Subfertility, FemaleNCT02940535
Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response
A study testing Diphereline (Triptorelin embonate), Decapeptyl (Triptorelin) and human menopausal gonadotropin in people with Subfertility, Female and Ovulation Disorder, run by Navy General Hospital, Beijing at 1 site in China.
Trial summary
The management of the poor responder patients is very difficult. Currently, there is no any standard treatment for poor responder patients. The study is designed to test a modified GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation, compare with GnRHa ultra-short protocol. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Subfertility, Female, Ovulation Disorder
- What is being tested?
- Diphereline (Triptorelin embonate), Decapeptyl (Triptorelin) and human menopausal gonadotropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2020
- 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 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- At least two of the following three features must be present: i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC <7 follicles or AMH <1.1 ng/ml).
Who cannot join
- Contraindications for IVF/ICSI
- Contraindications for pregnancy
- Primary ovarian insufficiency
- AFC <3
- PGD/PGS
Trial locations and contacts
1 site in 1 country.
Wei Shang, Dr contact
China1 site
Navy General Hospital
Beijing, Beijing Municipality, 100048
Yunhai Chuai, Dr, +86-18810892004, wangyh85@foxmail.com
About this study
Official title: Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response: a Randomized Control Trial
The management of the poor responder patients is very difficult. Currently, there is no any standard treatment for poor responder patients. The study is designed to test a modified GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation, compare with GnRHa ultra-short protocol. This is a randomized controlled trial.
- Conditions
- Subfertility, Female, Ovulation Disorder
- Being tested
- Diphereline (Triptorelin embonate), Decapeptyl (Triptorelin), human menopausal gonadotropin, human chorionic gonadotropin
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphereline (Triptorelin embonate)Drug
Decapeptyl (Triptorelin)Drug
human menopausal gonadotropinDrug
human chorionic gonadotropinDrug
| Study group | Role | What they receive |
|---|---|---|
| Low Dose GnRHa | Experimental | Diphereline 0.375mg was administered in the early-luteal-phase. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the day 28. Receives: Drug: Diphereline (Triptorelin embonate); Drug: human menopausal gonadotropin; Drug: human chorionic gonadotropin |
| GnRHa Ultra-short Protocol | Active comparator | Decapeptyl 0.1mg was administered in the menstrual day 2 to 7. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the menstrual day 2. Receives: Drug: Decapeptyl (Triptorelin); Drug: human menopausal gonadotropin; Drug: human chorionic gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth
The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).
Measured: 3 years
Secondary outcomes (1)
clinical pregnancy rate
Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subfertility, FemaleStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunhai Chuai, Navy General Hospital, Beijing
- Investigators
- Wei Shang, Dr, Principal investigator, Navy General Hospital, BeijingYunhai Chuai, Dr, Principal investigator, Navy General Hospital, BeijingMingming Shu, Dr, Principal investigator, Navy General Hospital, BeijingMing Zhou, Dr, Principal investigator, Navy General Hospital, BeijingHuiming Han, Dr, Principal investigator, Navy General Hospital, BeijingMengnan Chen, Dr, Principal investigator, Navy General Hospital, BeijingLei Chen, Principal investigator, Navy General Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940535
- Sponsor's protocol ID
- SW001
- Status last verified
- Oct 2016
- First submitted
- 1 Aug 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Siristatidis CS, Yong LN, Maheshwari A, Ray Chaudhuri Bhatta S. Gonadotropin-releasing hormone agonist protocols for pituitary suppression in assisted reproduction. Cochrane Database Syst Rev. 2025 Jan 9;1(1):CD006919. doi: 10.1002/14651858.CD006919.pub5.
PubMed 39783453
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02940535
- Acronym / sponsor ID
- SW001
- Conditions
- Subfertility, Female, Ovulation Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 21 Oct 2016 (estimated)
- 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 management of the poor responder patients is very difficult. Currently, there is no any standard treatment for poor responder patients. The study is designed to test a modified GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation, compare with GnRHa ultra-short protocol. This is a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose GnRHa | Experimental | Drug: Diphereline (Triptorelin embonate), Drug: human menopausal gonadotropin, Drug: human chorionic gonadotropinDiphereline 0.375mg was administered in the early-luteal-phase. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the day 28. |
| GnRHa Ultra-short Protocol | Active comparator | Drug: Decapeptyl (Triptorelin), Drug: human menopausal gonadotropin, Drug: human chorionic gonadotropinDecapeptyl 0.1mg was administered in the menstrual day 2 to 7. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the menstrual day 2. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- At least two of the following three features must be present: i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC <7 follicles or AMH <1.1 ng/ml).
Key exclusion criteria (5 listed)
- Contraindications for IVF/ICSI
- Contraindications for pregnancy
- Primary ovarian insufficiency
- AFC <3
- PGD/PGS
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 |
|---|---|---|
| Diphereline (Triptorelin embonate) | Drug | Low Dose GnRHa |
| Decapeptyl (Triptorelin) | Drug | GnRHa Ultra-short Protocol |
| human menopausal gonadotropin | Drug | GnRHa Ultra-short Protocol, Low Dose GnRHa |
| human chorionic gonadotropin | Drug | GnRHa Ultra-short Protocol, Low Dose GnRHa |
Primary outcome
live birth
Time frame: 3 years
The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).
1 secondary outcome
clinical pregnancy rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Derived from this study: PubMed 39783453Siristatidis CS, Yong LN, Maheshwari A, Ray Chaudhuri Bhatta S. Gonadotropin-releasing hormone agonist protocols for pituitary suppression in assisted reproduction. Cochrane Database Syst Rev. 2025 Jan 9;1(1):CD006919. doi: 10.1002/14651858.CD006919.pub5.
- Individual participant dataSharing planned: Yes
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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.
Wei Shang, Dr contact
Wei Shang, Dr principal investigator
Navy General Hospital, Beijing
Yunhai Chuai, Dr principal investigator
Navy General Hospital, Beijing
Mingming Shu, Dr principal investigator
Navy General Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diphereline (Triptorelin embonate), Decapeptyl (Triptorelin) and human menopausal gonadotropin in people with Subfertility, Female and Ovulation Disorder, run by Navy General Hospital, Beijing 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 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2016. 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?
Contact Wei Shang, Dr (shang.wei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth (time frame: 3 years). 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 NCT02940535, which also lists 1 linked publication.
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 21 Oct 2016.