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Protocol - Mode of Conception - Medical Record Abstraction

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Protocol Name from Source:

Extremely Low Gestational Age Newborns (ELGAN) Chart Abstraction Form

Availability:

Publicly available

Description:

Information about the woman’s use of fertility treatments or fertility drugs or in vitro fertilization procedures is abstracted from the medical record.

Protocol:

1. Did the mother have any fertility therapy to get pregnant this time?

[ ] 0 No

[ ] 1 Yes

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.

[ ] 0 No

[ ] 1 Yes

2b. A fertility drug such as Clomiphene (Clomid) or Perganol

Enter 1 if the woman was treated with a fertility drug, 0 otherwise.

[ ] 0 No

[ ] 1 Yes

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.

[ ] 0 No

[ ] 1 Yes

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

[ ] 4 Fertinex

[ ] 5 Pregnyl, Profasi, Novarelle, Ovidrel

[ ] 6 Lupron

[ ] 7 Progesterone, Utrogestan, Prometrium, Crinone

[ ] 8 Other

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.

[ ] 1 IVF

[ ] 2 IVF + assisted hatching

[ ] 3 GIFT

[ ] 4 ZIFT

[ ] 5 ICSI

[ ] 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.

Equipment Needs

None

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Adolescent, Adult, Pregnancy

Specific Instructions:

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.

Research Domain Information

Release Date:

January 31, 2017

Definition

Questions about whether medical intervention of any kind was needed to achieve pregnancy.

Purpose

Information about natural or assisted conception (i.e., infertility treatments or reproductive technologies) is essential to determine fertility status.

Selection Rationale

This information was abstracted from medical records for the Extremely Low Gestational Age Newborns (ELGAN) project, a major study of low gestational age newborns.

Language

English

Standards

StandardNameIDSource
Common Data Elements (CDE)Chart Abstraction Pregnancy Conception Mode Assessment Text5633918CDE Browser

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source

Extremely Low Gestational Age Newborns (ELGAN) Chart Abstraction Form, 2002 version, Items 28-34

General References

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.

Protocol ID:

241202

Variables:

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