Reproductive EndocrinologyPhase 4AvantiNCT01888744
Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist
A Phase 4 study testing GnRH agonist, GnRH antagonist and hP-hMG in people with Reproductive Endocrinology and Fertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Reproductive Endocrinology, Fertility, Optimal Stimulation Protocol
- What is being tested?
- GnRH agonist, GnRH antagonist and hP-hMG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Jun 2013
- Phase
- Phase 4
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ≤ 39 years the day of oocyte retrieval
- BMI ≤ 29
- cycle rank 1
- menstrual cycle 25-36 days
- PGD or preimplantation genetic screening (PGS) requested
- ICSI
- Single embryo transfer (SET) on day 5
Who cannot join
- Polycystic Ovary Syndrome (PCOS) (according Rotterdam criteria)
- Hormonal disturbances
- Endometriosis grade III and IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Type of Ovarian Stimulation Protocol on PGD Results: a Prospective Randomised Trial
The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).
Read the detailed description
Patients will be randomized at the outpatient clinic in two groups.
- Being tested
- GnRH agonist, GnRH antagonist, hP-hMG, Human chorionic gonadotropin, Progesterone
- Keywords
- Intracytoplasmic sperm injection (ICSI), PGD, GnrH agonist, GnRH antagonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH agonistDrug
Also called Suprefact nasal spray
GnRH antagonistDrug
Also called Orgalutran or Cetrotide
hP-hMGDrug
Also called Menopur
Human chorionic gonadotropinDrug
Also called Pregnyl
induction of final oocyte maturation
ProgesteroneDrug
Also called Utrogestan vaginal tablets
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (GnRH agonist group) | Active comparator | The long GnRH agonist protocol starts on day 21 of the preceding cycle with the administration of GnRH agonist, Decapeptyl® 0,1 mg subcutaneously daily or buserelin acetate, Suprefact® 600 μg daily intranasal. The administration of highly purified human menopausal gonadotropin (hp-HMG), Menopur® 225 IU subcutaneously is started after three weeks of desensitization. The desensitization is checked by ultrasound (absence of cysts) and hormonal measurement (Estradiol levels < 80 pg/ml, FSH ≤ 10 IU/l and progesterone < 1,5ng/ml) Receives: Drug: GnRH agonist; Drug: hP-hMG; Drug: Human chorionic gonadotropin; Drug: Progesterone |
| Group 2 (GnRH antagonist group) | Active comparator | Ovarian stimulation is started at day 2 of the menstrual cycle with 225 IU of HMG (Menopur ®) subcutaneously. At day 6 of the stimulation GnRH antagonist (Orgalutran®) 0,25 mg subcutaneously is added. Basal hormonal status will be confirmed in the antagonist group before starting. Receives: Drug: GnRH antagonist; Drug: hP-hMG; Drug: Human chorionic gonadotropin; Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of day 3 embryos for biopsy available
Measured: up to 6 weeks
Secondary outcomes (2)
Number of mature cumulus-oocyte complexes
Measured: up to 6 weeks
clinical pregnancy rate
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startSep 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive EndocrinologyStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe Blockeel, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888744
- Sponsor's protocol ID
- 2010/010
- Acronym
- Avanti
- Status last verified
- Jun 2013
- First submitted
- 21 Jun 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Type of Ovarian Stimulation Protocol on PGD Results: a Prospective Randomised Trial
- ClinicalTrials.gov ID
- NCT01888744
- Acronym / sponsor ID
- Avanti / 2010/010
- Keywords
- Intracytoplasmic sperm injection (ICSI), PGD, GnrH agonist, GnRH antagonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Jun 2013 (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 our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).
Detailed description
Patients will be randomized at the outpatient clinic in two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (GnRH agonist group) | Active comparator | Drug: GnRH agonist, Drug: hP-hMG, Drug: Human chorionic gonadotropin, Drug: ProgesteroneThe long GnRH agonist protocol starts on day 21 of the preceding cycle with the administration of GnRH agonist, Decapeptyl® 0,1 mg subcutaneously daily or buserelin acetate, Suprefact® 600 μg daily intranasal. The administration of highly purified human menopausal gonadotropin (hp-HMG), Menopur® 225 IU subcutaneously is started after three weeks of desensitization. The desensitization is checked by ultrasound (absence of cysts) and hormonal measurement (Estradiol levels < 80 pg/ml, FSH ≤ 10 IU/l and progesterone < 1,5ng/ml) |
| Group 2 (GnRH antagonist group) | Active comparator | Drug: GnRH antagonist, Drug: hP-hMG, Drug: Human chorionic gonadotropin, Drug: ProgesteroneOvarian stimulation is started at day 2 of the menstrual cycle with 225 IU of HMG (Menopur ®) subcutaneously. At day 6 of the stimulation GnRH antagonist (Orgalutran®) 0,25 mg subcutaneously is added. Basal hormonal status will be confirmed in the antagonist group before starting. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- ≤ 39 years the day of oocyte retrieval
- BMI ≤ 29
- cycle rank 1
- menstrual cycle 25-36 days
- PGD or preimplantation genetic screening (PGS) requested
Key exclusion criteria (3 listed)
- Polycystic Ovary Syndrome (PCOS) (according Rotterdam criteria)
- Hormonal disturbances
- Endometriosis grade III and IV
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 |
|---|---|---|
| GnRH agonistAlso: Suprefact nasal spray | Drug | Group 1 (GnRH agonist group) |
| GnRH antagonistAlso: Orgalutran or Cetrotide | Drug | Group 2 (GnRH antagonist group) |
| hP-hMGAlso: Menopur | Drug | Group 1 (GnRH agonist group), Group 2 (GnRH antagonist group) |
| Human chorionic gonadotropinAlso: Pregnylinduction of final oocyte maturation | Drug | Group 1 (GnRH agonist group), Group 2 (GnRH antagonist group) |
| ProgesteroneAlso: Utrogestan vaginal tablets | Drug | Group 1 (GnRH agonist group), Group 2 (GnRH antagonist group) |
Primary outcome
Number of day 3 embryos for biopsy available
Time frame: up to 6 weeks
2 secondary outcomes
Number of mature cumulus-oocyte complexes
Time frame: up to 6 weeks
clinical pregnancy rate
Time frame: up to 9 months
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 28 Jun 2013.
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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 Phase 4 study testing GnRH agonist, GnRH antagonist and hP-hMG in people with Reproductive Endocrinology and Fertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 28 Jun 2013. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 day 3 embryos for biopsy available (time frame: up to 6 weeks). 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 28 Jun 2013.