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

ConditionsInfertility, FemaleLuteinizing Hormone (LH)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-37
SponsorNanjing University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Recombinant Luteinizing Hormone (rLH)

    Drug

    Recombinant LH administered subcutaneously in combination with recombinant FSH (rFSH) at a ratio of 2:1 starting on stimulation day, continued throughout controlled ovarian hyperstimulation. Dosage adjusted according to follicular growth and serum hormone levels.

  • Recombinant Follicle-Stimulating Hormone (rFSH)

    Drug

    Recombinant FSH administered subcutaneously for controlled ovarian hyperstimulation after pituitary downregulation with a long-acting GnRH agonist. Dosage adjusted based on follicular development and hormone monitoring.

  • Gonadotropin-Releasing Hormone Agonist (GnRH-a)

    Drug

    Long-acting GnRH agonist (3.75 mg) administered subcutaneously on menstrual cycle day 2-4 for pituitary downregulation before controlled ovarian hyperstimulation.

Treatment groups

590 Participants
are divided into 2 treatment groups
Group A: Recombinant LH Supplementation GroupExperimental treatment 3 interventions
Group B: Conventional rFSH-Only GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of cycles with no usable embryos

The number of IVF/ICSI cycles with no transferable embryos divided by the total number of oocyte retrieval cycles, evaluated based on embryo morphology and grading on Day 3 or Day 5-6 after fertilization.

Time frame
7 days after oocyte retrieval

Secondary outcomes

1

Number of high-quality Day 3 embryos

Count of embryos meeting morphological criteria for high quality on Day 3 after fertilization, as determined by standard embryology scoring.

Time frame
7 days after oocyte retrieval
2

Total gonadotropin dose used

Cumulative dose (IU) of gonadotropins administered from stimulation start to trigger day.

Time frame
At the end of ovarian stimulation (average 8-12 days)
3

Duration of gonadotropin stimulation

Number of days from gonadotropin initiation to trigger day.

Time frame
At the end of ovarian stimulation (average 8-12 days)
4

Number of oocytes retrieved

Total number of oocytes collected during transvaginal ultrasound-guided oocyte retrieval.

Time frame
At oocyte retrieval (36-38 hours after trigger)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing University

Lead sponsor

Source ClinicalTrials.gov
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