Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07128394

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Excessive suppression of luteinizing hormone (LH) during ovarian stimulation with a long gonadotropin-releasing hormone agonist (GnRH-a) protocol has been associated with suboptimal follicular development, impaired oocyte maturation, and reduced embryo quality. LH plays a critical role in the final stages of folliculogenesis, steroidogenesis, and ovulation, and its deficiency during controlled ovarian hyperstimulation may adversely affect the developmental competence of oocytes.

This randomized controlled trial is designed to evaluate whether supplementation with exogenous LH can improve embryo quality in patients undergoing in vitro fertilization (IVF) with excessive LH suppression during a long GnRH-a protocol. Eligible participants are women meeting predefined hormonal suppression criteria prior to or during stimulation. Participants will be randomly assigned to receive either exogenous LH supplementation in addition to standard ovarian stimulation or standard care without LH supplementation.

The primary endpoint is the proportion of high-quality embryos obtained per cycle. Secondary endpoints include clinical pregnancy rate, implantation rate, live birth rate, and safety outcomes such as incidence of ovarian hyperstimulation syndrome (OHSS) and adverse events.

The study aims to provide high-quality evidence to guide the optimal management of patients with profound LH suppression during controlled ovarian stimulation. Findings from this trial may contribute to refining stimulation protocols and improving reproductive outcomes in assisted reproductive technology (ART).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: lutropin alfa, Luveris

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.

Other names: follitropin alfa, Gonal-F

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.

Other names: triptorelin, Diphereline

Primary outcomes

  1. Proportion of cycles with no usable embryos

    Time frame: 7 days after oocyte retrieval

    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.

Secondary outcomes

  1. Number of high-quality Day 3 embryos

    Time frame: 7 days after oocyte retrieval

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

  2. Total gonadotropin dose used

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

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

  3. Duration of gonadotropin stimulation

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

    Number of days from gonadotropin initiation to trigger day.

  4. Number of oocytes retrieved

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

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

  5. Clinical pregnancy rate

    Time frame: 30 days after embryo transfer

    Proportion of embryo transfer cycles resulting in at least one intrauterine gestational sac with fetal heartbeat, confirmed by transvaginal ultrasound.

  6. Early miscarriage rate

    Time frame: Within 12 weeks of gestation

    Proportion of clinical pregnancies ending in miscarriage before 12 completed weeks of gestation.

  7. Live birth rate

    Time frame: At delivery (up to 1 year after embryo transfer)

    Proportion of embryo transfer cycles resulting in the delivery of at least one live-born infant.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Zhang, PhD

CONTACT

[email protected]

+8618262637731

Yue Jiang, PhD

CONTACT

[email protected]

+8613814122872

Sponsors and collaborators

Lead sponsor

Nanjing University

Other

Registry information

Official study title

Exogenous Luteinizing Hormone Supplementation to Improve Embryo Quality in Patients With Excessive LH Suppression During a Long GnRH-Agonist Protocol: A Randomized Controlled Trial

Acronym: ELH-IVF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.