Protocol - Mode of Conception - Medical Record Abstraction
Information about the woman’s use of fertility treatments or fertility drugs or in vitro fertilization procedures is abstracted from the medical record.
The fertility clinic and obstetric medical records provide objective information about medical interventions to achieve pregnancy. Information from the medical record complements the information obtained from the Mode of Conception - Interview protocol and ideally, both modes of administration are used.
1. Did the mother have any fertility therapy to get pregnant this time?
If she did NOT have any fertility treatment, then proceed to END.
2. If YES: Treatment with:
2a. Intrauterine insemination (IUI).
Enter 1 if the woman had intrauterine insemination, 0 otherwise.
2b. A fertility drug such as Clomiphene (Clomid) or Perganol
Enter 1 if the woman was treated with a fertility drug, 0 otherwise.
2c. A procedure such as IVF or ICSI
Enter 1 if the woman had a fertility procedure, 0 otherwise.
Note that the mother may have more than one of the fertility therapies.
3. If Q2b = YES: What drug(s)?
Please identify all fertility drug types here:
1[ ]Clomid, Serophene (Clomiphene)
2[ ]Gonal-F, Follistim
3[ ]Pergonal, Repronex, Humogon
5[ ]Pregnyl, Profasi, Novarelle, Ovidrel
7[ ]Progesterone, Utrogestan, Prometrium, Crinone
4. If the mother did NOT have a fertility procedure, skip the remaining questions. If Q2c = YES: What fertility procedure was used?
Please identify the fertility procedure.
2[ ]IVF + assisted hatching
6[ ]ICSI + assisted hatching
5. Please enter the transfer date (date embryos transferred to the mother’s uterus or fallopian tube) as listed in the chart.
Transfer date _____________ (mm/dd/yyyy)
6. Please enter the retrieval date (date eggs were harvested from the mother) as listed in the chart.
Retrieval date ________________ (mm/dd/yyyy)
7. Number of eggs retrieved _____________
Please enter the number of eggs retrieved as listed in the chart.
Personnel and Training Required
Personnel should be trained in medical record abstraction.
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Medical record abstraction
Adolescent, Adult, Pregnancy
This information was abstracted from medical records for the Extremely Low Gestational Age Newborns (ELGAN) project, a major study of low gestational age newborns.
|caDSR Common Data Elements (CDE)||Chart Abstraction Pregnancy Conception Mode Assessment Text||5633918||CDE Browser|
|Human Phenotype Ontology||Infertility||HP:0000789||HPO|
Process and Review
Protocol Name from Source
Extremely Low Gestational Age Newborns (ELGAN) Chart Abstraction Form
Extremely Low Gestational Age Newborns (ELGAN) Chart Abstraction Form, 2002 version, Items 28-34
O’Shea, T. M., Allred, E. N, Dammann, O., Hirtz, D., Kuban, K. C. K., Paneth, N., Leviton, A., for the ELGAN study Investigators. (2009). The ELGAN Study of brain and related disorders in extremely low gestational age newborns. Early Human Devel, 85, 719-25.
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX241202070000||Number of eggs retrieved _____________||N/A|
|PX241202060000||Please enter the retrieval date (date eggs more||N/A|
|PX241202050000||Please enter the transfer date (date embryos more||N/A|
|PX241202020200||A fertility drug such as Clomiphene (Clomid) more||N/A|
|PX241202030000||If Q2b = YES: What drug(s)? Please identify more||N/A|
|PX241202020300||A procedure such as IVF or ICSI. Enter 1 if more||N/A|
|PX241202040000||If Q2c = YES: What fertility procedure was more||N/A|
|PX241202020100||Enter 1 if the woman had intrauterine more||N/A|
|PX241202010000||Did the mother have any fertility therapy to more||N/A|
Mode of Conception
January 31, 2017
Questions about whether medical intervention of any kind was needed to achieve pregnancy.
Information about natural or assisted conception (i.e., infertility treatments or reproductive technologies) is essential to determine fertility status.
Pregnancy, conception, fertility, infertility treatment, Extremely Low Gestational Age Newborns, ELGAN, Pregnancy Risk Assessment Monitoring System, PRAMS, Centers for Disease Control and Prevention, CDC