Status
Recruiting
Phase
Not applicable
Enrollment
590
Locations
1
Results
Not posted
Publications
10
Study summary
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.
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).
Interventions
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.
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.
DRUG
Long-acting GnRH agonist (3.75 mg) administered subcutaneously on menstrual cycle day 2-4 for pituitary downregulation before controlled ovarian hyperstimulation.
Timeline
First posted
Aug 19, 2025
Study start
Feb 1, 2024
Primary completion
Sep 30, 2026
Study completion
Nov 30, 2026
Results posted
Not reported
Registry updated
Aug 19, 2025
Outcomes
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.
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.
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.
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.
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.
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.
Early miscarriage rate
Time frame · Within 12 weeks of gestation
Proportion of clinical pregnancies ending in miscarriage before 12 completed weeks of gestation.
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.
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Nanjing Drum Tower Hospital, Nanjing University Medical School
Nanjing, Jiangsu, China
Publications
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