Normal Oocyte DonorsNCT02208986
GnRHa Trigger in Asian Oocyte Donors- a Dose Finding Study
A study testing Triptorelin in people with Normal Oocyte Donors, run by Vietnam National University at 1 site in Vietnam.
Trial summary
The aim of this randomized single center study is to explore the most optimal dose of GnRHa used for triggering of final oocyte maturation in IVF. The study group will consist of oocyte donors who have GnRHa trigger as a standard trigger concept. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Normal Oocyte Donors
- What is being tested?
- Triptorelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteVietnam
- Study dates
- Aug 2014to Mar 2015
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Oocyte donors who meet the following criteria:
- Age 18 - 35
- BMI < 28kg/m2
- Normal ovarian reserve, defined by AMH > 1.25 ng/ml or AFC ≥ 6 measured within two months prior to stimulation start
- Receiving GnRH-antagonist protocol for ovarian stimulation,
- Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
- Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
Who cannot join
- Previous poor response (≤ 3 oocytes) after high dose FSH stimulation
- Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
- Concommitant use of either LH or hMG/uFSH preparations in study cycle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GnRHa Trigger in Asian Oocyte Donors Co-treated With a GnRH Antagonist - a Dose Finding Study
The aim of this randomized single center study is to explore the most optimal dose of GnRHa used for triggering of final oocyte maturation in IVF. The study group will consist of oocyte donors who have GnRHa trigger as a standard trigger concept.
Hypothesis: In an Asian oocyte donor population, the use of 0.2 mg, 0.3mg or 0.4 mg of GnRHa will lead to the retrieval of comparable numbers of mature oocytes (MII) and good quality embryos. Moreover, the reproductive outcome in the recipients will be similar regardless of the dose of GnRHa used for trigger.
Read the detailed description
Methods
A randomized controlled single center study. All oocyte donors, fulfilling the inclusion criteria, will be eligible for inclusion after randomization.
Stimulation, monitoring, oocyte pick-up in donors and embryo transfer in recipients On day two of the cycle, - i.e. prior to commencing stimulation with long acting FSH (Elonva) - donors will be randomized to one of three groups, using different doses of GnRHa (Triptorelin) for trigger. Stimulation will be performed according to the standard stimulation protocol of the clinic, using Elonva followed by co-treatment with a GnRH antagonist from day 5 of stimulation . The dose of Elonva used for stimulation will be either 100 or 150 µg according to the weight of the patient. The first transvaginal ultrasound scan (TVUS) will be performed after seven or eight days after the Elonva depot injection. As soon as two follicles have reached a size of ≥ 17mm, triggering of final oocyte maturation will be performed with one single bolus of Triptorelin, 0.2 mg, 0.3mg or 0.4 mg. The timing of the trigger will be 6 AM for all groups and the oocyte pick-up (OPU) will be performed after 34 hours, according to the usual practice of the clinic. Importantly, each patient will be asked to check the presence of an LH surge via a urine LH detection kit at 4 hours after the trigger bolus has been administered. Embryo transfer will be performed on day two in all recipients.
Study group I Stimulation according to the abovementioned and ovulation trigger with 0.2mg Triptorelin. All other procedures will be performed according to the practice of the clinic.
Study group II Stimulation according to the abovementioned and ovulation trigger with 0.3mg Triptorelin. All other procedures will be performed according to the practice of the clinic.
Study group III Stimulation according to the abovementioned and ovulation trigger with 0.4mg Triptorelin. All other procedures will be performed according to the practice of the clinic.
Randomization Randomization will be performed using sealed envelopes developed via a computer generated list with blocks of twelve. The randomization will be performed on day two of the cycle. Doctors will be blinded to the randomization, but not patients and nurses.
Follicular fluid (FF) collection FF from the first punctured follicle on each side will be collected and cryo-preserved at -20 degrees for subsequent analysis of steroids.
Granulosa cell gene-expression analysis Cumulus and mural granulosa cells will be preserved and snap-frozen from a sub-group of 10 patients in each group. The primary subsequent analysis will focus on possible differences in LHR gene expression according to GnRHa trigger dose.
- Conditions
- Normal Oocyte Donors
- Being tested
- Triptorelin
- Keywords
- GnRH antagonist, GnRH agonist trigger, Oocyte donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriptorelinDrug
Also called Diphereline 0.1 mg powder and solvent
Triptorelin is given by s.c injection for ovulation triggering.
| Study group | Role | What they receive |
|---|---|---|
| 0.2mg Triptorelin | Active comparator | Ovulation trigger with 0.2mg Triptorelin in one subcutaneous injection. Receives: Drug: Triptorelin |
| 0.3mg Triptorelin | Active comparator | Ovulation trigger with 0.3mg Triptorelin in one subcutaneous injection. Receives: Drug: Triptorelin |
| Active Comparator: 0.4mg Triptorelin | Active comparator | Ovulation trigger with 0.4mg Triptorelin in one subcutaneous injection. Receives: Drug: Triptorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature oocytes
Measured: 30 minutes after oocyte retrieval completed
Secondary outcomes (2)
Day of bleeding after oocyte pick-up
Measured: in 2 weeks after oocyte pick-up
Clinical pregnancy
Measured: 5 weeks 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 posted5 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionMar 2015
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 Normal Oocyte DonorsStudies 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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam National University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, The Fertility Clinic, Skive Regional Hospital, Denmark, Aarhus University Hospital, University of Southern Denmark
- Responsible party
- Principal investigator, Manh Tuong Ho, Vietnam National University
- Investigators
- Tuong M Ho, MD, Principal investigator, CGRH, School of Medicine, Vietnam National University HCMC, VietnamLan TN Vuong, MD, Principal investigator, Department of Obstetrics and Gynecology, University of Medicine and Pharmacy HCMC, Ho Chi Minh City, VietnamPeter Humaidan, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208986
- Sponsor's protocol ID
- NCKH/CGRH_01_2014
- Status last verified
- Feb 2017
- First submitted
- 29 Jul 2014
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vuong TN, Ho MT, Ha TD, Phung HT, Huynh GB, Humaidan P. Gonadotropin-releasing hormone agonist trigger in oocyte donors co-treated with a gonadotropin-releasing hormone antagonist: a dose-finding study. Fertil Steril. 2016 Feb;105(2):356-63. doi: 10.1016/j.fertnstert.2015.10.014. Epub 2015 Oct 31.
PubMed 26523330
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GnRHa Trigger in Asian Oocyte Donors Co-treated With a GnRH Antagonist - a Dose Finding Study
- ClinicalTrials.gov ID
- NCT02208986
- Acronym / sponsor ID
- NCKH/CGRH_01_2014
- Conditions
- Normal Oocyte Donors
- Keywords
- GnRH antagonist, GnRH agonist trigger, Oocyte donor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Vietnam National UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, The Fertility Clinic, Skive Regional Hospital, Denmark, Aarhus University Hospital, University of Southern Denmark
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Aug 2014 (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 aim of this randomized single center study is to explore the most optimal dose of GnRHa used for triggering of final oocyte maturation in IVF. The study group will consist of oocyte donors who have GnRHa trigger as a standard trigger concept.
Hypothesis: In an Asian oocyte donor population, the use of 0.2 mg, 0.3mg or 0.4 mg of GnRHa will lead to the retrieval of comparable numbers of mature oocytes (MII) and good quality embryos. Moreover, the reproductive outcome in the recipients will be similar regardless of the dose of GnRHa used for trigger.
Detailed description
Methods
A randomized controlled single center study. All oocyte donors, fulfilling the inclusion criteria, will be eligible for inclusion after randomization.
Stimulation, monitoring, oocyte pick-up in donors and embryo transfer in recipients On day two of the cycle, - i.e. prior to commencing stimulation with long acting FSH (Elonva) - donors will be randomized to one of three groups, using different doses of GnRHa (Triptorelin) for trigger. Stimulation will be performed according to the standard stimulation protocol of the clinic, using Elonva followed by co-treatment with a GnRH antagonist from day 5 of stimulation . The dose of Elonva used for stimulation will be either 100 or 150 µg according to the weight of the patient. The first transvaginal ultrasound scan (TVUS) will be performed after seven or eight days after the Elonva depot injection. As soon as two follicles have reached a size of ≥ 17mm, triggering of final oocyte maturation will be performed with one single bolus of Triptorelin, 0.2 mg, 0.3mg or 0.4 mg. The timing of the trigger will be 6 AM for all groups and the oocyte pick-up (OPU) will be performed after 34 hours, according to the usual practice of the clinic. Importantly, each patient will be asked to check the presence of an LH surge via a urine LH detection kit at 4 hours after the trigger bolus has been administered. Embryo transfer will be performed on day two in all recipients.
Study group I Stimulation according to the abovementioned and ovulation trigger with 0.2mg Triptorelin. All other procedures will be performed according to the practice of the clinic.
Study group II Stimulation according to the abovementioned and ovulation trigger with 0.3mg Triptorelin. All other procedures will be performed according to the practice of the clinic.
Study group III Stimulation according to the abovementioned and ovulation trigger with 0.4mg Triptorelin. All other procedures will be performed according to the practice of the clinic.
Randomization Randomization will be performed using sealed envelopes developed via a computer generated list with blocks of twelve. The randomization will be performed on day two of the cycle. Doctors will be blinded to the randomization, but not patients and nurses.
Follicular fluid (FF) collection FF from the first punctured follicle on each side will be collected and cryo-preserved at -20 degrees for subsequent analysis of steroids.
Granulosa cell gene-expression analysis Cumulus and mural granulosa cells will be preserved and snap-frozen from a sub-group of 10 patients in each group. The primary subsequent analysis will focus on possible differences in LHR gene expression according to GnRHa trigger dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.2mg Triptorelin | Active comparator | Drug: TriptorelinOvulation trigger with 0.2mg Triptorelin in one subcutaneous injection. |
| 0.3mg Triptorelin | Active comparator | Drug: TriptorelinOvulation trigger with 0.3mg Triptorelin in one subcutaneous injection. |
| Active Comparator: 0.4mg Triptorelin | Active comparator | Drug: TriptorelinOvulation trigger with 0.4mg Triptorelin in one subcutaneous injection. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 - 35
- BMI < 28kg/m2
- Normal ovarian reserve, defined by AMH > 1.25 ng/ml or AFC ≥ 6 measured within two months prior to stimulation start
- Receiving GnRH-antagonist protocol for ovarian stimulation,
- Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
Key exclusion criteria (3 listed)
- Previous poor response (≤ 3 oocytes) after high dose FSH stimulation
- Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
- Concommitant use of either LH or hMG/uFSH preparations in study cycle
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 |
|---|---|---|
| TriptorelinAlso: Diphereline 0.1 mg powder and solventTriptorelin is given by s.c injection for ovulation triggering. | Drug | 0.2mg Triptorelin, 0.3mg Triptorelin, Active Comparator: 0.4mg Triptorelin |
Primary outcome
Number of mature oocytes
Time frame: 30 minutes after oocyte retrieval completed
2 secondary outcomes
Day of bleeding after oocyte pick-up
Time frame: in 2 weeks after oocyte pick-up
Clinical pregnancy
Time frame: 5 weeks after oocyte pick-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Derived from this study: PubMed 26523330Vuong TN, Ho MT, Ha TD, Phung HT, Huynh GB, Humaidan P. Gonadotropin-releasing hormone agonist trigger in oocyte donors co-treated with a gonadotropin-releasing hormone antagonist: a dose-finding study. Fertil Steril. 2016 Feb;105(2):356-63. doi: 10.1016/j.fertnstert.2015.10.014. Epub 2015 Oct 31.
- Individual participant dataSharing planned: No
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.
Tuong M Ho, MD principal investigator
CGRH, School of Medicine, Vietnam National University HCMC, Vietnam
Lan TN Vuong, MD principal investigator
Department of Obstetrics and Gynecology, University of Medicine and Pharmacy HCMC, Ho Chi Minh City, Vietnam
Peter Humaidan, MD principal investigator
Aarhus University 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 Triptorelin in people with Normal Oocyte Donors, run by Vietnam National University 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 6 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of mature oocytes (time frame: 30 minutes after oocyte retrieval completed). 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 NCT02208986, 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 6 Feb 2017.