A New Revolutionary 3-Injection- Protocol in Infertile Women
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedOctober 8, 2020
October 1, 2020
3.4 years
March 14, 2019
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live birth rate according to stimulation protocol
Live birth rate according to stimulation protocol
Up to 38 weeks after embryo transfer
Secondary Outcomes (1)
Blastulation rate according to stimulation protocol
Up to 6 days post oocyte retrieval
Study Arms (2)
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).
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.
Interventions
Live Birth Rate and Blastulation Rate according to the protocol of COS
Eligibility Criteria
Women aged 22- 39, faced with infertility issues, meeting the above inclusion criteria.
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assisting Naturelead
Study Sites (1)
Assisting Nature
Thessaloniki, 57001, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evaggelos Papanikolaou, MD,PhD
Assisting Nature
- PRINCIPAL INVESTIGATOR
Robert Najdecki, MD,PhD
Assisting Nature
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic
Study Record Dates
First Submitted
March 14, 2019
First Posted
March 15, 2019
Study Start
July 1, 2018
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
October 8, 2020
Record last verified: 2020-10