Lady-Comp, Baby-Comp and Pearly Medical Studies

Here are a list of clinical tests and studies into the Valley Electronics range of cycle computers.

Many thanks to the Valley Electronics Research Department for supplying this information.

Clinical Tests and Reports on BABY-COMP® and LADY-COMP®

1. Medical Product, Directive 93/42/EEC, January, 2009

Quality Management, Medical Device, Directive 93/42/EEC

Quality Management, Voluntary participation in regular monitoring EN ISO13485:2003 + AC:2007.

2. Medical Evaluation, Dr. Andreas Marx – ClevaMed, Sept. 20th, 2007

EG-Instruction 93/42 EWG und MEDDEV.2.7.1

‘very high degree in Method-Security, which clearly stands out from competitive devices’.

3. Certification EMV EN60601-1-2

March 12th, 2007 LADY-COMP®

March 19th, 2007 BABY-COMP®

July 10th, 2007 pearly®

4. Certification of Production

ISO9001: 2000 / ISO14001: 2004

Environmental Assessment Bavaria, December 16th, 2005

5. Congresso della Societa Italiana della Contraccezione, June 16-18th, 2005 Lettura BABY-COMP®

Dr. Hubertus Rechberg: Contraception and Baby-planning with LADY-COMP® and BABY-COMP®

6. FDA, January 2005 Office of Device Evaluation (ODE)

as an aid in ovulation prediction

7. New York Observer, Juni 25th, 2004

Sheelah Kolhatkar: Orgasmatron shows up: High-Tech-Rhythm

8. Advances in Contraception 1998; 14: 97-108

Prof. Freundl, Frank-Herrmann, Prof. Godehardt, Klemm, Bachhofer

Trial of contraceptive effectiveness of LADY-COMP® / BABY-COMP®

Results: User Pearl-Index 0.7.

9. Düsseldorf 1998, Dissertation Bachhofer, Prof. Freundl, Frank-Herrmann, Prof. Godehardt, Klemm

686 women in more than two years use = Pearl-Index 0.7.

Field study in Switzerland, Germany and Mexico.

10. Sassari 1997, Prof. S. Dessole, Fadda, Rosas, Scapinelli, Inaudi, Ambrosini

Test on women sterille for 3 – 8 years. BABY-COMP® compared with clinical testing.

Results: 100% match on luteal deficiency, anovulatiory cycles and pregnancies.

Clinical found 86% Ovulation’s, BABY-COMP® 80%. (Original in English)

11. Birmingham 1997, Prof. Freundl

Test of 686 women over 24 month and 12.213 Cycles. Results: see below 8.

12. Erlangen 1994, Prof. Wildt

Clinical testing and comparison with BABY-COMP®.

Results: perfect match between clinical findings and fertility indications of BABY-COMP®.

13. Fertilität 1992, Nr. 8, Pages 66-67

Clinical testing compared with BABY-COMP® fertility indications.

Results: in no case BABY-COMP® missed the beginning of fertile time,

cycle disturbances were detected and treated right.

14. Amsterdam 1992, Prof. Martinez, v. Hoof, Schoute, v.d. Meer

Clinical Test and research on Hormone- and Temperature shifts.

Results: They do correlate and there is BABY-COMP® that might improve reliability,

acceptability and application of BBT in fertility investigation. (Original in English)

15. Barcelona Congress 1992, Prof. Freundl, Bauer, Bremme, Döring, Frank-Herrmann

Test on fertile women. Compared with clinical testing.

Definition: 6 Days are fertile.

Results: LADY-COMP® found temperature shift in each cycle. Number of fertile days 11.1 +/- 3.

Length of cycles 25-35. No pregnancy on ‘green’ days. (Original in English)

16. Rhodos 1988, Prof. Freundl, Frank-Herrmann, Toncaboni

a) test on preciseness of temperature readings

Results: Temperature readings highly precise p2 0.01.

b) test on prevention compared with clinical testiness.

Results: no unwanted Pregnancies on ‘green’ days.

c) test on planing.

Results: 2 out of 5 conceived already during the test. (Original in English)

The original document can be downloaded here.