Infertility, FemaleNCT03877185
A New Revolutionary 3-Injection- Protocol in Infertile Women
An observational study of Infertility, Female, run by Assisting Nature at 1 site in Greece.
Trial summary
This is a prospective randomised study of the evaluation of the clinical IVF results after following a new revolutionary 3-Injection- Protocol for controlled ovarian stimulation in infertile women. Read more about this study
- Who is it for?
- Ages 22 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Live birth rate
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2018to Dec 2021
- Phase
- Observational
- 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 22 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women aged 22- 39, faced with infertility issues, meeting the above inclusion criteria.
Who may be able to join
- primary infertility
- age 22-39 years;
- body mass index (BMI) 18-29kg/m2;
- regular menstrual cycle of 26-35 days,
- presumed to be ovulatory;
- early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).
Who cannot join
- women with diabetes and other metabolic disease
- women with heart disease, QT prolongation, heart failure
- elevated liver enzymes, liver failure, hepatitis
- women with inflammatory or autoimmune disease
- abnormal karyotype
- polycystic ovarian syndrome
- endometriosis stage III/IV
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Assisting Nature
Thessaloniki, 57001
Evaggelos Papanikolaou, MD, PhD, 00302310424294, papanikolaou@assistingnature.gr
Robert Najdecki, MD, PhD, 00306936646464, rnajdecki@assistingnature.gr
About this study
Official title: A New Revolutionary 3-Injection- Protocol in Infertile Women With a Single Long Acting GnRH Antagonist in the Luteal Phase, a Bolus Gonadotropin Injection in the Early Follicular Phase and a Single Triggering Dose.
This is a prospective randomised study of the evaluation of the clinical IVF results after following a new revolutionary 3-Injection- Protocol for controlled ovarian stimulation in infertile women.
Read the detailed description
A randomized prospective study focusing on infertile women undergoing ovarian stimulation for IVF, using Elonva (corifollitropin alfa) as part of two different stimulation protocols.
Women assigned to Protocol A receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the evening of day 3 of the cycle, followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response).
Women assigned to Protocol B are administered a single dose of Elonva (corifollitropin alfa) on day 2 of the cycle, followed by daily GnRH antagonist doses, fixed on day 7 of the cycle. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly.
Live Birth Rates are estimated for both groups of patients. The number of the formed blastocysts in each group is measured, as well.
- Conditions
- Infertility, Female
- Being tested
- Live birth rate
- Keywords
- IVF, infertility, long antagonist, long acting gonadotropin, corifollitropin alfa, ovarian stimulation
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live birth rateDiagnostic test
Also called Blastulation rate
Live Birth Rate and Blastulation Rate according to the protocol of COS
| Study group | Role | What they receive |
|---|---|---|
| 3-Injection-Protocol Group | Women in group A (3-Injection-Protocol Group) receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the early follicular phase followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response). Receives: Diagnostic Test: Live birth rate | |
| Multiple-Injection- Protocol Group | Women assigned to group B (Multiple- Injection- Protocol Group) are administered a single dose of Elonva (corifollitropin alfa) in the early follicular phase followed by daily GnRH antagonist doses, either fixed on day 6 of the stimulation cycle, or when 2 or 3 follicles over 12-14 mm are present. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly. Receives: Diagnostic Test: Live birth rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate according to stimulation protocol
Live birth rate according to stimulation protocol
Measured: Up to 38 weeks after embryo transfer
Secondary outcomes (1)
Blastulation rate according to stimulation protocol
Blastulation rate according to stimulation protocol
Measured: Up to 6 days post oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Jul 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assisting Nature
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Papanikolaou Evaggelos, Assisting Nature
- Investigators
- Evaggelos Papanikolaou, MD,PhD, Principal investigator, Assisting NatureRobert Najdecki, MD,PhD, Principal investigator, Assisting Nature
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877185
- Sponsor's protocol ID
- 3-Injection-Protocol-AN008
- Status last verified
- Oct 2020
- First submitted
- 14 Mar 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Revolutionary 3-Injection- Protocol in Infertile Women With a Single Long Acting GnRH Antagonist in the Luteal Phase, a Bolus Gonadotropin Injection in the Early Follicular Phase and a Single Triggering Dose.
- ClinicalTrials.gov ID
- NCT03877185
- Acronym / sponsor ID
- 3-Injection-Protocol-AN008
- Conditions
- Infertility, Female
- Keywords
- IVF, infertility, long antagonist, long acting gonadotropin, corifollitropin alfa, ovarian stimulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assisting NatureUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Mar 2019 (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.
This is a prospective randomised study of the evaluation of the clinical IVF results after following a new revolutionary 3-Injection- Protocol for controlled ovarian stimulation in infertile women.
Detailed description
A randomized prospective study focusing on infertile women undergoing ovarian stimulation for IVF, using Elonva (corifollitropin alfa) as part of two different stimulation protocols.
Women assigned to Protocol A receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the evening of day 3 of the cycle, followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response).
Women assigned to Protocol B are administered a single dose of Elonva (corifollitropin alfa) on day 2 of the cycle, followed by daily GnRH antagonist doses, fixed on day 7 of the cycle. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly.
Live Birth Rates are estimated for both groups of patients. The number of the formed blastocysts in each group is measured, as well.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-Injection-Protocol Group | – | Diagnostic Test: Live birth rateWomen in group A (3-Injection-Protocol Group) receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the early follicular phase followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response). |
| Multiple-Injection- Protocol Group | – | Diagnostic Test: Live birth rateWomen assigned to group B (Multiple- Injection- Protocol Group) are administered a single dose of Elonva (corifollitropin alfa) in the early follicular phase followed by daily GnRH antagonist doses, either fixed on day 6 of the stimulation cycle, or when 2 or 3 follicles over 12-14 mm are present. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly. |
Who may qualify
- Ages
- 22 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 22- 39, faced with infertility issues, meeting the above inclusion criteria.
Key inclusion criteria (6 listed)
- primary infertility
- age 22-39 years;
- body mass index (BMI) 18-29kg/m2;
- regular menstrual cycle of 26-35 days,
- presumed to be ovulatory;
Key exclusion criteria (7 listed)
- women with diabetes and other metabolic disease
- women with heart disease, QT prolongation, heart failure
- elevated liver enzymes, liver failure, hepatitis
- women with inflammatory or autoimmune disease
- abnormal karyotype
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 |
|---|---|---|
| Live birth rateAlso: Blastulation rateLive Birth Rate and Blastulation Rate according to the protocol of COS | Diagnostic test | 3-Injection-Protocol Group, Multiple-Injection- Protocol Group |
Primary outcome
Live birth rate according to stimulation protocol
Time frame: Up to 38 weeks after embryo transfer
Live birth rate according to stimulation protocol
1 secondary outcome
Blastulation rate according to stimulation protocol
Time frame: Up to 6 days post oocyte retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Evaggelos Papanikolaou, MD,PhD principal investigator
Assisting Nature
Robert Najdecki, MD,PhD principal investigator
Assisting Nature
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Assisting Nature at 1 site in Greece.
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 6 inclusion and 7 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 8 Oct 2020. 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 Greece. 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 Evaggelos Papanikolaou, MD,PhD (00302310424294, drvagpapanikolaou@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate according to stimulation protocol (time frame: Up to 38 weeks after embryo transfer). 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 8 Oct 2020.