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

• Sponsor: Assisting Nature (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03463278
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Anticipated Duration (Months): 98
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy, Ovarian	Diagnostic Test: Pregnancy Rate

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 Design

• Study Type: Observational
• Anticipated Enrollment: 160 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Impact of Blastulation Rate in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate
• Actual Study Start Date: Nov 1, 2013
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Cumulative Live Birth rate according to blastulation rate [5 days of embryo culture]

   Cumulative Live Birth rate according to blastulation rate

Secondary Outcome Measures

1. Cumulative Pregnancy rate according to blastulation rate [5 days of embryo culture]

   Cumulative Pregnancy rate according to blastulation rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 39 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assisting Nature	Thessaloníki		Greece	57001

Sponsors and Collaborators

• Assisting Nature

Investigators

• Principal Investigator: Evangelos Papanikolaou, MD, PhD, Assisting Nature

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assisting Nature
• ClinicalTrials.gov Identifier: NCT03463278
• Other Study ID Numbers: Blastocyst-AN004
• First Posted: Mar 13, 2018
• Last Update Posted: Oct 8, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assisting Nature: blastocyst; Freeze-all; IVF; Cumulative results; cumulative delivery rate
• Additional relevant MeSH terms: Pregnancy, Ovarian

Study Results

No Results Posted as of Oct 8, 2020