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

October 6, 2020 updated by: Papanikolaou Evaggelos, Assisting Nature

Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus the Long Agonist Protocol

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 57001
        • Recruiting
        • Assisting Nature

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Pregnancy Rate according to stimulation protocol
Time Frame: 6 weeks to 42 weeks after embryo transfer
Clinical Pregnancy Rate according to stimulation protocol
6 weeks to 42 weeks after embryo transfer
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
5 days after the OPU day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assisting Nature

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2017

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

June 30, 2021

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (ACTUAL)

October 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Long-Antagonist-AN005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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