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Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Long Agonist Protocol

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ClinicalTrials.gov Identifier: NCT03693534
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Papanikolaou Evaggelos, Assisting Nature

Study Description
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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

Condition or disease Intervention/treatment
Pregnancy, Ovarian Diagnostic Test: Clinical Pregnancy Rate

Detailed Description:
A prospective study of the clinical results in women who followed the Long Antagonist protocol for Controlled Ovarian Stimulation (COS) versus women who followed Long Agonist protocol, in an In Vitro Fertilization (IVF) try. In particular, the Clinical Pregnancy Rates (CPR) and Live Birth Rates (LBR) were estimated for the two groups of patients. The number of the formed blastocysts was also measured in each group of patients.
Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus the Long Agonist Protocol
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Long Antagonist Protocol
Clinical Pregnancy Rate, Live Birth Rate and Blastulation Rate of patients who followed Long Antagonist Protocol for Controlled Ovarian Stimulation.
 Diagnostic Test: Clinical Pregnancy Rate
The Clinical Pregnancy, Live Birth Rate and Blastulation Rate according to the protocol of COS
Long Agonist Protocol
Clinical Pregnancy Rate and Live Birth Rates and Blastulation Rate of patients who followed Long Agonist Protocol for Controlled Ovarian Stimulation.
 Diagnostic Test: Clinical Pregnancy Rate
The Clinical Pregnancy, Live Birth Rate and Blastulation Rate according to the protocol of COS


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Pregnancy Rate according to stimulation protocol [ Time Frame: 6 weeks to 42 weeks after embryo transfer ]
    Clinical Pregnancy Rate according to stimulation protocol

  2. Number of formed blastocysts in each group of patients [ Time Frame: 5 days after the OPU day ]
    The number of the formed blastocysts in each group of patients according to the COS protocol


Secondary Outcome Measures :
  1. Live Birth Rate according to stimulation protocol [ Time Frame: 6 weeks to 42 weeks after embryo transfer ]
    Live Birth Rate according to stimulation protocol


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women 18- 39 years old who follow COS with the Long Antagonist Protocol or with Long Agonist Protocol
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693534


Contacts
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Contact: Evaggelos Papanikolaou, MD,PhD 00302310424294 drvagpapanikolaou@yahoo.gr

Locations
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Greece
Assisting Nature Recruiting
Thessaloniki, Greece, 57001
Contact: Evaggelos Papanikolaou, MD, PhD    00302310424294    papanikolaou@assistingnature.gr   
Contact: Robert Najdecki, MD, PhD    00306936646464    rnajdecki@assistingnature.gr   
Sponsors and Collaborators
Assisting Nature
Investigators
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Principal Investigator: Evaggelos Papanikolaou, MD, PhD Assisting Nature
Principal Investigator: Robert Najdecki, MD, PhD Assisting Nature
More Information
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Responsible Party: Papanikolaou Evaggelos, Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic, Assisting Nature
ClinicalTrials.gov Identifier: NCT03693534    
Other Study ID Numbers: Long-Antagonist-AN005
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Papanikolaou Evaggelos, Assisting Nature:
Long Antagonist
Long agonist
clinical pregnancy rate
 live birth rate
ovarian stimulation
IVF
Additional relevant MeSH terms:
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Pregnancy, Ovarian
Pregnancy, Ectopic
Pregnancy Complications