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

NCT ID: NCT03463278

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-01

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Pregnancy, Ovarian

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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0-4 blastocysts

group A: cumulative pregnancy rate of 0-4 blastocysts vitrified

Pregnancy Rate

Intervention Type DIAGNOSTIC_TEST

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

Pregnancy Rate

Intervention Type DIAGNOSTIC_TEST

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

Pregnancy Rate

Intervention Type DIAGNOSTIC_TEST

The pregnancy and live birth rate according to number of blastocysts formed in our three groups

Interventions

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Pregnancy Rate

The pregnancy and live birth rate according to number of blastocysts formed in our three groups

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assisting Nature

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evangelos Papanikolaou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assisting Nature

Locations

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Assisting Nature

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Tatiana Chartomatsidou, MSc

Role: CONTACT

00302310424294

Facility Contacts

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Evaggelos Papanikolaou, MD, PhD

Role: primary

00302310424294

Nikos Peitsidis, MD, MSc

Role: backup

00306978410100

Other Identifiers

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Blastocyst-AN004

Identifier Type: -

Identifier Source: org_study_id

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