Diminished Ovarian ReserveDPOSNCT05847283
DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT
A study testing Dydrogesterone priming ovarian stiumulation protocol and GnRH antagonist protocol in people with Diminished Ovarian Reserve, run by Tam Anh TP. Ho Chi Minh General Hospital at 2 sites in Vietnam.
Trial summary
One of the barriers in patients with diminished ovarian reserve (DOR) is the significantly reduced number of oocytes resulting in fewer oocytes collected and embryos formed. Many ovarian stimulation strategies have been proposed to improve oocyte or embryo quantity which is oocyte accumulation could be a potential… Read more about this study
- Who is it for?
- Ages 18 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diminished Ovarian Reserve
- What is being tested?
- Dydrogesterone priming ovarian stiumulation protocol and GnRH antagonist protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 730 participants
- Where
- 2 sitesVietnam
- Study dates
- 22 Jun 2023to 31 Dec 2027
- 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 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman aged between 18 and 37 years
- AFC ≤ 5 and/or AMH ≤ 1.2 ng/ml
- Agree to perform freeze-all strategy and single frozen blastocyst embryo transfer
Who cannot join
- Oocyte recipient
- Indication of preimplantation genetic testing
- Known allergic reactions to medications in the Study (progesterone products, GnRH antagonist….)
- Basal FSH above 15mIU/mL.
- Have contraindications of ART treatment (e.g. critical or acute diseases)
- Retrieved sperm
Show all 9Show fewer
- Repeated Implantation failure ( ≥ 3 failed embryo transfers with good-quality embryos)
- Inability to comply with the study procedures.
- Patients with a history of thyroid cancer who are on hormone replacement therapy or those diagnosed with thyroid diseases at the time of eligibility assessment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
IVFTA
Hanoi, Hanoi, 100000
Nhu H Giang, MD, MCE, +84793231721, nhugh@tahospital.vn
Loc M T Nguyen, MSc, +84 39 2045478, locnmt@tahospital.vn
- Recruiting
Ivfta Hcmc
Ho Chi Minh City, Ho Chi Minh, 70000
Nhu H Giang, MD, MCE, +84793231721, nhugh@tahospital.vn
Loc M T Nguyen, MSc, +84 39 2045478, locnmt@tahospital.vn
About this study
Official title: Dydrogesterone Primed Ovarian Stimulation Versus Fixed Gonadotropin Releasing Hormone Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: A Randomized Controlled Trial
One of the barriers in patients with diminished ovarian reserve (DOR) is the significantly reduced number of oocytes resulting in fewer oocytes collected and embryos formed. Many ovarian stimulation strategies have been proposed to improve oocyte or embryo quantity which is oocyte accumulation could be a potential option with a comparable success rate and reasonable cost.
Progestin-primed ovarian stimulation (PPOS) protocol could be suggested as an alternative method of premature Luteinizing hormone (LH) prevention in IVF. It favors segment Assisted Reproductive Technology (ART) cycles such as frozen embryo transfer (FET), oocyte donor, fertility preservation, and oocyte accumulation set. The protocol is more patient-friendly and affordable than the GnRH antagonist regimen regarding LH suppression during ovarian stimulation.
Read more
Many PPOS protocols have been proposed in which the three most common agents include Dydrogesterone (DYG), Micronised Progesterone (MIP), and Medroxyprogesterone acetate (MPA). Indeed, DYG seems to have some advantages, including oral administration and safety which has been used in the treatment of threatened abortion. Initial evidence of PPOS protocol suggests that oocyte quantity and quality are comparable with other ovarian stimulation regimens. However, data related to the PPOS protocol has not been well documented, including Dydrogesteron-primed ovarian stimulation (DPOS).
There has not been an RCT with a large sample size and well-designed to provide more substantial evidence. A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF is urgently needed.
Read the detailed description
Screening for eligibility and randomization
- This trial will be conducted at Tam Anh TP. Ho Chi Minh General hospital, Ho Chi Minh City, Vietnam and Tam Anh General hospital, Ha Noi, Vietnam
- Women who are potentially eligible will be provided information about the trial when IVF treatment is indicated
- Patients will be provided information related to the study together with the informed consent documents. Signed informed consent forms will be obtained by the investigators from all women before the enrolment.
- Women will be randomized (1:1) to either DPOS or GnRH antagonist protocol
Ovarian stimulation
- The patients will be stimulated with the same protocol in all OS cycles after randomization.
- For DPOS arm (Group I): Patients will be co-administered with oral DYG (Duphaston) 30mg/d and Human Menopausal Gonadotrophin (hMG) 225 IU/day (IU/d) via intramuscular injection from menstrual cycle day 2 - 4 (CD2 - CD4) to the day of final oocyte maturation.
- For GnRH antagonist arm (Group II): In the fixed GnRH antagonist protocol, hMG 225 IU will be administered daily from menstrual cycle day 2 - 4 (CD2 - CD4). Daily administration of GnRH antagonist (Ganirelix 0.25 mg) will be initiated on the 5th day of stimulation. Treatment with hMG and GnRH antagonist will be continued daily until the day of final oocyte maturation triggering.
Oocytes retrieval and cryopreservation
- After 36 hours of final maturation injection, all follicles greater than 12mm in diameter will be aspirated.
- Oocyte cryopreservation will be applied to collect at least 7 ± 1 oocytes
- Matured oocytes will be frozen by vitrification (CRYOTEC® Method)
Oocyte thawing and ICSI
- For the last ovarian stimulation cycle, based on the aim to collect at least 7 ± 1 oocytes, the clinician will determine the last ovarian stimulation cycle on the day of final oocyte maturation.
- The frozen oocytes of the previous OS cycle will be thawed; all fresh and frozen oocytes will be fertilized by ICSI.
- The thawing process will follow the CRYOTEC® Method
- ICSI will be used for the fertilization of mature oocytes.
Embryo cryopreservation
- Both the fresh and frozen fertilized oocytes continue to culture in the CXCM medium (Irvine Scientific., USA) to blastocyst.
- Freeze-all strategy is applied in both arms, then the frozen embryo will be transferred in the next cycle.
Endometrium preparation and embryo transfer
- Endometrial preparation with hormonal replacement therapy will be performed. In the following cycle, the endometrium will be prepared using oral estradiol valerate (Valiera®; Laboratories Recalcine) 6 mg/day starting from the second or third day of the menstrual cycle. The endometrial thickness will be monitored from day six onwards, and vaginal progesterone (Cyclogest®; Actavis) 800 mg/day plus dydrogesterone (Duphaston 10mg) at the dose of 10mg twice daily will be started when endometrial thickness reaches 8 mm or more. Elective single blastocyst transfer will be performed.
- Embryos will be thawed on the day of embryo transfer, five or six days after the start of progesterone depending on the day-5 or day-6 embryo, respectively. Embryos will be transferred into the uterine cavity under ultrasound guidance.
Pregnancy test and ultrasound to confirm fetal viability
- A pregnancy test will be performed by measuring the blood beta-hCG level 10 - 11 days after embryo transfer. If the pregnancy test is positive (≥25mIU/mL), the patient is indicated to use exogenous estrogen and progesterone until at least 12 weeks of gestation.
- A pregnancy ultrasound will be performed three weeks after the positive pregnancy test equal to 7 weeks of gestational age.
- The primary endpoint is ongoing pregnancy (11 - 12 weeks of gestation) after the first embryo transfer
- Conditions
- Diminished Ovarian Reserve
- Being tested
- Dydrogesterone priming ovarian stiumulation protocol, GnRH antagonist protocol
- Keywords
- Progestin priming ovarian stimulation, Oocyte accumulation, Diminished ovarian reserve, GnRH antagonist, Oocyte vitrification, Dydrogesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dydrogesterone priming ovarian stiumulation protocolProcedure or surgery
Also called DPOS protocol
Patients will be co-administered with oral DYG (Duphaston) 30mg/d and Human Menopausal Gonadotrophin (hMG) 225 IU/day (IU/d) via intramuscular injection from menstrual cycle day 2 - 4 (CD2 - CD4) to the day of final oocyte maturation.
GnRH antagonist protocolProcedure or surgery
Also called GnRHanta protocol
In the fixed GnRH antagonist protocol, hMG 225 IU will be administered daily from menstrual cycle day 2 - 4 (CD2 - CD4) and s.c. administration of GnRH antagonist (Ganirelix 0.25 mg) will be initiated daily on the 5th day of stimulation. Treatment with hMG and GnRH antagonist will be continued until the day of final oocyte maturation triggering.
| Study group | Role | What they receive |
|---|---|---|
| DPOS protocol | Active comparator | Women will receive oral Dydrogesterone 10mg (Duphaston 10mg) t.i.d daily from the first day of ovarian stimulation till the day of final oocyte maturation. Receives: Procedure: Dydrogesterone priming ovarian stiumulation protocol |
| GnRH antagonist protocol | Placebo comparator | Women will receive GnRH antagonist (Ganirelix 0.25mg) once subcutaneously daily from day 5 of ovarian stimulation till the day of final oocyte maturation Receives: Procedure: GnRH antagonist protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate after the first embryo transfer
Ongoing pregnancy is defined as pregnancy with a detectable heart rate at 11 - 12 weeks of gestation after the completion of the first transfer.
Measured: 11 - 12 weeks of gestation
Secondary outcomes (23)
Serum LH level
LH levels are measured on day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Measured: On day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Serum Estradiol level
Estradiol levels are measured on day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Measured: On day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Serum Progesterone level
Progesterone levels are measured on day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Measured: On day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Premature LH surge
Premature LH surge (PLS) is increased serum LH more than twice the baseline or more than 15 mIU/ml. The rate of Premature LH surge is defined as number of PLS appearances per number of ovarian stimulation cycles
Measured: on the day of trigger, an average of 2 weeks after FSH administration
Duration of ovarian stimulation
Number of ovarian stimulation days
Measured: From the day 1 of FSH administration to the day of trigger, an average of 2 weeks after FSH administration
Total dose of FSH
A number of international units of FSH are administrated during an ovarian stimulation cycle
Measured: From the day 1 of FSH administration to the day of trigger, an average of 2 weeks after FSH administration
Number of Cumulus-oocyte complex
Number of Cumulus-oocyte complexes after oocyte retrieval
Measured: On the oocyte retrieval day, an average of 2 weeks after FSH administration
Number of MII oocyte
Number of MII oocytes after denuding
Measured: On the oocyte retrieval day, an average of 2 weeks after FSH administration
Number of survival oocyte
Number of survival oocytes after thawing
Measured: On the oocyte retrieval day of the ovarian stimulation cycle for ICSI, an average of 2 weeks after FSH administration
Fertilization rate per oocyte inseminated/injected
Fertilization is defined as the appearance of two PN at 17±1 hour per inseminated/injected
Measured: On the oocyte retrieval day of the ovarian stimulation cycle for ICSI, an average of 2 weeks after FSH administration
Embryo-cleavage rate
Number of embryos on Day 3 after ICSI day
Measured: Day 3 after ICSI day
Blastocyst rate
Numbers of embryos on Day 5 and Day 6 after ICSI
Measured: Day 5 and Day 6 after ICSI day
Number of survival blastocyst
Number of survival embryos on Day 5 and Day 6 after thawing
Measured: Day 5 and Day 6 after ICSI day
Top-quality blastocyst rate
Numbers of embryos on Day 5 and Day 6 with good quality after ICSI
Measured: Day 5 and Day 6 after ICSI day
Positive pregnancy test
A positive pregnancy test is defined as a serum hCG level greater than 25 mIU/mL 11 days after the first transfer
Measured: 11 days after the first transfer
Implantation rate
Implantation rate is defined as the number of gestational sacs per number of embryos transferred 3 weeks after the first transfer
Measured: Within 12 weeks of gestation
Biochemical pregnancy
Biochemical pregnancy is defined as a pregnancy diagnosed only by the detection of beta hCG in serum or urine
Measured: Within 12 weeks of gestation
Miscarriage
Complete loss of clinical pregnancy at 12 weeks of gestation
Measured: Within 12 weeks of gestation
Multiple pregnancy rate
Multiple pregnancy rate is explained as two or more gestational sacs or positive heartbeats by transvaginal sonography 5 weeks after embryo placement
Measured: Within 12 weeks of gestation
Ectopic pregnancy rate
Ectopic pregnancy confirmed by sonography or laparoscopy at 12 weeks of gestation
Measured: Within 12 weeks of gestation
Adverse events
Adverse events regarding medications according to local information products
Measured: Through study completion of each individual patient, an average of 6 months
Drop-out
Drop-out is defined as any patient discontinuing the Study or the investigator withdrawing them from the Study for any reason.
Measured: Through study completion, approximately within 2 years
Quality of life score
Quality of life is assessed by Vietnamese WHO-BRIFE questionnaire
Measured: On day 1 of FSH administration of the first ovarian stimulation cycle for oocyte vitrification and on the trigger day of the ovarian stimulation cycle for ICSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start22 Jun 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies 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
- 730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tam Anh TP. Ho Chi Minh General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Nhu H Giang, Tam Anh TP. Ho Chi Minh General Hospital
- Investigators
- Nhu H Giang, MD., MCE, Principal investigator, Tam Anh TP. Ho Chi Minh General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847283
- Sponsor's protocol ID
- DYDR-C22-0313
- Acronym
- DPOS
- Status last verified
- Dec 2025
- First submitted
- 7 Apr 2023
- Last updated
- 10 Dec 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 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dydrogesterone Primed Ovarian Stimulation Versus Fixed Gonadotropin Releasing Hormone Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05847283
- Acronym / sponsor ID
- DPOS / DYDR-C22-0313
- Conditions
- Diminished Ovarian Reserve
- Keywords
- Progestin priming ovarian stimulation, Oocyte accumulation, Diminished ovarian reserve, GnRH antagonist, Oocyte vitrification, Dydrogesterone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 730 participants (estimated)
- Lead sponsor
- Tam Anh TP. Ho Chi Minh General HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 May 2023 (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.
One of the barriers in patients with diminished ovarian reserve (DOR) is the significantly reduced number of oocytes resulting in fewer oocytes collected and embryos formed. Many ovarian stimulation strategies have been proposed to improve oocyte or embryo quantity which is oocyte accumulation could be a potential option with a comparable success rate and reasonable cost.
Progestin-primed ovarian stimulation (PPOS) protocol could be suggested as an alternative method of premature Luteinizing hormone (LH) prevention in IVF. It favors segment Assisted Reproductive Technology (ART) cycles such as frozen embryo transfer (FET), oocyte donor, fertility preservation, and oocyte accumulation set. The protocol is more patient-friendly and affordable than the GnRH antagonist regimen regarding LH suppression during ovarian stimulation.
Many PPOS protocols have been proposed in which the three most common agents include Dydrogesterone (DYG), Micronised Progesterone (MIP), and Medroxyprogesterone acetate (MPA). Indeed, DYG seems to have some advantages, including oral administration and safety which has been used in the treatment of threatened abortion. Initial evidence of PPOS protocol suggests that oocyte quantity and quality are comparable with other ovarian stimulation regimens. However, data related to the PPOS protocol has not been well documented, including Dydrogesteron-primed ovarian stimulation (DPOS).
There has not been an RCT with a large sample size and well-designed to provide more substantial evidence. A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF is urgently needed.
Detailed description
Screening for eligibility and randomization
- This trial will be conducted at Tam Anh TP. Ho Chi Minh General hospital, Ho Chi Minh City, Vietnam and Tam Anh General hospital, Ha Noi, Vietnam
- Women who are potentially eligible will be provided information about the trial when IVF treatment is indicated
- Patients will be provided information related to the study together with the informed consent documents. Signed informed consent forms will be obtained by the investigators from all women before the enrolment.
- Women will be randomized (1:1) to either DPOS or GnRH antagonist protocol
Ovarian stimulation
- The patients will be stimulated with the same protocol in all OS cycles after randomization.
- For DPOS arm (Group I): Patients will be co-administered with oral DYG (Duphaston) 30mg/d and Human Menopausal Gonadotrophin (hMG) 225 IU/day (IU/d) via intramuscular injection from menstrual cycle day 2 - 4 (CD2 - CD4) to the day of final oocyte maturation.
- For GnRH antagonist arm (Group II): In the fixed GnRH antagonist protocol, hMG 225 IU will be administered daily from menstrual cycle day 2 - 4 (CD2 - CD4). Daily administration of GnRH antagonist (Ganirelix 0.25 mg) will be initiated on the 5th day of stimulation. Treatment with hMG and GnRH antagonist will be continued daily until the day of final oocyte maturation triggering.
Oocytes retrieval and cryopreservation
- After 36 hours of final maturation injection, all follicles greater than 12mm in diameter will be aspirated.
- Oocyte cryopreservation will be applied to collect at least 7 ± 1 oocytes
- Matured oocytes will be frozen by vitrification (CRYOTEC® Method)
Oocyte thawing and ICSI
- For the last ovarian stimulation cycle, based on the aim to collect at least 7 ± 1 oocytes, the clinician will determine the last ovarian stimulation cycle on the day of final oocyte maturation.
- The frozen oocytes of the previous OS cycle will be thawed; all fresh and frozen oocytes will be fertilized by ICSI.
- The thawing process will follow the CRYOTEC® Method
- ICSI will be used for the fertilization of mature oocytes.
Embryo cryopreservation
- Both the fresh and frozen fertilized oocytes continue to culture in the CXCM medium (Irvine Scientific., USA) to blastocyst.
- Freeze-all strategy is applied in both arms, then the frozen embryo will be transferred in the next cycle.
Endometrium preparation and embryo transfer
- Endometrial preparation with hormonal replacement therapy will be performed. In the following cycle, the endometrium will be prepared using oral estradiol valerate (Valiera®; Laboratories Recalcine) 6 mg/day starting from the second or third day of the menstrual cycle. The endometrial thickness will be monitored from day six onwards, and vaginal progesterone (Cyclogest®; Actavis) 800 mg/day plus dydrogesterone (Duphaston 10mg) at the dose of 10mg twice daily will be started when endometrial thickness reaches 8 mm or more. Elective single blastocyst transfer will be performed.
- Embryos will be thawed on the day of embryo transfer, five or six days after the start of progesterone depending on the day-5 or day-6 embryo, respectively. Embryos will be transferred into the uterine cavity under ultrasound guidance.
Pregnancy test and ultrasound to confirm fetal viability
- A pregnancy test will be performed by measuring the blood beta-hCG level 10 - 11 days after embryo transfer. If the pregnancy test is positive (≥25mIU/mL), the patient is indicated to use exogenous estrogen and progesterone until at least 12 weeks of gestation.
- A pregnancy ultrasound will be performed three weeks after the positive pregnancy test equal to 7 weeks of gestational age.
- The primary endpoint is ongoing pregnancy (11 - 12 weeks of gestation) after the first embryo transfer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPOS protocol | Active comparator | Procedure: Dydrogesterone priming ovarian stiumulation protocolWomen will receive oral Dydrogesterone 10mg (Duphaston 10mg) t.i.d daily from the first day of ovarian stimulation till the day of final oocyte maturation. |
| GnRH antagonist protocol | Placebo comparator | Procedure: GnRH antagonist protocolWomen will receive GnRH antagonist (Ganirelix 0.25mg) once subcutaneously daily from day 5 of ovarian stimulation till the day of final oocyte maturation |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Woman aged between 18 and 37 years
- AFC ≤ 5 and/or AMH ≤ 1.2 ng/ml
- Agree to perform freeze-all strategy and single frozen blastocyst embryo transfer
Key exclusion criteria (9 listed)
- Oocyte recipient
- Indication of preimplantation genetic testing
- Known allergic reactions to medications in the Study (progesterone products, GnRH antagonist….)
- Basal FSH above 15mIU/mL.
- Have contraindications of ART treatment (e.g. critical or acute diseases)
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 |
|---|---|---|
| Dydrogesterone priming ovarian stiumulation protocolAlso: DPOS protocolPatients will be co-administered with oral DYG (Duphaston) 30mg/d and Human Menopausal Gonadotrophin (hMG) 225 IU/day (IU/d) via intramuscular injection from menstrual cycle day 2 - 4 (CD2 - CD4) to the day of final oocyte maturation. | Procedure or surgery | DPOS protocol |
| GnRH antagonist protocolAlso: GnRHanta protocolIn the fixed GnRH antagonist protocol, hMG 225 IU will be administered daily from menstrual cycle day 2 - 4 (CD2 - CD4) and s.c. administration of GnRH antagonist (Ganirelix 0.25 mg) will be initiated daily on the 5th day of stimulation. Treatment with hMG and GnRH antagonist will be continued until the day of final oocyte maturation triggering. | Procedure or surgery | GnRH antagonist protocol |
Primary outcome
Ongoing pregnancy rate after the first embryo transfer
Time frame: 11 - 12 weeks of gestation
Ongoing pregnancy is defined as pregnancy with a detectable heart rate at 11 - 12 weeks of gestation after the completion of the first transfer.
23 secondary outcomes
Serum LH level
Time frame: On day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Serum Estradiol level
Time frame: On day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Serum Progesterone level
Time frame: On day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Premature LH surge
Time frame: on the day of trigger, an average of 2 weeks after FSH administration
Duration of ovarian stimulation
Time frame: From the day 1 of FSH administration to the day of trigger, an average of 2 weeks after FSH administration
Total dose of FSH
Time frame: From the day 1 of FSH administration to the day of trigger, an average of 2 weeks after FSH administration
Number of Cumulus-oocyte complex
Time frame: On the oocyte retrieval day, an average of 2 weeks after FSH administration
Number of MII oocyte
Time frame: On the oocyte retrieval day, an average of 2 weeks after FSH administration
Number of survival oocyte
Time frame: On the oocyte retrieval day of the ovarian stimulation cycle for ICSI, an average of 2 weeks after FSH administration
Fertilization rate per oocyte inseminated/injected
Time frame: On the oocyte retrieval day of the ovarian stimulation cycle for ICSI, an average of 2 weeks after FSH administration
Embryo-cleavage rate
Time frame: Day 3 after ICSI day
Blastocyst rate
Time frame: Day 5 and Day 6 after ICSI day
Number of survival blastocyst
Time frame: Day 5 and Day 6 after ICSI day
Top-quality blastocyst rate
Time frame: Day 5 and Day 6 after ICSI day
Positive pregnancy test
Time frame: 11 days after the first transfer
Implantation rate
Time frame: Within 12 weeks of gestation
Biochemical pregnancy
Time frame: Within 12 weeks of gestation
Miscarriage
Time frame: Within 12 weeks of gestation
Multiple pregnancy rate
Time frame: Within 12 weeks of gestation
Ectopic pregnancy rate
Time frame: Within 12 weeks of gestation
Adverse events
Time frame: Through study completion of each individual patient, an average of 6 months
Drop-out
Time frame: Through study completion, approximately within 2 years
Quality of life score
Time frame: On day 1 of FSH administration of the first ovarian stimulation cycle for oocyte vitrification and on the trigger day of the ovarian stimulation cycle for ICSI
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 10 Dec 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.
Nhu H Giang, MD., MCE principal investigator
Tam Anh TP. Ho Chi Minh General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dydrogesterone priming ovarian stiumulation protocol and GnRH antagonist protocol in people with Diminished Ovarian Reserve, run by Tam Anh TP. Ho Chi Minh General Hospital at 2 sites 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 3 inclusion and 9 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Nhu H Giang, MD., MCE (+84 793 231 721, nhugh@tahospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate after the first embryo transfer (time frame: 11 - 12 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 10 Dec 2025.