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
Qualifiers
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
Treatments tested in this trial
- Recombinant Human Follitropin Alfa Solution for Injection (Gonal-f®)
- Recombinant Human Lutropin alfa for Injection (r-hLH, Luveris®)
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov