Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment
NCT Number: NCT06571214
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Infertility
Interventions: DRUG: Recombinant Human Follitropin Alfa Solution for Injection (Gonal-f®)|DRUG: Recombinant Human Lutropin alfa for Injection (r-hLH, Luveris®)
Sponsor: Nanjing University
Sex: FEMALE
Age: ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-01-30
Locations: Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China

Summary:
This will be an exploratory, prospective, randomized, open-label and controlled trial to evaluate the potential benefit of r-hFSH:r-hLH 2:1 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment.

After signing informed consent form (ICF), all eligible participants will be randomly assigned in a 1:1 ratio to either treatment or control group, and GnRH antagonist protocol will be used in both treatment and control groups.

Primary Outcome Measures: Good quality embryo rate (cleavage stage), Cleavage stage good-quality embryos are defined as embryos derived from normally fertilized zygotes with 7\~9 cells on day 3 post-fertilization, stage-specific cell size, less than 10% fragmentation, and no multinucleation. Cleavage stage good-quality embryo rate is defined as the number of cleavage stage good-quality embryos divided by the number of normally fertilized zygotes. Embryos will be assessed by two independent experienced embryologists to minimize intra-observation variability., Day 3 after fertilization
Secondary Outcome Measures: Number of oocytes, Number of oocytes is defined as the total number of oocytes obtained through transvaginal ultrasound guided puncture on the day of OPU. All follicles with an estimated diameter of ≥12 mm should be punctured., 24 hours after Oocytes pick up|Number of MII oocytes (analyzed in ICSI subgroup only), Number of MII oocyte is defined as the total number of an oocyte at metaphase of meiosis II, exhibiting the first polar body and with the ability to become fertilized, 24 hours after Oocytes pick up|Total r-hFSH dose, Total r-hFSH dose is defined as the total dose of r-hFSH used for subcutaneous injection during COS period., 24 hours after ovulation triggering|Fertilization rate, * IVF normal fertilization rate is defined as the number of oocytes with 2PN and 2PB divided by the number of COCs inseminated.
* ICSI normal fertilization rate is defined as the number of oocytes with 2PN and 2PB divided by the number of MII oocytes injected., 24 hours after fertilization|Blastocyst development rate, Blastocyst development rate is defined as the proportion of blastocysts observed at 116 ± 2 h post-insemination as a function of the number of normally fertilized oocytes., 5 days after fertilization, up to 7 days|Utilizable embryo rate, Utilizable embryo rate is defined as the number of embryos (or blastocysts) suitable for transfer or cryopreservation as a function of the number of normally fertilized (2PN) oocytes observed on Day 1., 5 days after fertilization, up to 7 days|Implantation rate, Implantation rate is defined as the number of gestational sacs observed divided by the number of embryos transferred using transvaginal ultrasound 4\~6 weeks after embryo transfer., At 4-6 weeks of amenorrhea after customized timing of embryo transfer|Clinical pregnancy rate (per transfer cycle and per oocyte retrieval cycle), Clinical pregnancy rate is defined as the number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, or embryo transfer cycles. Clinical pregnancy is defined as the presence of gestational sac (intrauterine or ectopic) using ultrasound examination at 4\~6 weeks after embryo transfer., At 4-6 weeks of amenorrhea after customized timing of embryo transfer|Ongoing pregnancy rate, Ongoing pregnancy rate is defined as the number of intrauterine pregnancies continued for 12 gestational weeks divided by the number of embryo transfer cycles., At 12 weeks of amenorrhea after customized timing of embryo transfer|Ovarian sensitivity index (OSI), OSI is defined as the total r-hFSH dose divided by the number of oocytes retrieved., 24 hours after fertilization|Follicular output rate (FORT), FORT is defined as the number of pre-ovulatory follicles (16\~22 mm) on the day of trigger divided by the AFC (3\~8 mm), 24 hours after fertilization|Follicle oocyte index (FOI), FOI is defined as the number of total oocytes retrieved divided by the AFC, 24 hours after fertilization|Safety Assessments, AE, SAE and OHSS, During the COS cycle (average cycle range 11 days), Up to 12 weeks after transfer