Infertility (IVF Patients)FSH-PPOSNCT07772375
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
A study testing Follitropin Alfa (Follitrope) in people with Infertility (IVF Patients) and Infertility Assisted Reproductive Technology, run by Vietnam Military Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Infertility (IVF Patients), Infertility Assisted Reproductive Technology
- What is being tested?
- Follitropin Alfa (Follitrope)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Sep 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
An Sinh Hospital
Ho Chi Minh City, Ho Chi Minh City, 722210
Truc Nhu Thanh Vo, PhD Student, +84 0764681310, vonhuthanhtruc.art@gmail.com
trucvnt@ansinh.com.vn
About this study
Official title: A Randomized Controlled Trial Comparing 225 IU Versus 300 IU Starting Doses of Follicle-Stimulating Hormone in Progestin-Primed Ovarian Stimulation for Women With Good Prognosis
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.
Read the 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.
- Being tested
- Follitropin Alfa (Follitrope)
- Keywords
- Progestin-primed ovarian stimulation, PPOS, FSH dose, Embryo quality, blastulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Follitropin Alfa (Follitrope) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICSI to Day 6 of embryo culture
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 12 weeks after frozen embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start15 Sep 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vietnam Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vo Nhu Thanh Truc, Vietnam Military Medical University
- Investigators
- Truc Nhu Thanh Vo, PhD Student, Principal investigator, Vietnam Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772375
- Sponsor's protocol ID
- FSH-PPOS-225-300
- Acronym
- FSH-PPOS
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers due to participant privacy and data confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing 225 IU Versus 300 IU Starting Doses of Follicle-Stimulating Hormone in Progestin-Primed Ovarian Stimulation for Women With Good Prognosis
- ClinicalTrials.gov ID
- NCT07772375
- Acronym / sponsor ID
- FSH-PPOS / FSH-PPOS-225-300
- Keywords
- Progestin-primed ovarian stimulation, PPOS, FSH dose, Embryo quality, blastulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Vietnam Military Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSH 225 IU | Experimental | Drug: Follitropin Alfa (Follitrope)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). |
| FSH 300 IU | Experimental | Drug: Follitropin Alfa (Follitrope)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). |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female patient or oocyte donor aged <35 years.
- Body mass index (BMI) between 18 and 25 kg/m².
- Normal ovarian reserve, defined by:
- First IVF treatment cycle.
- Controlled ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol with recombinant FSH and dydrogesterone.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follitropin 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. | Drug | FSH 225 IU, FSH 300 IU |
Primary outcome
Blastulation rate
Time frame: 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.
9 secondary outcomes
Oocyte morphology abnormality rate
Time frame: At the time of oocyte denudation, prior to ICSI
Fertilization rate
Time frame: Approximately 16-18 hours after ICSI
Cleavage embryo formation rate
Time frame: Approximately 68-72 hours after ICSI
Good-quality cleavage-stage embryo rate
Time frame: Approximately 68-72 hours after ICSI
Good-quality blastocyst rate
Time frame: From Day 5 to Day 6 after ICSI
Usable blastocyst rate
Time frame: From Day 5 to Day 6 after ICSI
Biochemical pregnancy rate
Time frame: Approximately 14 days after frozen embryo transfer
Clinical pregnancy rate
Time frame: Approximately 5-7 weeks after frozen embryo transfer
Ongoing pregnancy rate
Time frame: Approximately 12 weeks after frozen embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers due to participant privacy and data confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Truc Nhu Thanh Vo, PhD Student principal investigator
Vietnam Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follitropin Alfa (Follitrope) in people with Infertility (IVF Patients) and Infertility Assisted Reproductive Technology, run by Vietnam Military Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Truc Nhu Thanh Vo, PhD Student (+84 0764681310, vonhuthanhtruc.art@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastulation rate (time frame: From ICSI to Day 6 of embryo culture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.