Assisted Reproductive TechniquesNCT04531644
Double Stimulation in Women With Low Prognosis in ART
A study testing double stimulation and conventional ovarian stimulation in people with Assisted Reproductive Techniques, run by Tu Du Hospital at 1 site in Vietnam.
Trial summary
The main objective of this study is to compare the cumulative ongoing pregnancy rates of two different IVF protocols in women candidate for ART characterized by low prognosis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Assisted Reproductive Techniques
- What is being tested?
- double stimulation and conventional ovarian stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteVietnam
- Study dates
- 14 May 2020to 30 Mar 2024
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≤ 40.
- AMH ≥ 0.3 ng/ml and ≤ 1.2 ng/ml.
- OR 3 ≤ AFC ≤7.
- Normal shape of uterus (based on ultrasound).
- Body mass index within 28 - 37 kg/m2
Who cannot join
- Asherman's syndrome.
- Endometriosis.
- Leiomyomas distorting the endometrium
- Sperm extracted from surgical procedures (i.e. PESA, TESE).
- Patients refuse to continue participating in the study.
- Patients injected with wrong dose of gonadotropins during the treatment.
Show all 9Show fewer
- Serious complications or accidents arise forcing the patients to discontinue the treatments.
- Ovarian surgery
- Previous chemotherapy or pelvic irradiation
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Department of Infertility of Tu Du hospital
Ho Chi Minh City, 70000
Chau TM Le, PhD, 0084908429006, dr.lethiminhchau@gmail.com
Anh Q Nguyen, MMSc, 0084976137562, dr.anhquocnguyen@gmail.com
About this study
Official title: Impact of Double Stimulation (DuoStim) in Women Affected by Low Prognosis to Assisted Reproductive Technologies
The main objective of this study is to compare the cumulative ongoing pregnancy rates of two different IVF protocols in women candidate for ART characterized by low prognosis.
Read the detailed description
The patients will be allocated into two groups: control and study group _ In study group, patients will be treated by DuoStim protocol: The first phase of ovarian stimulation is started on the second day or third day of period. GnRH agonist will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. Five days later after oocyte retrieval, the second stimulation will be started. All embryos will be cryopreserved.
_ In control group, patients will be treated with antagonist protocol: The cycle of ovarian stimulation is started on the second day or third day of period. hCG will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. If serum progesterone on the day of trigger ≥ 1.5 ng/ml, all embryos will be cryostored; otherwise, fresh embryos will be transferred.
- Conditions
- Assisted Reproductive Techniques
- Being tested
- double stimulation, conventional ovarian stimulation
- Keywords
- double ovarian stimulation, low prognosis women, ongoing pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double stimulationProcedure or surgery
Also called DuoStim
the patients will be treated with two consecutive ovarian stimulations in one cycle
conventional ovarian stimulationProcedure or surgery
the patients will be treated with one conventional ovarian stimulation in one cycle
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | the patients in this group will be treated with double stimulation Receives: Procedure: double stimulation |
| Control | Active comparator | the patients in this group will be treated with conventional ovarian stimulation Receives: Procedure: conventional ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Ongoing pregnancy rate
calculated by the number of ongoing pregnancy patients divided by the total number of patients in appropriate group
Measured: week 11 - 14 of pregnancy
Secondary outcomes (6)
Pregnancy rate
beta-hCG test is positive
Measured: 2 weeks after embryo transfer
Ongoing pregnancy rate
defined as the pregnancy completed 11 - 14 weeks of gestation and having vital fetus
Measured: week 11 - 14 of pregnancy
Number of oocytes retrieved
Number of oocytes retrieved identified by the embryologists
Measured: 4 hours after occyte pick-up
Number of mature oocytes
Number of mature oocytes identified by the embryologists
Measured: 4 hours after oocyte pick-up
Number of competent embryos
Number of embryos that can be transferred
Measured: 3 days to 5 days after oocyte pick-up
Fertilization rate
number of fertilized oocyted divided by number of mature oocytes
Measured: 1 to 3 days after oocyte pick-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start14 May 2020
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Assisted Reproductive TechniquesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tu Du Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Le Thi Minh Chau, Tu Du Hospital
- Investigators
- Chau TM Le, PhD, Study director, Tu Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531644
- Sponsor's protocol ID
- CS/TD/20/05
- Status last verified
- Dec 2023
- First submitted
- 18 Aug 2020
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cardoso MCA, Evangelista A, Sartorio C, Vaz G, Werneck CLV, Guimaraes FM, Sa PG, Erthal MC. Can ovarian double-stimulation in the same menstrual cycle improve IVF outcomes? JBRA Assist Reprod. 2017 Sep 1;21(3):217-221. doi: 10.5935/1518-0557.20170042.
PubMed 28837031Kuang Y, Chen Q, Hong Q, Lyu Q, Ai A, Fu Y, Shoham Z. Double stimulations during the follicular and luteal phases of poor responders in IVF/ICSI programmes (Shanghai protocol). Reprod Biomed Online. 2014 Dec;29(6):684-91. doi: 10.1016/j.rbmo.2014.08.009. Epub 2014 Sep 6.
PubMed 25444501Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.
PubMed 26921622Ubaldi FM, Capalbo A, Vaiarelli A, Cimadomo D, Colamaria S, Alviggi C, Trabucco E, Venturella R, Vajta G, Rienzi L. Follicular versus luteal phase ovarian stimulation during the same menstrual cycle (DuoStim) in a reduced ovarian reserve population results in a similar euploid blastocyst formation rate: new insight in ovarian reserve exploitation. Fertil Steril. 2016 Jun;105(6):1488-1495.e1. doi: 10.1016/j.fertnstert.2016.03.002. Epub 2016 Mar 25.
PubMed 27020168
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Double Stimulation (DuoStim) in Women Affected by Low Prognosis to Assisted Reproductive Technologies
- ClinicalTrials.gov ID
- NCT04531644
- Acronym / sponsor ID
- CS/TD/20/05
- Conditions
- Assisted Reproductive Techniques
- Keywords
- double ovarian stimulation, low prognosis women, ongoing pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tu Du HospitalOther government
- Collaborators
- Federico II University, University of Medicine and Pharmacy at Ho Chi Minh City
- Study start
- 14 May 2020 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 28 Aug 2020 (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.
The main objective of this study is to compare the cumulative ongoing pregnancy rates of two different IVF protocols in women candidate for ART characterized by low prognosis.
Detailed description
The patients will be allocated into two groups: control and study group _ In study group, patients will be treated by DuoStim protocol: The first phase of ovarian stimulation is started on the second day or third day of period. GnRH agonist will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. Five days later after oocyte retrieval, the second stimulation will be started. All embryos will be cryopreserved.
_ In control group, patients will be treated with antagonist protocol: The cycle of ovarian stimulation is started on the second day or third day of period. hCG will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. If serum progesterone on the day of trigger ≥ 1.5 ng/ml, all embryos will be cryostored; otherwise, fresh embryos will be transferred.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Procedure: double stimulationthe patients in this group will be treated with double stimulation |
| Control | Active comparator | Procedure: conventional ovarian stimulationthe patients in this group will be treated with conventional ovarian stimulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age ≤ 40.
- AMH ≥ 0.3 ng/ml and ≤ 1.2 ng/ml.
- OR 3 ≤ AFC ≤7.
- Normal shape of uterus (based on ultrasound).
- Body mass index within 28 - 37 kg/m2
Key exclusion criteria (9 listed)
- Asherman's syndrome.
- Endometriosis.
- Leiomyomas distorting the endometrium
- Sperm extracted from surgical procedures (i.e. PESA, TESE).
- Patients refuse to continue participating in the study.
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 stimulationAlso: DuoStimthe patients will be treated with two consecutive ovarian stimulations in one cycle | Procedure or surgery | Study |
| conventional ovarian stimulationthe patients will be treated with one conventional ovarian stimulation in one cycle | Procedure or surgery | Control |
Primary outcome
Cumulative Ongoing pregnancy rate
Time frame: week 11 - 14 of pregnancy
calculated by the number of ongoing pregnancy patients divided by the total number of patients in appropriate group
6 secondary outcomes
Pregnancy rate
Time frame: 2 weeks after embryo transfer
Ongoing pregnancy rate
Time frame: week 11 - 14 of pregnancy
Number of oocytes retrieved
Time frame: 4 hours after occyte pick-up
Number of mature oocytes
Time frame: 4 hours after oocyte pick-up
Number of competent embryos
Time frame: 3 days to 5 days after oocyte pick-up
Fertilization rate
Time frame: 1 to 3 days after oocyte pick-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Results publication: PubMed 28837031Cardoso MCA, Evangelista A, Sartorio C, Vaz G, Werneck CLV, Guimaraes FM, Sa PG, Erthal MC. Can ovarian double-stimulation in the same menstrual cycle improve IVF outcomes? JBRA Assist Reprod. 2017 Sep 1;21(3):217-221. doi: 10.5935/1518-0557.20170042.
- Results publication: PubMed 25444501Kuang Y, Chen Q, Hong Q, Lyu Q, Ai A, Fu Y, Shoham Z. Double stimulations during the follicular and luteal phases of poor responders in IVF/ICSI programmes (Shanghai protocol). Reprod Biomed Online. 2014 Dec;29(6):684-91. doi: 10.1016/j.rbmo.2014.08.009. Epub 2014 Sep 6.
- Results publication: PubMed 26921622Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.
- Results publication: PubMed 27020168Ubaldi FM, Capalbo A, Vaiarelli A, Cimadomo D, Colamaria S, Alviggi C, Trabucco E, Venturella R, Vajta G, Rienzi L. Follicular versus luteal phase ovarian stimulation during the same menstrual cycle (DuoStim) in a reduced ovarian reserve population results in a similar euploid blastocyst formation rate: new insight in ovarian reserve exploitation. Fertil Steril. 2016 Jun;105(6):1488-1495.e1. doi: 10.1016/j.fertnstert.2016.03.002. Epub 2016 Mar 25.
- 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.
Chau TM Le, PhD study director
Tu Du 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 double stimulation and conventional ovarian stimulation in people with Assisted Reproductive Techniques, run by Tu Du 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 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: status not confirmed, as of the sponsor's last update on 6 Dec 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chau TM Le, PhD (+84908429006, dr.lethiminhchau@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Ongoing pregnancy rate (time frame: week 11 - 14 of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04531644, which also lists 4 linked publications.
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 6 Dec 2023.