Home Usage of Conception Kit Instructions

Healthy Clinical Trial

Official title:

Home Usage of Conception Kit Instructions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00326651
• Other study ID #: Conception Kit
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 15, 2006
• Last updated: January 31, 2007
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: January 2007
• Source: Conceivex
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Patients will use the Conception Kit in their home and fill out a 22 question questionnaire in order to demonstrate their knowledge of the method of usage as described in the instructions and on the website: www.conceptionkit.com.

Description:

Patients will be given a Conception Kit and take the Kit home and read the instructions and if needed consult the website. The patient will then complete a 22 question questionnaire in order to demonstrate their knowledge of the method of use.

All Components have 510K clearance. This study is a validation of the instructions for use (IFU) only.

OPK Class I Device 21CFR 862.1485, Conception Cap K993953, Pregnancy Test Kit K974059, Semen Collection Device K902936 (21CFR 884.5300),

Conception Kit has CE Marked by GMED. (Certificate 2037)

Conceivex is an ISO 13485: 2003 company

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women who are actively trying to become pregnant

Exclusion Criteria:

• Women who are contraindicated for a pregnancy

Study Design

Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
United States	Dr. Charles Barker	Belding	Michigan
United States	Dr. Dorsey Ligon	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Conceivex

Country where clinical trial is conducted

United States, 

References & Publications (22)

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Bergquist CA, Rock JA, Miller J, Guzick DS, Wentz AC, Jones GS. Artificial insemination with fresh donor semen using the cervical cap technique: a review of 278 cases. Obstet Gynecol. 1982 Aug;60(2):195-9. — View Citation

Carruthers GB. Present-day management of male infertility. IPPF Med Bull. 1982 Jun;16(3):1-2. — View Citation

Corrigan E, McLaughlin EA, Coulson C, Ford WC, Hull MG. The effect of halving the standard dose of cryopreserved semen for donor insemination: a controlled study of conception rates. Hum Reprod. 1994 Feb;9(2):330-3. — View Citation

Corson SL, Batzer FR, Otis C, Fee D. The cervical cap for home artificial insemination. J Reprod Med. 1986 May;31(5):349-52. — View Citation

Coucke W, Steeno O. Pregnancy rate after homologous insemination. Arch Androl. 1979;2(1):73-6. — View Citation

Coulson C, McLaughlin EA, Harris S, Ford WC, Hull MG. Randomized controlled trial of cervical cap with intracervical reservoir versus standard intracervical injection to inseminate cryopreserved donor semen. Hum Reprod. 1996 Jan;11(1):84-7. — View Citation

Depypere HT, Gordts S, Campo R, Comhaire F. Methods to increase the success rate of artificial insemination with donor semen. Hum Reprod. 1994 Apr;9(4):661-3. — View Citation

Diamond MP, Christianson C, Daniell JF, Wentz AC. Pregnancy following use of the cervical cup for home artificial insemination utilizing homologous semen. Fertil Steril. 1983 Apr;39(4):480-4. — View Citation

Drobnis EZ, Clisham PR, Brazil CK, Wisner LW, Zhong CQ, Overstreet JW. Detection of altered acrosomal physiology of cryopreserved human spermatozoa after sperm residence in the female reproductive tract. J Reprod Fertil. 1993 Sep;99(1):159-65. — View Citation

Flierman PA, Hogerzeil HV, Hemrika DJ. A prospective, randomized, cross-over comparison of two methods of artificial insemination by donor on the incidence of conception: intracervical insemination by straw versus cervical cap. Hum Reprod. 1997 Sep;12(9):1945-8. — View Citation

Hanson FW, Overstreet JW. The interaction of human spermatozoa with cervical mucus in vivo. Am J Obstet Gynecol. 1981 May 15;140(2):173-8. — View Citation

Jondet D, Millet D, Netter A. [Adaptation of a cervical cap for human artificial insemination]. J Gynecol Obstet Biol Reprod (Paris). 1975 Jan-Feb;4(1):141-4. French. — View Citation

Mahony MC. Evaluation of the effect of a cervical cap device on sperm functional characteristics in vitro. Andrologia. 2001 Jul;33(4):207-13. — View Citation

Meyer WR, Smith PM, Clark MR, Cusmano LL, Fritz MA. Therapeutic cup insemination with cryopreserved donor sperm: prognostic value of cervical mucus score at insemination and the number of motile sperm in mucus at 24 hours. Fertil Steril. 1996 Sep;66(3):435-9. — View Citation

Noci I, Chelo E, Scarselli G, Messori A. Cervical cap homologous artificial insemination (AIH): the University of Florence experience. Acta Eur Fertil. 1986 Mar-Apr;17(2):133-7. — View Citation

O'Brien P, Vandekerckhove P. Intra-uterine versus cervical insemination of donor sperm for subfertility. Cochrane Database Syst Rev. 2000;(2):CD000317. Review. Update in: Cochrane Database Syst Rev. 1998;(4):CD000317. Cochrane Database Syst Rev. 2008;(2):CD000317. — View Citation

Perino A, Cimino C, Catinella E, Barba G, Cittadini E. In vitro sperm capacitation and intrauterine insemination (IVC-Insem): a simple technique for the treatment of refractory infertility unrelated to female organic pelvic disease. Clinical results and immunological effects: a preliminary report. Acta Eur Fertil. 1986 Sep-Oct;17(5):325-31. — View Citation

Scott JZ, Nakamura RM, Mutch J, Davajan V. The cervical factor in infertility: diagnosis and treatment. Fertil Steril. 1977 Dec;28(12):1289-94. — View Citation

Segal S, Sherer M. The use of donor mucus and insemination for cervical factor. Int J Fertil. 1979;24(4):291-2. — View Citation

Subak LL, Adamson GD, Boltz NL. Therapeutic donor insemination: a prospective randomized trial of fresh versus frozen sperm. Am J Obstet Gynecol. 1992 Jun;166(6 Pt 1):1597-604; discussion 1604-6. — View Citation

Williams DB, Moley KH, Cholewa C, Odem RR, Willand J, Gast MJ. Does intrauterine insemination offer an advantage to cervical cap insemination in a donor insemination program? Fertil Steril. 1995 Feb;63(2):295-8. — View Citation

* Note: There are 22 references in all — Click here to view all references