Achieving pregnancy using fresh versus cryopreserved semen for donor insemination
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Achieving Pregnancy Using Fresh Versus Cryopreserved Semen for Donor Insemination. Blood Products Advisory Committee, 12/14/01 Emmet J. Lamb, M.D. Professor of Gyn- Ob, Emeritus Stanford University, Stanford, California. Indications in 2001 for donor insemination .

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Achieving pregnancy using fresh versus cryopreserved semen for donor insemination
Achieving Pregnancy Using Fresh Versus Cryopreserved Semen for Donor Insemination

Blood Products Advisory Committee, 12/14/01

Emmet J. Lamb, M.D.

Professor of Gyn- Ob, Emeritus

Stanford University, Stanford, California


Indications in 2001 for donor insemination
Indications in 2001for donor insemination

  • Azoospermia or severe oligospermia

    • ICSI not available

      • No sperm

      • Not successful

      • Too Costly

  • Genetic problem of male

  • No male partner


Variables that improve fecundity stratify in analysis
Variables that improve fecundity Stratify in analysis

  • Azoospermic Male

  • Young female

  • Normal female

  • Parous female

  • Short duration infertility

  • First cycle


Variables that can be changed to improve fecundity

Donor selection

Fertile

High motile sperm count

Good cryosurvival

Fresh sperm

Cryopreservation Methods

Sperm preparation

Insemination Methods

Ovulation monitoring

Cervical mucus and BBT

Urinary LH

Pelvic ultrasound

Ovulation enhancement

Clomiphene

Gonadotropins

Variables that can be changed to improve fecundity


Comparing fecundity
Comparing Fecundity

  • Cycle fecundity

    • Total pregnancies / Total cycles of exposure

    • Assumes constant hazard rate.

      • Easy calculation

      • Easy explanation

      • Close to reality

  • Kaplan Meier survival analysis

  • Cox proportional hazard regression analysis


Fresh versus thawed semen meta analysis of cycle fecundity
Fresh versus thawed semenMeta-analysis of cycle fecundity


Meta analysis summary statistics
Meta-analysisSummary Statistics

  • Total subjects 23,374

  • Summary odds ratio 0.62 (0.43 to 0.90)

  • 2p Fresh v. Thaw 0.011 (Z= -2.55)

  • Heterogeneity, Q 129 (Tau sq= 0.42)


Fresh versus thawed semen cumulative meta analysis
Fresh versus Thawed SemenCumulative Meta-analysis


Cycle fecundity with donor frozen semen in clomiphene or unstimulated cycles

Cycle fecundity with donor frozen semen in clomiphene or unstimulated cycles

O’Brien in Cochrane Library, 2001


Frozen semen
Frozen Semen

  • Lower fecundity = more cycles

    • More drop-outs

    • Fewer children

    • Greater use of limited resources

  • More multiple pregnancies if gonadotropin stimulation used to compensate for lower fecundity


The use of frozen semen to avoid hiv transmission
The use of frozen semen to avoid HIV transmission

  • Stanford University School of Medicine

    • Michael Payne

      • Health Research and Policy

    • Douglas Owens

      • Internal Medicine and HRP

    • Emmet Lamb

      • Gynecology and Obstetrics


Methods of study
Methods of study

  • Gauge health benefit in terms of QALYs gained

    • Assign quality-adjusted utility to health states

    • Calculate quality-adjusted life expectancy

    • Discount utilities at 3%

  • Gold, et al. Cost-effectiveness in Health and Medicine. Oxford University Press , 1996


Markov model
Markov model

  • Events unfold over time at fixed intervals -- insemination cycles

  • Cohort of 80,000 women

    • Monthly cycles (insemination) up to 12

    • Yearly follow-up for a lifetime

  • Two treatment options

    • Frozen semen. Donor screened twice with EIA

    • Fresh semen. Donor screened once with EIA.


Probability of transmission of hiv 1 by insemination
Probability of Transmission of HIV-1 by insemination

Product of two elements:

  • Probability of infection from 1 insemination with an infected donor

  • Probability of an infected donor

    • Sum of two elements

      • Missed by EIA: Prevalence of HIV X (1-sensitivity) EIA

      • In window and not “False” Positive : Prevalence of window donors X specificity


Heterosexual transmission
Heterosexual transmission

  • Uninfected partners of infected men

  • Per episode risk = 1 in 500 to 1 in 1000

    • Mastro & Kitayaporn. Aids Research & Human Retroviruses 1998;14 (Suppl 3):S223-7

    • Royce, Sena, Cates, Cohen. New Engl J Med 1997;336:1072-8


Valleroy. FDA BPAC, 12/14/01

Payne, Owens, Lamb. In review 2001.


Prevalence of donors in the window period
Prevalence of donors in the window period

  • 50,000 new HIV cases in males

    • 35,000 high risk.

    • 8,750 (25%) escape screen (by self selection, history, STD tests)

  • + 8,750 high risk

  • + 15,000 low risk

  • = 23,750 infected potential donors

    Peterson, et al Transfusion 1994;34:1721

    CDC HIV/AIDS Surveillance Report 1997


  • Prevalence of donors in the window period1
    Prevalence of donors in the window period

    • 23,750 potential donors / 12 months =

      1,980 per month

    • X 3 months window period

    • = 5,940 per year

      • About 1 in 10,000 of the 65 million males of reproductive age -- 0.0091%

        • US Department of Census. Statistical Abstract of United States 1997. Tables 14,169,170



    Outcomes if all 80 000 inseminations were fresh1
    Outcomes if All 80,000 Inseminations Were Fresh

    Mean Fresh Frozen Difference

    Number of insemination cycles 3.83 4.33 -0.51

    Life years after age 30 44.597 43.601 -0.004

    Discounted QALYs 21.02 20.95 0.07


    Donor insemination micromorts from hiv 1
    Donor inseminationMicromorts from HIV-1

    Howard RA. Intn J Tech Assessment Health Care 1989;5:357


    Annual risks at home
    Annual Risks at Home

    Stallings & Paling. Obstet Gynecol 2001;98:345-9



    Ob gyn risks
    OB-Gyn Risks

    Stallings & Paling. Obstet Gynecol 2001;98:345



    Conclusions
    Conclusions

    • The risk of using fresh semen in donor insemination is quite small, in the range of risks we accept on a daily basis.

    • The reward, higher fecundity, is substantial.

    • Informed patients may reasonably accept the risk in order to get the reward.


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