, poor ovarian reserve, recurrent implantation failure, significant uterine pathology, or systemic contraindications (all excluded) are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, supplementing LH could increase the number of high‑quality embryos and potentially improve pregnancy and live birth rates for women with profound LH suppression during stimulation.
How similar studies have performed: Previous smaller trials and observational studies on LH supplementation have produced mixed results, so randomized data in this specifically LH‑suppressed population remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.