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IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

oocyte vitrification

embryo freezing

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

IVF patients
ovulation trigger with Decapeptyl 0.2 mg because of ovarian hyper-response: E2 on trigger day .12,000 pmol/l and/or >15 oocytes.
Normal uterus

Exclusion Criteria:

<20% fertilization rate

Sites / Locations

IVF Unit, Rambam medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

oocyte vitrification

embryo freezing

Arm Description

All retrieved mature oocytes will be vitrified.

All retrieved oocytes will be fertilized, and resulting embryos will be frozen.

Outcomes

Primary Outcome Measures

Fetal Heart Activity 1 Month Post Embryo Transfer

Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer

Secondary Outcome Measures

Full Information

NCT ID

NCT02026193

First Posted

December 30, 2013

Last Updated

May 20, 2015

Sponsor

Rambam Health Care Campus

1. Study Identification

Unique Protocol Identification Number

NCT02026193

Brief Title

IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rambam Health Care Campus

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The chances to achieve pregnancy after retrieving >15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle. The purpose of this study is to compare the outcome of these two approaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oocyte vitrification

Arm Type

Experimental

Arm Description

All retrieved mature oocytes will be vitrified.

Arm Title

embryo freezing

Arm Type

Active Comparator

Arm Description

All retrieved oocytes will be fertilized, and resulting embryos will be frozen.

Intervention Type

Procedure

Intervention Name(s)

oocyte vitrification

Intervention Type

Procedure

Intervention Name(s)

embryo freezing

Primary Outcome Measure Information:

Title

Fetal Heart Activity 1 Month Post Embryo Transfer

Description

Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer

Time Frame

1 month after embryo transfer

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: IVF patients ovulation trigger with Decapeptyl 0.2 mg because of ovarian hyper-response: E2 on trigger day .12,000 pmol/l and/or >15 oocytes. Normal uterus Exclusion Criteria: <20% fertilization rate

Facility Information:

Facility Name

IVF Unit, Rambam medical Center

City

Haifa

ZIP/Postal Code

31096

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

21828116

Citation

Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.

Results Reference

background

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IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing

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