225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women

N/ANot Yet RecruitingNCT07772375

Vietnam Military Medical University380 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 34 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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 culture

Secondary Outcomes

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 ICSI

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 ICSI

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 ICSI

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 ICSI

Good-quality blastocyst rate

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.

Time frame: From Day 5 to Day 6 after ICSI

Usable blastocyst rate

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.

Time frame: From Day 5 to Day 6 after ICSI

Biochemical pregnancy rate

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.

Time frame: Approximately 14 days after frozen embryo transfer

Clinical pregnancy rate

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.

Time frame: Approximately 5-7 weeks after frozen embryo transfer

Ongoing pregnancy rate

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.

Time frame: Approximately 12 weeks after frozen embryo transfer

225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts