A New Revolutionary 3-Injection- Protocol in Infertile Women
NCT ID: NCT03877185
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
100 participants
OBSERVATIONAL
2018-07-01
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ovarian Stimulation With FSH Alone Versus FSH Plus GnRH Antagonist in an Oocyte Donor/Recipient Programme
NCT05759871
Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Long Agonist Protocol
NCT03693534
Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation
NCT01319695
The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies
NCT03169166
Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Classical Antagonist Protocol
NCT03684421
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
Live birth rate
Live Birth Rate and Blastulation Rate according to the protocol of COS
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.
Live birth rate
Live Birth Rate and Blastulation Rate according to the protocol of COS
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Live birth rate
Live Birth Rate and Blastulation Rate according to the protocol of COS
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
Exclusion Criteria
* 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
22 Years
39 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assisting Nature
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Papanikolaou Evaggelos
Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Evaggelos Papanikolaou, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Assisting Nature
Robert Najdecki, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Assisting Nature
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assisting Nature
Thessaloniki, , Greece
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3-Injection-Protocol-AN008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.