The Number of Blastocysts Formed in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate

October 6, 2020 updated by: Assisting Nature

The Impact of Blastulation Rate in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate

A prospective study of the blastulation rate in the outcome of the Freeze all strategy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A prospective study of the blastulation rate in women under the age of 40 years following Freeze all strategy, according to AMH levels and sperm parameters.

Study group 1: number of vitrified blastocysts 0-4 Study group 2: number of vitrified blastocysts 5-7 Study group 3: number of vitrified blastocysts >7

Study Type

Observational

Enrollment (Anticipated)

160

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
      • Thessaloníki, Greece, 57001
        • Recruiting
        • Assisting Nature
        • Contact:

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

20 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged 20-39 years old following blastocyst culture after ICSI cycle in Freeze all Strategy

Description

Inclusion Criteria:

  • primary infertility
  • age 20-39 years;
  • body mass index (BMI) 18-29kg/m2;
  • regular menstrual cycle of 26-35days,
  • presumed to be ovulatory;
  • >1mil/ml spermatozoa;
  • short antagonist protocol

Exclusion Criteria:

  • poor responders;
  • age ≥40;
  • TESE sperm;
  • PGS cycles;
  • donor oocytes;
  • donor sperm

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
0-4 blastocysts
group A: cumulative pregnancy rate of 0-4 blastocysts vitrified
Diagnostic test: Pregnancy Rate
The pregnancy and live birth rate according to number of blastocysts formed in our three groups
5-7 blastocysts
group B: cumulative pregnancy rate of 5-7 blastocysts vitrified
Diagnostic test: Pregnancy Rate
The pregnancy and live birth rate according to number of blastocysts formed in our three groups
>7 blastocysts
group C: cumulative pregnancy rate of >7 blastocysts vitrified
Diagnostic test: Pregnancy Rate
The pregnancy and live birth rate according to number of blastocysts formed in our three groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Live Birth rate according to blastulation rate
Time Frame: 5 days of embryo culture
Cumulative Live Birth rate according to blastulation rate
5 days of embryo culture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Pregnancy rate according to blastulation rate
Time Frame: 5 days of embryo culture
Cumulative Pregnancy rate according to blastulation rate
5 days of embryo culture

Collaborators and Investigators

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

Sponsor

Assisting Nature

Investigators

  • Principal Investigator: Evangelos Papanikolaou, MD, PhD, 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)

November 1, 2013

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 10, 2018

First Posted (Actual)

March 13, 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

  • Blastocyst-AN004

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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