Polycystic Ovary Syndrome (PCOS)SAIGON-PTCNCT07171970
IVM - Fresh ET (THE SAIGON PROTOCOL) Versus IVF - FET in PCOS Women
A study testing IVM-Fresh (No gonadotropin + Fresh embryo transfer) and IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer) in people with Polycystic Ovary Syndrome (PCOS) and In Vitro Maturation of Oocytes, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
Assisted Reproductive Technologies (ART) aim to increase success rates while minimizing patient risks. For women with high AFC or PCOS, conventional IVF carries a high risk of OHSS (Ho et al., 2019). Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), In Vitro Maturation of Oocytes, Fresh Embryo Transfer
- What is being tested?
- IVM-Fresh (No gonadotropin + Fresh embryo transfer) and IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteVietnam
- Study dates
- 22 Sep 2025to 15 Jan 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 - 42 years old.
- Diagnosed with PCOS, followed Rotterdam 2003 criteria (Group TREP consensus workshop, 2004)
- Had fewer than three previous failed frozen embryo transfer (FET) cycles
- Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts.
- Agreeing to participate in the study
Who cannot join
- Having allergy and contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease)
- Cycles with preimplantation genetic testing indication
- Oocyte donation cycles
- Having untreated uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus, large leiomyoma ≥5 cm in diameter; adenomyosis, endometrial polyp, hydrosalpinx).
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
IVFMD - My Duc Hospital
Ho Chi Minh City
Tuong M Ho, MD, +84 90 3633377, tuongho.ivfmd@gmail.com
About this study
Official title: The Effectiveness and Safety of In Vitro Maturation With Fresh Embryo Transfer (The SAIGON Protocol) Versus In Vitro Fertilization With Frozen Embryo Transfer in Women With Polycystic Ovary Syndrome
Assisted Reproductive Technologies (ART) aim to increase success rates while minimizing patient risks. For women with high AFC or PCOS, conventional IVF carries a high risk of OHSS (Ho et al., 2019). A modern IVF strategy to prevent this uses a GnRH agonist trigger, requiring a "freeze-all" and subsequent FET (Wong et al., 2017). This reduces OHSS risk but can increase time to pregnancy (Vuong et al., 2021) and treatment burden.
IVM is a patient-friendly alternative that eliminates OHSS risk by avoiding high-dose gonadotropins. A 2020 trial by Vuong et al. compared CAPA-IVM-FET to conventional IVF-FET in women with high AFC. IVM yielded a comparable live birth rate (35.2%) versus IVF (43.2%), with a 0% OHSS rate in IVM compared to 0.7% in IVF (Vuong et al., 2020).
Read more
The optimal transfer method (fresh or frozen) in IVM cycles is debated. A 2021 pilot RCT by Vuong et al. found a freeze-only strategy after CAPA-IVM led to a significantly higher live birth rate (60%) than a fresh transfer (20%) (Vuong et al., 2021), but increased time to pregnancy (194 vs. 150 days) (Vuong et al., 2021). A refined CAPA-IVM protocol, which uses no gonadotropins, allowed for fresh embryo transfer in the same cycle, resulting in a numerically higher ongoing pregnancy rate (43.3% vs. 33.3%) than FET (Vuong et al., 2025).
This raises an important question: how does a simplified IVM strategy with fresh transfer compare to the established "safety-net" IVF strategy with FET? These two approaches represent opposing clinical philosophies. No large-scale study has yet compared them in women with PCOS. Therefore, this study is designed to compare the SAIGON protocol (gonadotropin-free CAPA-IVM with fresh ET) against a standard GnRH-antagonist IVF protocol with agonist trigger and subsequent FET.
Read the detailed description
- Screening for eligibility and randomization: Women who are potentially eligible are provided with information about the trial. Screening is done on the day of the first visit, and patients are given informed consent form to sign before enrollment. Participants are then randomly assigned (1:1) to either the CAPA-IVM or IVF-FET group.
- After randomisation 2.1. IVM-FRESH (The SAIGON Protocol):
- Treatment begins on day 2-4 of the menstrual cycle.
- Endometrial preparation uses oral estradiol valerate (Progynova®; Delpharm Lille SAS, France) 8mg/day for at least 10 days.
- Immature oocyte retrieval is performed when the endometrial thickness is ≥ 8 mm.
- Mature oocytes are fertilized via ICSI.
- Luteal phase support is provided with vaginal progesterone (800 mg/day) + dydrogesterone (20mg/day) starting on the day of ICSI.
- A fresh embryo transfer is performed three or five days after progesterone administration, depending on the embryo stage. 2.2. IVF-FET (Frozen Transfer Protocol):
- This protocol uses a random start approach, beginning on the day of the patient's first visit.
- Ovarian stimulation is done using a GnRH antagonist protocol with a starting dose of 150 IU/day of rFSH.
- A GnRH agonist trigger is administered when at least two leading follicles reach ≥ 17 mm in diameter.
- Insemination is performed using ICSI for matured oocytes.
- The endometrium is prepared for frozen embryo transfer using oral oestradiol valerate (8mg/day) and vaginal progesterone (800 mg/day) + dydrogesterone (20mg/day) when endometrial thickness is ≥ 8 mm.
- Surviving embryos are thawed and transferred two hours after thawing under ultrasound guidance.
- Pregnancy and outcomes:
- A pregnancy test is performed 10-14 days after embryo transfer. A positive result is a serum hCG level of ≥ 25 mIU/mL.
- Both groups continue hormone supplementation if the pregnancy test is positive.
- The primary outcome of the study is the live birth rate after one embryo transfer. Secondary outcomes include cumulative ongoing pregnancy, time to ongoing pregnancy, clinical pregnancy rate, miscarriage, and other treatment and pregnancy complications.
- Obstetric and neonatal outcomes: All data relating to the delivery process and neonatal care will be recorded by the data management system of IVFMD.
- Being tested
- IVM-Fresh (No gonadotropin + Fresh embryo transfer), IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)
- Keywords
- in vitro maturation, The SAIGON protocol, fresh embryo transfer, GnRH-Antagonist, frozen embryo transfer
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVM-Fresh (No gonadotropin + Fresh embryo transfer)Procedure or surgery
Patients randomized to this arm will receive estradiol valerate 8 mg/day. IVM will be performed after ≥10 days of estrogen and ET ≥8 mm. From the day of ICSI, they will continue estradiol and start vaginal progesterone 800 mg/day + dydrogesterone (20mg/day). A fresh embryo transfer will subsequently be performed.
IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)Procedure or surgery
Patients randomized into this group will receive FSH at a dose of 150 IU/day. Oocyte retrieval will be performed once the criteria for triggering are fulfilled, followed by embryo cryopreservation and frozen embryo transfer in the subsequent cycle. Endometrial preparation for frozen embryo transfer will be conducted using an exogenous steroids regimen. Patients will receive estradiol 8 mg/day starting from cycle days 2-3 for 10 days. When the endometrial thickness reaches ≥8 mm, luteal phase support will be initiated with vaginal progesterone 800 mg/day plus dydrogesterone 20 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| IVM-Fresh (No gonadotropin + Fresh embryo transfer) | Experimental | Endometrial preparation will be conducted using an artificial cycle protocol initiated on day 2-4 of the menstrual cycle (either spontaneous or induced). CAPA-IVM treatment will subsequently be performed, followed by oocyte fertilization and fresh embryo transfer. Receives: Procedure: IVM-Fresh (No gonadotropin + Fresh embryo transfer) |
| IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer) | Active comparator | Ovarian stimulation will be performed using a GnRH-antagonist protocol starting on any day of the menstrual cycle. Embryos obtained from ICSI will be cryopreserved for later transfer. Receives: Procedure: IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rates after the one embryo transfer
Live birth was defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Live births refer to the individual newborn; for example, a twin delivery represents two live births.
Measured: At 24 weeks of gestation
Secondary outcomes (28)
Cumulative ongoing pregnancy
Cumulative ongoing pregnancy defined as the occurrence of at least one ongoing pregnancy within 12 months of follow-up after randomisation. An ongoing pregnancy is counted as 1 for each participant who achieves at least one such pregnancy within this time frame, regardless of the number of embryo transfers or pregnancies achieved. Participants who do not return for embryo transfer within the 12-month period are considered censored
Measured: After 12 months of follow-up after randomisation
Time to ongoing pregnancy
Time to ongoing pregnancy defined as the interval between randomization and the achievement of an ongoing pregnancy.
Measured: Up to 10 weeks after embryo placement
Positive pregnancy test rate
Positive pregnancy test rate defined as serum human chorionic gonadotropin level ≥ 25 mIU/mL.
Measured: 10-14 days after embryo transfer
Clinical pregnancy rate
A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. In addition to intra-uterine pregnancy, it includes a clinically documented ectopic pregnancy.
Measured: 6 weeks after embryo transfer
Ongoing pregnancy rate
A pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat at 12 weeks gestation or beyond
Measured: 12 weeks after embryo transfer
Implantation rate
The number of gestational sacs observed divided by the number of embryos transferred (usually expressed as a percentage)
Measured: 3 weeks after embryo transfer
Ectopic pregnancy rate
A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology.
Measured: 2 - 4 weeks after embryo transfer
Miscarriage rate
Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age, in which the embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus.
Measured: 2-22 weeks after embryo transfer
Multiple gestations rate
A pregnancy with more than one embryo or fetus
Measured: 5 weeks after embryo transfer
Multiple birth rate
The complete expulsion or extraction from a woman of more than one fetus, after 22 completed weeks of gestational age, irrespective of whether it is a live birth or stillbirth. Births refer to the individual newborn; for example, a twin delivery represents two births.
Measured: At 22 weeks' gestation
Mode of delivery
Vaginal delivery, Assisted vaginal delivery, C-section
Measured: At delivery
Birth weight
Weight of the newborn measured right after delivery
Measured: At delivery
Gestational age at birth
Calculated by gestational age of all live births
Measured: At delivery
Ovarian hyperstimulation syndrome
Ovarian hyperstimulation syndrome (OHSS) is a potentially lethal iatrogenic complication of the early luteal phase or/and early pregnancy after ovulation induction or ovarian stimulation. OHSS was evaluated if symptoms were reported by the patient.
Measured: Up to 1 week after the oocyte retrieval in the IVF arm
IVM oocyte retrieval cancellation
Record the reason for canceling in IVM arm
Measured: After 21 day of endometrial preparation
Embryo transfer cancellation
Record the reason for canceling.
Measured: After 21 days of endometrial preparation
Preterm birth
Defined as delivery at <28, <32, <37 completed weeks. A birth that takes place after 22 weeks and before 37 completed weeks of gestational age.
Measured: At delivery
Gestational diabetes mellitus
A 75-g OGTT, with plasma glucose measurement when the patient is fasting and at 1 and 2 h, at 24-28 weeks of gestation in women not previously diagnosed with diabetes.
Measured: At 24-28 weeks of gestation
Hypertensive disorders of pregnancy
Pregnancy-induced hypertension, pre-eclampsia (early and late), eclampsia, and HELLP syndrome
Measured: After 20 weeks of gestation
Stillbirth
The death of a fetus before the complete expulsion or extraction from its mother after 28 completed weeks of gestational age. The death is determined by the fact that, after such separation, the fetus does not breathe or show any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles. It includes deaths occurring during labor.
Measured: At delivery after 28 weeks of gestation
Very low birth weight
Birth weight less than 1.500 g.
Measured: At delivery
Low birth weight
Birth weight less than 2.500 g
Measured: At delivery
High birth weight
Implies growth beyond an absolute birth weight of 4.000 g, regardless of the gestational age
Measured: At delivery
Very high birth weight
Birth weight over 4.500 g.
Measured: At delivery
Major congenital abnormalities
Structural, functional, and genetic anomalies that occur during pregnancy, and are identified antenatally, at birth, or later in life, and require surgical repair of a defect, or are visually evident, or life-threatening, or cause death. Any congenital anomaly will be included as follows definition of congenital abnormalities in Surveillance of Congenital Anomalies by Division of Birth Defects and Developmental Disabilities, NCBDDD, Centers for Disease Control and Prevention (2020).
Measured: During pregnancy and 12 months after delivery
Postpartum hemorrhage
Defined as a blood loss of ≥ 1000 mL, or blood loss accompanied by signs or symptoms of hypovolemia, within 24 hours after birth (including intrapartum blood loss), regardless of the mode of delivery.
Measured: Up to one month after the delivery
NICU admission
The admission of the newborn to the NICU
Measured: Up to one month after the delivery
Neonatal mortality
Death of a live-born baby within 28 days of birth. This can be divided into early neonatal mortality, if death occurs in the first seven days after birth, and late neonatal if death occurs between 8 and 28 days after delivery.
Measured: Up to one month after the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start22 Sep 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion15 Jan 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
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan N Vuong, MD, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171970
- Sponsor's protocol ID
- 10/25/DD-BVMD
- Acronym
- SAIGON-PTC
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of In Vitro Maturation With Fresh Embryo Transfer (The SAIGON Protocol) Versus In Vitro Fertilization With Frozen Embryo Transfer in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07171970
- Acronym / sponsor ID
- SAIGON-PTC / 10/25/DD-BVMD
- Keywords
- in vitro maturation, The SAIGON protocol, fresh embryo transfer, GnRH-Antagonist, frozen embryo transfer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 15 Sep 2025 (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.
Assisted Reproductive Technologies (ART) aim to increase success rates while minimizing patient risks. For women with high AFC or PCOS, conventional IVF carries a high risk of OHSS (Ho et al., 2019). A modern IVF strategy to prevent this uses a GnRH agonist trigger, requiring a "freeze-all" and subsequent FET (Wong et al., 2017). This reduces OHSS risk but can increase time to pregnancy (Vuong et al., 2021) and treatment burden.
IVM is a patient-friendly alternative that eliminates OHSS risk by avoiding high-dose gonadotropins. A 2020 trial by Vuong et al. compared CAPA-IVM-FET to conventional IVF-FET in women with high AFC. IVM yielded a comparable live birth rate (35.2%) versus IVF (43.2%), with a 0% OHSS rate in IVM compared to 0.7% in IVF (Vuong et al., 2020).
The optimal transfer method (fresh or frozen) in IVM cycles is debated. A 2021 pilot RCT by Vuong et al. found a freeze-only strategy after CAPA-IVM led to a significantly higher live birth rate (60%) than a fresh transfer (20%) (Vuong et al., 2021), but increased time to pregnancy (194 vs. 150 days) (Vuong et al., 2021). A refined CAPA-IVM protocol, which uses no gonadotropins, allowed for fresh embryo transfer in the same cycle, resulting in a numerically higher ongoing pregnancy rate (43.3% vs. 33.3%) than FET (Vuong et al., 2025).
This raises an important question: how does a simplified IVM strategy with fresh transfer compare to the established "safety-net" IVF strategy with FET? These two approaches represent opposing clinical philosophies. No large-scale study has yet compared them in women with PCOS. Therefore, this study is designed to compare the SAIGON protocol (gonadotropin-free CAPA-IVM with fresh ET) against a standard GnRH-antagonist IVF protocol with agonist trigger and subsequent FET.
Detailed description
- Screening for eligibility and randomization: Women who are potentially eligible are provided with information about the trial. Screening is done on the day of the first visit, and patients are given informed consent form to sign before enrollment. Participants are then randomly assigned (1:1) to either the CAPA-IVM or IVF-FET group.
- After randomisation 2.1. IVM-FRESH (The SAIGON Protocol):
- Treatment begins on day 2-4 of the menstrual cycle.
- Endometrial preparation uses oral estradiol valerate (Progynova®; Delpharm Lille SAS, France) 8mg/day for at least 10 days.
- Immature oocyte retrieval is performed when the endometrial thickness is ≥ 8 mm.
- Mature oocytes are fertilized via ICSI.
- Luteal phase support is provided with vaginal progesterone (800 mg/day) + dydrogesterone (20mg/day) starting on the day of ICSI.
- A fresh embryo transfer is performed three or five days after progesterone administration, depending on the embryo stage. 2.2. IVF-FET (Frozen Transfer Protocol):
- This protocol uses a random start approach, beginning on the day of the patient's first visit.
- Ovarian stimulation is done using a GnRH antagonist protocol with a starting dose of 150 IU/day of rFSH.
- A GnRH agonist trigger is administered when at least two leading follicles reach ≥ 17 mm in diameter.
- Insemination is performed using ICSI for matured oocytes.
- The endometrium is prepared for frozen embryo transfer using oral oestradiol valerate (8mg/day) and vaginal progesterone (800 mg/day) + dydrogesterone (20mg/day) when endometrial thickness is ≥ 8 mm.
- Surviving embryos are thawed and transferred two hours after thawing under ultrasound guidance.
- Pregnancy and outcomes:
- A pregnancy test is performed 10-14 days after embryo transfer. A positive result is a serum hCG level of ≥ 25 mIU/mL.
- Both groups continue hormone supplementation if the pregnancy test is positive.
- The primary outcome of the study is the live birth rate after one embryo transfer. Secondary outcomes include cumulative ongoing pregnancy, time to ongoing pregnancy, clinical pregnancy rate, miscarriage, and other treatment and pregnancy complications.
- Obstetric and neonatal outcomes: All data relating to the delivery process and neonatal care will be recorded by the data management system of IVFMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| IVM-Fresh (No gonadotropin + Fresh embryo transfer) | Experimental | Procedure: IVM-Fresh (No gonadotropin + Fresh embryo transfer)Endometrial preparation will be conducted using an artificial cycle protocol initiated on day 2-4 of the menstrual cycle (either spontaneous or induced). CAPA-IVM treatment will subsequently be performed, followed by oocyte fertilization and fresh embryo transfer. |
| IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer) | Active comparator | Procedure: IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)Ovarian stimulation will be performed using a GnRH-antagonist protocol starting on any day of the menstrual cycle. Embryos obtained from ICSI will be cryopreserved for later transfer. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18 - 42 years old.
- Diagnosed with PCOS, followed Rotterdam 2003 criteria (Group TREP consensus workshop, 2004)
- Had fewer than three previous failed frozen embryo transfer (FET) cycles
- Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts.
- Agreeing to participate in the study
Key exclusion criteria (4 listed)
- Having allergy and contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease)
- Cycles with preimplantation genetic testing indication
- Oocyte donation cycles
- Having untreated uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus, large leiomyoma ≥5 cm in diameter; adenomyosis, endometrial polyp, hydrosalpinx).
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 |
|---|---|---|
| IVM-Fresh (No gonadotropin + Fresh embryo transfer)Patients randomized to this arm will receive estradiol valerate 8 mg/day. IVM will be performed after ≥10 days of estrogen and ET ≥8 mm. From the day of ICSI, they will continue estradiol and start vaginal progesterone 800 mg/day + dydrogesterone (20mg/day). A fresh embryo transfer will subsequently be performed. | Procedure or surgery | IVM-Fresh (No gonadotropin + Fresh embryo transfer) |
| IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)Patients randomized into this group will receive FSH at a dose of 150 IU/day. Oocyte retrieval will be performed once the criteria for triggering are fulfilled, followed by embryo cryopreservation and frozen embryo transfer in the subsequent cycle. Endometrial preparation for frozen embryo transfer will be conducted using an exogenous steroids regimen. Patients will receive estradiol 8 mg/day starting from cycle days 2-3 for 10 days. When the endometrial thickness reaches ≥8 mm, luteal phase support will be initiated with vaginal progesterone 800 mg/day plus dydrogesterone 20 mg/day. | Procedure or surgery | IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer) |
Primary outcome
Live birth rates after the one embryo transfer
Time frame: At 24 weeks of gestation
Live birth was defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Live births refer to the individual newborn; for example, a twin delivery represents two live births.
28 secondary outcomes
Cumulative ongoing pregnancy
Time frame: After 12 months of follow-up after randomisation
Time to ongoing pregnancy
Time frame: Up to 10 weeks after embryo placement
Positive pregnancy test rate
Time frame: 10-14 days after embryo transfer
Clinical pregnancy rate
Time frame: 6 weeks after embryo transfer
Ongoing pregnancy rate
Time frame: 12 weeks after embryo transfer
Implantation rate
Time frame: 3 weeks after embryo transfer
Ectopic pregnancy rate
Time frame: 2 - 4 weeks after embryo transfer
Miscarriage rate
Time frame: 2-22 weeks after embryo transfer
Multiple gestations rate
Time frame: 5 weeks after embryo transfer
Multiple birth rate
Time frame: At 22 weeks' gestation
Mode of delivery
Time frame: At delivery
Birth weight
Time frame: At delivery
Gestational age at birth
Time frame: At delivery
Ovarian hyperstimulation syndrome
Time frame: Up to 1 week after the oocyte retrieval in the IVF arm
IVM oocyte retrieval cancellation
Time frame: After 21 day of endometrial preparation
Embryo transfer cancellation
Time frame: After 21 days of endometrial preparation
Preterm birth
Time frame: At delivery
Gestational diabetes mellitus
Time frame: At 24-28 weeks of gestation
Hypertensive disorders of pregnancy
Time frame: After 20 weeks of gestation
Stillbirth
Time frame: At delivery after 28 weeks of gestation
Very low birth weight
Time frame: At delivery
Low birth weight
Time frame: At delivery
High birth weight
Time frame: At delivery
Very high birth weight
Time frame: At delivery
Major congenital abnormalities
Time frame: During pregnancy and 12 months after delivery
Postpartum hemorrhage
Time frame: Up to one month after the delivery
NICU admission
Time frame: Up to one month after the delivery
Neonatal mortality
Time frame: Up to one month after the delivery
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 1 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Lan N Vuong, MD, PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVM-Fresh (No gonadotropin + Fresh embryo transfer) and IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer) in people with Polycystic Ovary Syndrome (PCOS) and In Vitro Maturation of Oocytes, run by Mỹ Đức Hospital 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 5 inclusion and 4 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 1 Oct 2025. 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 Vu NA Ho, MD, PhD (+84935843336, bsvu.hna@myduchospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rates after the one embryo transfer (time frame: At 24 weeks of gestation). 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 1 Oct 2025.