Oocyte Cryopreservation Registry (HOPE Registry)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00699400
First received: June 13, 2008
Last updated: December 9, 2013
Last verified: December 2013
Results First Received: May 16, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Oocyte Cryopreservation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Slow Freeze (One Cycle) Subjects who participated in one freezing cycle of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
Slow Freeze (Two Cycles) Subjects who participated in two freezing cycles of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
Vitrification (One Cycle) Subjects who participated in one freezing cycle of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
Vitrification (Two Cycles) Subjects who participated in two freezing cycles of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
Both (Slow Freeze and Vitrification) Participants who underwent both slow freezing and vitrification cycles (one cycle of each freezing technique).
Pre-freeze Discontinuations Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).

Participant Flow:   Overall Study
    Slow Freeze (One Cycle)     Slow Freeze (Two Cycles)     Vitrification (One Cycle)     Vitrification (Two Cycles)     Both (Slow Freeze and Vitrification)     Pre-freeze Discontinuations  
STARTED     42     3     138     6     4     11  
COMPLETED     42     3     138     6     4     0  
NOT COMPLETED     0     0     0     0     0     11  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects were analyzed based on the freeze cycle(s) that were used, therefore, the 4 subjects that used both types of cryopreservation techniques are summarized in both the slow freeze and vitrification arms. These 4 subjects will be double-counted in the "Total (calculated)" column.

Reporting Groups
  Description
Slow Freeze Subjects that participated in one or more slow-freeze cycles
Vitrification Subjects that participated in one or more vitrification cycles
Pre-Freeze Discontinuations Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
Total Total of all reporting groups

Baseline Measures
    Slow Freeze     Vitrification     Pre-Freeze Discontinuations     Total  
Number of Participants  
[units: participants]
  49     148     11     208  
Age, Customized [1]
[units: Participants]
       
<35 years     4     34     5     43  
35-37 years     3     24     2     29  
38-40 years     15     30     2     47  
41-42 years     4     26     0     30  
43-44 years     13     15     1     29  
> 44 years     10     19     1     30  
Gender  
[units: Participants]
       
Female     49     148     11     208  
Male     0     0     0     0  
BMI  
[units: Kg/m^2]
Mean ± Standard Deviation
  24.6  ± 5.2     23.4  ± 3.6     19.7  ± 0     23.7  ± 4.1  
Donor Age  
[units: Years]
Mean ± Standard Deviation
  25.1  ± 2.7     26.0  ± 2.8     NA  ± NA [2]   25.7  ± 2.8  
[1]

Four subjects underwent cryopreservation cycles for both slow-freezing and vitrification

11 Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze) are captured in the Pre-Freeze Discontinuation Arm.

[2] Values not available for Pre-freeze Discontinuation Arm. These participants withdrew before oocyte retrieval or the oocyte retrieval procedure failed (had no oocytes to freeze from themselves or from donors).



  Outcome Measures
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1.  Primary:   Thawing Cycle Level Live Birth Rate   [ Time Frame: Birth of one or more live babies ]

2.  Secondary:   Oocyte Level Live Birth Rate   [ Time Frame: Birth of one or more live babies ]

3.  Secondary:   Number of Live Babies   [ Time Frame: Birth of one or more live babies ]

4.  Secondary:   Number of Oocytes Frozen   [ Time Frame: At cryopreservation ]

5.  Secondary:   Number of Oocytes Thawed   [ Time Frame: At start of thawing cycle ]

6.  Secondary:   Oocyte Survival Rate   [ Time Frame: At time of fertilization ]

7.  Secondary:   Implantation Rate   [ Time Frame: At time of ultrasound after embryo transfer ]

8.  Secondary:   Number of Clinical Pregnancies   [ Time Frame: At time of ultrasound after embryo transfer ]

9.  Secondary:   Number of Miscarriages   [ Time Frame: Anytime after embryo transfer ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Mary C. Mahony, PhD, HCLD (AAB)
Organization: EMD Serono, Inc.
phone: 781.681.2438
e-mail: mary.mahony@emdserono.com


No publications provided


Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00699400     History of Changes
Other Study ID Numbers: 28599
Study First Received: June 13, 2008
Results First Received: May 16, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board