Infertility Assisted Reproductive Technology, Infertility (IVF Patients)
Conditions
Keywords
Progestin-primed ovarian stimulation, PPOS, FSH dose, Embryo quality, blastulation
Brief summary
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.
Detailed description
This study is designed to evaluate whether the starting dose of follicle-stimulating hormone (FSH) affects oocyte and embryo outcomes in women with a good prognosis undergoing in vitro fertilization (IVF) using a progestin-primed ovarian stimulation (PPOS) protocol. The optimal gonadotropin dose for women with a good prognosis remains uncertain. Although higher FSH doses may increase ovarian stimulation intensity, greater gonadotropin exposure may not necessarily improve oocyte or embryo outcomes. Conversely, a lower starting dose may provide adequate ovarian stimulation while reducing medication exposure. Therefore, this study will compare two starting FSH doses, 225 IU and 300 IU, in women with a good reproductive prognosis. Eligible participants will be randomly assigned to receive either 225 IU or 300 IU of FSH as the starting dose during PPOS. The study will assess whether the starting FSH dose is associated with differences in oocyte characteristics, fertilization, embryo development, and blastocyst formation. The primary outcome is blastocyst formation rate. Secondary outcomes will include oocyte morphology, fertilization rate, cleavage-stage embryo development and quality, and blastocyst quality and usability. Participants will also be followed through the first frozen embryo transfer cycle using embryos generated during the study cycle. Outcomes of the first frozen embryo transfer cycle will be assessed as prespecified secondary outcomes. The results of this study may provide evidence to guide the selection of an appropriate starting FSH dose for women with a good prognosis undergoing IVF with PPOS.
Interventions
DRUGFollitropin Alfa (Follitrope)
Follicle-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.
Sponsors
Vietnam Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
No
Inclusion criteria
* Female patient or oocyte donor aged \<35 years. * Body mass index (BMI) between 18 and 25 kg/m². * Normal ovarian reserve, defined by: * Antral follicle count (AFC) ≥8 on ultrasound; and * AMH level between 1.5 and 4.5 ng/mL. * First IVF treatment cycle. * Controlled ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol with recombinant FSH and dydrogesterone. * Indication for in vitro fertilization using intracytoplasmic sperm injection (ICSI). * Indication for extended embryo culture to the blastocyst stage. * Willingness to participate in the study and provision of written informed consent.
Exclusion criteria
* 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. * Indication for luteinizing hormone (LH) supplementation during controlled ovarian stimulation. * Poor sperm quality, cryptozoospermia, surgically retrieved sperm (PESA, TESE, or microTESE), cryopreserved sperm, or donor sperm. * Indication for artificial oocyte activation (AOA) or rescue ICSI (R-ICSI).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blastulation rate | From ICSI to Day 6 of embryo culture | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oocyte morphology abnormality rate | At the time of oocyte denudation, prior to ICSI | 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. |
| Fertilization rate | Approximately 16-18 hours after ICSI | 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. |
| Cleavage embryo formation rate | Approximately 68-72 hours after ICSI | 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. |
| Good-quality cleavage-stage embryo rate | Approximately 68-72 hours after ICSI | 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. |
| Good-quality blastocyst rate | From Day 5 to Day 6 after ICSI | The proportion of MII oocytes subjected to ICSI that result in good-quality blastocysts, according to the morphological criteria prespecified in the study protocol, calculated as the number of good-quality blastocysts divided by the total number of MII oocytes subjected to ICSI, multiplied by 100. |
| Usable blastocyst rate | From Day 5 to Day 6 after ICSI | The proportion of MII oocytes subjected to ICSI that result in usable blastocysts, according to the criteria prespecified in the study protocol, calculated as the number of usable blastocysts divided by the total number of MII oocytes subjected to ICSI, multiplied by 100. |
| Biochemical pregnancy rate | Approximately 14 days after frozen embryo transfer | The proportion of first frozen embryo transfer cycles with a positive serum beta-human chorionic gonadotropin (β-hCG) test, defined according to the prespecified threshold in the study protocol, among all first frozen embryo transfer cycles. |
| Clinical pregnancy rate | Approximately 5-7 weeks after frozen embryo transfer | The proportion of first frozen embryo transfer cycles resulting in a clinical pregnancy, defined by the presence of at least one gestational sac on ultrasound, calculated as the number of clinical pregnancies divided by the number of first frozen embryo transfer cycles, multiplied by 100. |
| Ongoing pregnancy rate | Approximately 12 weeks after frozen embryo transfer | The proportion of first frozen embryo transfer cycles resulting in an ongoing pregnancy, according to the definition prespecified in the study protocol, calculated as the number of ongoing pregnancies divided by the number of first frozen embryo transfer cycles, multiplied by 100. |
Countries
Vietnam
Contacts
CONTACTTruc Nhu Thanh Vo, PhD Student
PRINCIPAL_INVESTIGATORTruc Nhu Thanh Vo, PhD Student
Vietnam Military Medical University
Outcome results
None listed