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

Pregnancy, Ovarian Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03463278
• Other study ID #: Blastocyst-AN004
• Status: Recruiting
• Start date: November 1, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: Assisting Nature
• Contact: Tatiana Chartomatsidou, MSc
• Phone: 00302310424294
• Email: embryology[@]assistingnature.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy, Ovarian

Intervention

Diagnostic Test:
• Pregnancy Rate
The pregnancy and live birth rate according to number of blastocysts formed in our three groups

Locations

Country	Name	City	State
Greece	Assisting Nature	Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
Assisting Nature

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Live Birth rate according to blastulation rate	Cumulative Live Birth rate according to blastulation rate	5 days of embryo culture
Secondary	Cumulative Pregnancy rate according to blastulation rate	Cumulative Pregnancy rate according to blastulation rate	5 days of embryo culture