NCT01271400

Brief Summary

The aim of this study is to track the outcome from the patients who had embryo cryopreservation as part of their Advanced Reproductive Technology (ART) treatment at West Coast Fertility Centers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 8, 2011

Status Verified

September 1, 2011

Enrollment Period

1.1 years

First QC Date

January 5, 2011

Last Update Submit

September 6, 2011

Conditions

Primary InfertilitySecondary InfertilityGenital Diseases, MaleGenital Diseases, Female

Keywords

Infertility treatmentsFrozen embryo transfers (FET).IVF.ART.CryopreservationSlow-FreezeFreeze / thaw survival ratesBlastocyst formationPregnancy

Outcome Measures

Primary Outcomes (1)

  • Freeze/Thawed survival rates

    * Freeze / thaw survival rates * Blastocyst formation rates * Pregnancy rate.

    When embryos thawed initiate

Eligibility Criteria

Age21 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infertility patients

You may qualify if:

  • Infertile women whose physician has recommended IVF and who agree to cryopreserve surplus embryos.
  • Cancer patients who wish to preserve their fertility prior to cancer treatments.
  • Recipients who wish to use frozen donor embryos.
  • A male partner whose semen analysis meets the clinic criteria for ICSI. Use of donor sperm is also acceptable.
  • Be willing and able to comply with the protocol for the duration of the study.
  • Have voluntarily provided written informed consent under WIRB.

You may not qualify if:

  • A patient may NOT be entered into the study if she presents with ANY of the following criteria:
  • Clinically significant systemic disease.
  • Known endometriosis Grade III - IV (ASRM classification).
  • Any previous cycle indicating a low response to gonadotropin stimulation (defined as retrieval of \< 10 eggs at retrieval)
  • Three or more previous ART cycles without a clinical pregnancy
  • Abnormal, undiagnosed, gynecological bleeding.
  • Previous ovarian surgery
  • Known allergy or hypersensitivity to recombinant gonadotropin preparations or any other study-related medications.
  • Verifiable substance abuse.
  • Simultaneous participation in another study protocol.
  • Current smoker.
  • An extrauterine pregnancy within the last 3 months before OCP treatment commences.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Coast Fertility Centers

Fountain Valley, California, 92708, United States

Location

MeSH Terms

Conditions

Genital Diseases, MaleGenital Diseases, Female

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesMale Urogenital DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • David G. Diaz, M.D.

    West Coast Fertility Centers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 6, 2011

Study Start

December 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 8, 2011

Record last verified: 2011-09

Locations

US(1)