Polycystic Ovary Syndrome (PCOS)PPOS-PCOS-IVFNCT07394530
Comparison of IVF Outcomes Between PPOS and Antagonist Protocols in Women With PCOS
A study testing Progestin-Primed Ovarian Stimulation (PPOS) and GnRH Antagonist Protocol in people with Polycystic Ovary Syndrome (PCOS) and Female Infertility, run by Hanoi General Hospital (Vietnam) at 1 site in Vietnam.
Trial summary
This study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Female Infertility
- What is being tested?
- Progestin-Primed Ovarian Stimulation (PPOS) and GnRH Antagonist Protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Jan 2026to 30 Jun 2028
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-40 years
- Diagnosed with polycystic ovary syndrome (PCOS) according to the modified Rotterdam criteria (2004) (≥2 of 3: oligo/anovulation, hyperandrogenism, or polycystic ovarian morphology on ultrasound)
- Indicated for in vitro fertilization (IVF) due to PCOS alone or PCOS with other infertility factors (e.g., tubal factor, previous failed IUI)
- Eligible for controlled ovarian stimulation for IVF
- Husband/partner with normal sperm parameters or mild to moderate oligoasthenoteratozoospermia (OAT)
- Willing and able to provide written informed consent and comply with study procedures.
Who cannot join
- Uterine abnormalities that may impair implantation or pregnancy outcomes, including congenital uterine malformations, large fibroids distorting the uterine cavity, adenomyosis, or severe intrauterine pathology.
- History of major ovarian or uterine surgery affecting ovarian reserve or uterine structure (e.g., ovarian cystectomy, endometriosis surgery, myomectomy, unilateral oophorectomy)
- History of recurrent pregnancy loss (≥3 spontaneous miscarriages)
- Known chromosomal abnormalities in either partner
- Inability to adhere to study protocol or follow-up procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anh Huynh Phuong Nguyen, MD, MSc, Study Coordinator contact
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi General Hospital
Hanoi, Hanoi, 10000
Phuong Duy Nguyen, MD, MS, +84 986656835, nguyenduyphuongncs44@gmail.com
About this study
Official title: A Comparative Study of In Vitro Fertilization Outcomes Between PPOS and Antagonist Protocols in Women With Polycystic Ovary Syndrome
This study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol.
- Being tested
- Progestin-Primed Ovarian Stimulation (PPOS), GnRH Antagonist Protocol
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progestin-Primed Ovarian Stimulation (PPOS)Drug
Ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol, including gonadotropins combined with oral progestin for pituitary suppression during in vitro fertilization treatment.
GnRH Antagonist ProtocolDrug
Ovarian stimulation using a gonadotropin-releasing hormone (GnRH) antagonist protocol for pituitary suppression during in vitro fertilization treatment.
| Study group | Role | What they receive |
|---|---|---|
| PPOS Protocol | Experimental | Participants receive ovarian stimulation using the progestin-primed ovarian stimulation (PPOS) protocol for in vitro fertilization. Receives: Drug: Progestin-Primed Ovarian Stimulation (PPOS) |
| GnRH Antagonist Protocol | Active comparator | Participants receive ovarian stimulation using a GnRH antagonist protocol for in vitro fertilization. Receives: Drug: GnRH Antagonist Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate at 12 weeks
Ongoing pregnancy defined as a viable intrauterine pregnancy with fetal cardiac activity confirmed by ultrasound at or beyond 12 weeks of gestation.
Measured: Up to 12 weeks after embryo transfer
Secondary outcomes (6)
Number of Oocytes Retrieved
Total number of oocytes retrieved per ovarian stimulation cycle at the time of oocyte retrieval
Measured: From ovarian stimulation start to oocyte retrieval (approximately 10-14 days)
Number of Mature (MII) Oocytes
Number of mature oocytes at the metaphase II (MII) stage identified at the time of oocyte retrieval
Measured: At the time of oocyte retrieval (approximately 10-14 days after stimulation start)
Live birth rate
Live birth rate of live-born infants at ≥24 weeks of gestation or with birth weight ≥500 g and signs of life after birth.
Measured: Up to delivery (approximately 9-12 months after embryo transfer)
Clinical pregnancy rate
Clinical pregnancy defined as the presence of a gestational sac with fetal cardiac activity confirmed by ultrasound
Measured: 6-7 weeks after embryo transfer
Fertilization Rate
Fertilization rate, defined as the percentage of fertilized oocytes
Measured: 16-18 hours after oocyte insemination
Number of Usable Embryos
Measured: From fertilization to embryo assessment (approximately Day 3 to Day 5 after oocyte retrieval).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start20 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi General Hospital (Vietnam)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Duy Phuong, Hanoi Medical University
- Investigators
- Phuong Duy Nguyen, MD, MS, Principal investigator, Hanoi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394530
- Sponsor's protocol ID
- HGH-IVF-PCOS-PPOS-ANT-2026
- Other IDs
- HMUIRB2402, 05/CN-BVĐKHN
- Acronym
- PPOS-PCOS-IVF
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of In Vitro Fertilization Outcomes Between PPOS and Antagonist Protocols in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07394530
- Acronym / sponsor ID
- PPOS-PCOS-IVF / HGH-IVF-PCOS-PPOS-ANT-2026
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hanoi General Hospital (Vietnam)University, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Feb 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 study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPOS Protocol | Experimental | Drug: Progestin-Primed Ovarian Stimulation (PPOS)Participants receive ovarian stimulation using the progestin-primed ovarian stimulation (PPOS) protocol for in vitro fertilization. |
| GnRH Antagonist Protocol | Active comparator | Drug: GnRH Antagonist ProtocolParticipants receive ovarian stimulation using a GnRH antagonist protocol for in vitro fertilization. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18-40 years
- Diagnosed with polycystic ovary syndrome (PCOS) according to the modified Rotterdam criteria (2004) (≥2 of 3: oligo/anovulation, hyperandrogenism, or polycystic ovarian morphology on ultrasound)
- Indicated for in vitro fertilization (IVF) due to PCOS alone or PCOS with other infertility factors (e.g., tubal factor, previous failed IUI)
- Eligible for controlled ovarian stimulation for IVF
- Husband/partner with normal sperm parameters or mild to moderate oligoasthenoteratozoospermia (OAT)
Key exclusion criteria (5 listed)
- Uterine abnormalities that may impair implantation or pregnancy outcomes, including congenital uterine malformations, large fibroids distorting the uterine cavity, adenomyosis, or severe intrauterine pathology.
- History of major ovarian or uterine surgery affecting ovarian reserve or uterine structure (e.g., ovarian cystectomy, endometriosis surgery, myomectomy, unilateral oophorectomy)
- History of recurrent pregnancy loss (≥3 spontaneous miscarriages)
- Known chromosomal abnormalities in either partner
- Inability to adhere to study protocol or follow-up procedures
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 |
|---|---|---|
| Progestin-Primed Ovarian Stimulation (PPOS)Ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol, including gonadotropins combined with oral progestin for pituitary suppression during in vitro fertilization treatment. | Drug | PPOS Protocol |
| GnRH Antagonist ProtocolOvarian stimulation using a gonadotropin-releasing hormone (GnRH) antagonist protocol for pituitary suppression during in vitro fertilization treatment. | Drug | GnRH Antagonist Protocol |
Primary outcome
Ongoing pregnancy rate at 12 weeks
Time frame: Up to 12 weeks after embryo transfer
Ongoing pregnancy defined as a viable intrauterine pregnancy with fetal cardiac activity confirmed by ultrasound at or beyond 12 weeks of gestation.
6 secondary outcomes
Number of Oocytes Retrieved
Time frame: From ovarian stimulation start to oocyte retrieval (approximately 10-14 days)
Number of Mature (MII) Oocytes
Time frame: At the time of oocyte retrieval (approximately 10-14 days after stimulation start)
Live birth rate
Time frame: Up to delivery (approximately 9-12 months after embryo transfer)
Clinical pregnancy rate
Time frame: 6-7 weeks after embryo transfer
Fertilization Rate
Time frame: 16-18 hours after oocyte insemination
Number of Usable Embryos
Time frame: From fertilization to embryo assessment (approximately Day 3 to Day 5 after oocyte retrieval).
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 5 Aug 2026.
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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.
Anh Huynh Phuong Nguyen, MD, MSc, Study Coordinator contact
Phuong Duy Nguyen, MD, MS principal investigator
Hanoi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progestin-Primed Ovarian Stimulation (PPOS) and GnRH Antagonist Protocol in people with Polycystic Ovary Syndrome (PCOS) and Female Infertility, run by Hanoi General Hospital (Vietnam) 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 6 inclusion and 5 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 5 Aug 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 Phuong Duy Nguyen, MD, MSc - PI (+84 986656835, nguyenduyphuongncs44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate at 12 weeks (time frame: Up to 12 weeks after embryo transfer). 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 5 Aug 2026.