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

NCT07772375 | Not Yet Recruiting

• 1 other identifier: FSH-PPOS-225-300
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility (IVF Patients); Infertility Assisted Reproductive Technology

Keywords

Progestin-primed ovarian stimulation; PPOS; FSH dose; Embryo quality; blastulation

Outcome Measures

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.

  From ICSI to Day 6 of embryo culture

Secondary Outcomes (9)

• Oocyte morphology abnormality rate

  At the time of oocyte denudation, prior to ICSI

• Fertilization rate

  Approximately 16-18 hours after ICSI

• Cleavage embryo formation rate

  Approximately 68-72 hours after ICSI

• Good-quality cleavage-stage embryo rate

  Approximately 68-72 hours after ICSI

• Good-quality blastocyst rate

  From Day 5 to Day 6 after ICSI

Study Arms (2)

FSH 225 IU

EXPERIMENTAL

Participants assigned to this arm will receive a starting dose of 225 IU follicle-stimulating hormone (FSH) during progestin-primed ovarian stimulation (PPOS) for in vitro fertilization (IVF).

Drug: Follitropin Alfa (Follitrope)

FSH 300 IU

EXPERIMENTAL

Participants assigned to this arm will receive a starting dose of 300 IU follicle-stimulating hormone (FSH) during progestin-primed ovarian stimulation (PPOS) for in vitro fertilization (IVF).

Drug: Follitropin Alfa (Follitrope)

Interventions

Follitropin Alfa (Follitrope) DRUG

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.

FSH 225 IU; FSH 300 IU

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vietnam Military Medical University: lead

Study Sites (1)

An Sinh Hospital

Ho Chi Minh City, Ho Chi Minh City, 722210, Vietnam

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Truc Nhu Thanh Vo, PhD Student

  Vietnam Military Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Truc Nhu Thanh Vo, PhD Student

CONTACT

+84 0764681310; vonhuthanhtruc.art@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of IVF laboratory

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 19, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)