Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Long Agonist Protocol
1 other identifier
observational
120
1 country
1
Brief Summary
A prospective study of the evaluation of the clinical IVF (in vitro fertilization) results after following Long Antagonist protocol for Controlled Ovarian Stimulation (COS) versus following Long Agonist protocol
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 Feb 2017
Longer than P75 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
February 15, 2017
CompletedFirst Submitted
Initial submission to the registry
September 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedOctober 8, 2020
October 1, 2020
4.4 years
September 24, 2018
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical Pregnancy Rate according to stimulation protocol
Clinical Pregnancy Rate according to stimulation protocol
6 weeks to 42 weeks after embryo transfer
Number of formed blastocysts in each group of patients
The number of the formed blastocysts in each group of patients according to the COS protocol
5 days after the OPU day
Secondary Outcomes (1)
Live Birth Rate according to stimulation protocol
6 weeks to 42 weeks after embryo transfer
Study Arms (2)
Long Antagonist Protocol
Clinical Pregnancy Rate, Live Birth Rate and Blastulation Rate of patients who followed Long Antagonist Protocol for Controlled Ovarian Stimulation.
Long Agonist Protocol
Clinical Pregnancy Rate and Live Birth Rates and Blastulation Rate of patients who followed Long Agonist Protocol for Controlled Ovarian Stimulation.
Interventions
The Clinical Pregnancy, Live Birth Rate and Blastulation Rate according to the protocol of COS
Eligibility Criteria
Women 18- 39 years old who follow COS with the Long Antagonist Protocol or with Long Agonist Protocol
You may qualify if:
- primary infertility
- age 18-39 years; body mass index (BMI) 18-29kg/m2;
- regular menstrual cycle of 26-35days,
- 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;
- history of being a 'poor responder',
- defined as \>20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe OHSS in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assisting Naturelead
Study Sites (1)
Assisting Nature
Thessaloniki, 57001, Greece
MeSH Terms
Conditions
Condition 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
September 24, 2018
First Posted
October 3, 2018
Study Start
February 15, 2017
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
October 8, 2020
Record last verified: 2020-10