Extra luteinizing hormone for embryo quality in women with low LH during IVF

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with infertility having IVF/ICSI with a long GnRH agonist protocol, whose LH level becomes very low. It tests whether adding LH improves embryo quality.

Age

20 to 37 years

Sex

Women only

Disease stage

Infertility treated with IVF/ICSI using the long-acting GnRH agonist protocol. Normal womb cavity, checked by hysteroscopy, sonohysterography or hysterosalpingography within 6 months.

Earlier treatment

Must be having the long-acting GnRH agonist protocol. People with a history of ovarian surgery cannot join.

Biomarker or test result

Blood LH level <0.5 U/L after pituitary downregulation.

Main reasons for not taking part

• Polycystic ovary syndrome (PCOS), endometriosis or adenomyosis
• Repeated failure of embryos to implant (RIF)
• Ovarian cysts ≥3 cm (1.2 in) or suspected cancer; history of ovarian surgery
• Low egg reserve (antral follicle count <5, anti-Müllerian hormone <1.1 ng/mL, or baseline FSH >10 IU/L)
• Chromosome changes in either partner, or uncontrolled high blood pressure, diabetes, thyroid or autoimmune disease

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 20 and 37 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• Recombinant LH Supplementation GroupTreatment being tested

  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.

  Treatment: Recombinant Luteinizing Hormone (rLH), Recombinant Follicle-Stimulating Hormone (rFSH), and Gonadotropin-Releasing Hormone Agonist (GnRH-a)

• Conventional rFSH-Only GroupExisting treatment, for comparison

  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.

  Treatment: Recombinant Follicle-Stimulating Hormone (rFSH) and Gonadotropin-Releasing Hormone Agonist (GnRH-a)