Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment
ConditionInfertility
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age35-40
SponsorNanjing University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 35 to 40 (including 40)
18.5<BMI<28 kg/m2
AFC up to 14
First or second ART cycle
Disqualifiers
Contraindications to ART treatment
History of two or more spontaneous miscarriages
History of two or more implantation failures after fresh or frozen-warmed embryo transfers
Diagnosis of severe endometriosis
Trial design
Design model
Parallel
Treatments tested in this trial
Recombinant Human Follitropin Alfa Solution for Injection (Gonal-f®)
DrugAs a r-hFSH agent, Gonal-f® is used for COS. It is a prefilled ready to use pen device containing follitropin alfa for injection and is designed for subcutaneous self-administration by patients undergoing COS for ART. It is available as dose presentations of 150 IU and 450 IU. The investigators and/or his/her delegate/s will explain the use of Gonal-f® prefilled pen. Gonal-f® will be prescribed by the investigator based on clinical diagnosis and treatment routines, and will not be provided free of charge.
Recombinant Human Lutropin alfa for Injection (r-hLH, Luveris®)
DrugThis product is a white freeze-dried powder and a colorless and clear injection solvent, and stored away from light under 25℃ in the original packaging. Luveris® will be provided free of charge.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Treatment groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 3 after fertilizationSecondary outcomes
1
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.
Time frame
24 hours after Oocytes pick up2
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
Time frame
24 hours after Oocytes pick up3
Total r-hFSH dose
Total r-hFSH dose is defined as the total dose of r-hFSH used for subcutaneous injection during COS period.
Time frame
24 hours after ovulation triggering4
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.
Time frame
24 hours after fertilizationSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: