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Clinical Trials/NCT03463278
NCT03463278UnknownNot Applicable

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

Assisting Nature1 site in 1 country160 target enrollmentStarted: November 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
160
Locations
1
Primary Endpoint
Cumulative Live Birth rate according to blastulation rate

Study Overview

Brief Summary

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

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
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 39 Years (Adult)
Sex
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;
  • TESE sperm;
  • PGS cycles;
  • donor oocytes;
  • donor sperm

Outcomes

Primary Outcomes

Cumulative Live Birth rate according to blastulation rate

Time Frame: 5 days of embryo culture

Cumulative Live Birth rate according to blastulation rate

Secondary Outcomes

  • Cumulative Pregnancy rate according to blastulation rate(5 days of embryo culture)

Investigators

Sponsor
Assisting Nature
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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