225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-34
SponsorVietnam Military Medical University
About this trial
This randomized controlled trial will compare two starting doses of follicle-stimulating hormone (FSH), 225 IU and 300 IU, during progestin-primed ovarian stimulation (PPOS) in women undergoing in vitro fertilization (IVF) who have a good reproductive prognosis. Participants will be randomly assigned to receive either 225 IU or 300 IU of FSH at the start of ovarian stimulation. The study will evaluate whether the starting FSH dose affects oocyte and embryo outcomes, with blastocyst formation as the primary outcome. Other outcomes will include oocyte morphology, fertilization, embryo development, and embryo quality. The findings may help determine an appropriate starting FSH dose for women with a good prognosis undergoing IVF using the PPOS protocol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patient or oocyte donor aged <35 years.
Body mass index (BMI) between 18 and 25 kg/m².
Antral follicle count (AFC) ≥8 on ultrasound; and
AMH level between 1.5 and 4.5 ng/mL.
Disqualifiers
Polycystic ovary syndrome (PCOS) diagnosed according to the Rotterdam criteria, currently referred to as polyendocrine metabolic ovarian syndrome (PMOS).
Structural abnormalities of the ovaries.
Ovarian endometriosis.
Medical or gynecological conditions that may affect ovarian response to controlled ovarian stimulation.
Trial design
Design model
Parallel
Treatments tested in this trial
Follitropin Alfa (Follitrope)
DrugFollicle-stimulating hormone (FSH) is administered by subcutaneous injection as the gonadotropin for ovarian stimulation in a progestin-primed ovarian stimulation (PPOS) protocol. Participants are randomized to receive either 225 IU or 300 IU of FSH daily according to their assigned study arm, and the assigned dose is maintained unchanged throughout the ovarian stimulation period.
Treatment groups
380 Participants
are divided into 2 treatment groupsGroup A: FSH 225 IUExperimental treatment 1 intervention
Group B: FSH 300 IUExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Blastulation rate
The proportion of blastocysts formed among all mature (MII) oocytes subjected to intracytoplasmic sperm injection (ICSI), calculated as the total number of blastocysts divided by the total number of MII oocytes subjected to ICSI, multiplied by 100.
Time frame
From ICSI to Day 6 of embryo cultureSecondary outcomes
1
Oocyte morphology abnormality rate
The proportion of retrieved oocytes that exhibit one or more morphological abnormalities, calculated as the number of retrieved oocytes with morphological abnormalities divided by the total number of oocytes retrieved, multiplied by 100.
Time frame
At the time of oocyte denudation, prior to ICSI2
Fertilization rate
The proportion of mature (MII) oocytes subjected to ICSI that are normally fertilized, defined by the presence of two pronuclei (2PN), calculated as the number of normally fertilized oocytes divided by the total number of MII oocytes subjected to ICSI, multiplied by 100.
Time frame
Approximately 16-18 hours after ICSI3
Cleavage embryo formation rate
The proportion of MII oocytes subjected to ICSI that develop into cleavage-stage embryos, calculated as the number of cleavage-stage embryos divided by the total number of MII oocytes subjected to ICSI, multiplied by 100.
Time frame
Approximately 68-72 hours after ICSI4
Good-quality cleavage-stage embryo rate
The proportion of MII oocytes subjected to ICSI that result in good-quality cleavage-stage embryos, according to the morphological criteria prespecified in the study protocol, calculated as the number of good-quality cleavage-stage embryos divided by the total number of MII oocytes subjected to ICSI, multiplied by 100.
Time frame
Approximately 68-72 hours after ICSISponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: