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

Overview

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

Full Title of Study: “Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus the Long Agonist Protocol”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2021

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.

Interventions

  • Diagnostic Test: Clinical Pregnancy Rate
    • The Clinical Pregnancy, Live Birth Rate and Blastulation Rate according to the protocol of COS

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Clinical Pregnancy Rate according to stimulation protocol
    • Time Frame: 6 weeks to 42 weeks after embryo transfer
    • Clinical Pregnancy Rate according to stimulation protocol
  • 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 Measures

  • Live Birth Rate according to stimulation protocol
    • Time Frame: 6 weeks to 42 weeks after embryo transfer
    • Live Birth Rate according to stimulation protocol

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 39 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Assisting Nature
  • Provider of Information About this Clinical Study
    • Principal Investigator: Papanikolaou Evaggelos, Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic – Assisting Nature
  • Overall Official(s)
    • Evaggelos Papanikolaou, MD, PhD, Principal Investigator, Assisting Nature
    • Robert Najdecki, MD, PhD, Principal Investigator, Assisting Nature
  • Overall Contact(s)
    • Evaggelos Papanikolaou, MD,PhD, 00302310424294, drvagpapanikolaou@yahoo.gr

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