InfertilityNCT05765968
Cumulative Live Birth After Double Stimulation Protocol Versus Antagonist Protocol for Poor Ovarian Responders
A study testing Double Stimulation Protocol and Antagonist Stimulation Protocol in people with Infertility, run by Shandong University at 1 site in China.
Trial summary
To compare the difference in cumulative live birth rates within one year between double stimulations protocol and two-cycle antagonist protocol in poor ovarian responders. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Double Stimulation Protocol and Antagonist Stimulation Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,198 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2023to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women diagnosed with Poseidon criteria or expected poor ovarian responder （the number of oocyte retrieval ≤9）
- Women aged ≥20 years old
- Women who are undergoing their first or second ART cycles
- Women who are undergoing IVF,ICSI or PGT-A cycles
- Women with the number of oocyte retrieval ≤9 after their first ovarian stimulation cycle since radomization, and the number of follicle measuring 8mm or larger ≥3
Who cannot join
- Women with RIF or RSA
- Women diagnosed with uterine abnormalities including uterine malformations, adenomyosis, submucosal fibroids, uterine adhesions or endometrial polyps
- Women with untreated hydrosalpinx that is visible under pelvic ultrasound
- Women with chromosomal abnormalities, or women who are undergoning PGT-SR or PGT-M cycles
- Women with a history of canceled FET cycle(s) due to a thin endometrium (<7mm)
- Man with operation to get sperm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cumulative Live Birth Rates in the Same Cycle Double Stimulation Protocol Versus a Two-cycle Antagonist Stimulation Protocol in IVF Patients With a Poor Prognosis: a Randomized Clinical Trial
To compare the difference in cumulative live birth rates within one year between double stimulations protocol and two-cycle antagonist protocol in poor ovarian responders.
Read the detailed description
The theory of multicyclic development of follicles during the menstrual cycle prompted new approaches to ovarian stimulation such as double stimulation within the same menstrual cycle, in both follicular and luteal phases. The double ovarian stimulation protocol has been proposed to optimize the number of oocytes retrieved within the shortest possible timeframe.In general, the aim of DUOSTIM is to obtain the highest number of oocytes in the shortest time, thus avoiding waste of time, which is crucial for these patients.
- Conditions
- Infertility
- Being tested
- Double Stimulation Protocol, Antagonist Stimulation Protocol
- Keywords
- Poseidon criteria, Double stimulation, Cummulative live birth
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Stimulation ProtocolProcedure or surgery
cummulative live birth outcome after two cycles of in virto fertilization using double stimulation protocol, which refers to two cycles of ovarian stimulation in both follicular phase and luteal phase within the same menstrual cycle
Antagonist Stimulation ProtocolProcedure or surgery
cummulative live birth outcome within no more than two cycles of in virto fertilization using classical antagonist protocol
| Study group | Role | What they receive |
|---|---|---|
| Double Stimulation Protocol | Experimental | Double stimulations were performed during the follicular and luteal phases in the same cycle by rFSH\&hmg. Receives: Procedure: Double Stimulation Protocol |
| Antagonist Stimulation Protocol | Active comparator | The classical antagonist protocol were performed by rFSH,hmg and antagonist. Receives: Procedure: Antagonist Stimulation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth rate
Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions, and cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (up to 3 transfers of single blastocycst within 1 year after randomization), by the total number of women randomized to the specific group.
Measured: 36 months
Secondary outcomes (1)
Number of retrieved oocytes
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start14 Mar 2023 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- 1,198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Provincial Maternal and Child Health Care Hospital, Shenyang Jinghua Hospital, Xinjiang Jiayin Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Guangdong Second Provincial General Hospital, The Affiliated Hospital of Qingdao University, Wuhan Tongji Reproductive Medicine Hospital, Reproductive & Genetic Hospital of CITIC-Xiangya
- Responsible party
- Principal investigator, Chen Zi-Jiang, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765968
- Sponsor's protocol ID
- DouAnt
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 14 Mar 2023
- 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 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cumulative Live Birth Rates in the Same Cycle Double Stimulation Protocol Versus a Two-cycle Antagonist Stimulation Protocol in IVF Patients With a Poor Prognosis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05765968
- Acronym / sponsor ID
- DouAnt
- Conditions
- Infertility
- Keywords
- Poseidon criteria, Double stimulation, Cummulative live birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,198 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Hunan Provincial Maternal and Child Health Care Hospital, Shenyang Jinghua Hospital, Xinjiang Jiayin Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Guangdong Second Provincial General Hospital, The Affiliated Hospital of Qingdao University, Wuhan Tongji Reproductive Medicine Hospital, Reproductive & Genetic Hospital of CITIC-Xiangya
- Study start
- 14 Mar 2023 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 13 Mar 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.
To compare the difference in cumulative live birth rates within one year between double stimulations protocol and two-cycle antagonist protocol in poor ovarian responders.
Detailed description
The theory of multicyclic development of follicles during the menstrual cycle prompted new approaches to ovarian stimulation such as double stimulation within the same menstrual cycle, in both follicular and luteal phases. The double ovarian stimulation protocol has been proposed to optimize the number of oocytes retrieved within the shortest possible timeframe.In general, the aim of DUOSTIM is to obtain the highest number of oocytes in the shortest time, thus avoiding waste of time, which is crucial for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double Stimulation Protocol | Experimental | Procedure: Double Stimulation ProtocolDouble stimulations were performed during the follicular and luteal phases in the same cycle by rFSH\&hmg. |
| Antagonist Stimulation Protocol | Active comparator | Procedure: Antagonist Stimulation ProtocolThe classical antagonist protocol were performed by rFSH,hmg and antagonist. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women diagnosed with Poseidon criteria or expected poor ovarian responder （the number of oocyte retrieval ≤9）
- Women aged ≥20 years old
- Women who are undergoing their first or second ART cycles
- Women who are undergoing IVF,ICSI or PGT-A cycles
- Women with the number of oocyte retrieval ≤9 after their first ovarian stimulation cycle since radomization, and the number of follicle measuring 8mm or larger ≥3
Key exclusion criteria (6 listed)
- Women with RIF or RSA
- Women diagnosed with uterine abnormalities including uterine malformations, adenomyosis, submucosal fibroids, uterine adhesions or endometrial polyps
- Women with untreated hydrosalpinx that is visible under pelvic ultrasound
- Women with chromosomal abnormalities, or women who are undergoning PGT-SR or PGT-M cycles
- Women with a history of canceled FET cycle(s) due to a thin endometrium (<7mm)
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 |
|---|---|---|
| Double Stimulation Protocolcummulative live birth outcome after two cycles of in virto fertilization using double stimulation protocol, which refers to two cycles of ovarian stimulation in both follicular phase and luteal phase within the same menstrual cycle | Procedure or surgery | Double Stimulation Protocol |
| Antagonist Stimulation Protocolcummulative live birth outcome within no more than two cycles of in virto fertilization using classical antagonist protocol | Procedure or surgery | Antagonist Stimulation Protocol |
Primary outcome
Cumulative live birth rate
Time frame: 36 months
Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions, and cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (up to 3 transfers of single blastocycst within 1 year after randomization), by the total number of women randomized to the specific group.
1 secondary outcome
Number of retrieved oocytes
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double Stimulation Protocol and Antagonist Stimulation Protocol in people with Infertility, run by Shandong University at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 14 Mar 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative live birth rate (time frame: 36 months). 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 14 Mar 2023.