NCT00326651

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2006

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

February 1, 2007

Status Verified

January 1, 2007

First QC Date

May 15, 2006

Last Update Submit

January 31, 2007

Conditions

Healthy

Keywords

infertilitypregnancyconceptionconceiveconceivingtrying to conceiveget pregnantconception kitconception capfertilityWomen who are actively trying to become pregnant

Eligibility Criteria

Age16 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women who are actively trying to become pregnant

You may not qualify if:

  • Women who are contraindicated for a pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr. Charles Barker

Belding, Michigan, 48809, United States

Location

Dr. Dorsey Ligon

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (22)

  • 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. doi: 10.1093/humrep/12.9.1945.

    PMID: 9363712BACKGROUND

  • 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. doi: 10.1093/oxfordjournals.humrep.a019044.

    PMID: 8671164BACKGROUND

  • 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. doi: 10.1016/0002-9378(92)91548-o.

    PMID: 1615966BACKGROUND

  • 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. doi: 10.1016/s0015-0282(16)57358-0.

    PMID: 7843434BACKGROUND

  • 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. doi: 10.1093/oxfordjournals.humrep.a138502.

    PMID: 8027291BACKGROUND

  • 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.

    PMID: 3577597BACKGROUND

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

    PMID: 3746786BACKGROUND

  • 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.

    PMID: 3739559BACKGROUND

  • 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.

    PMID: 7155481BACKGROUND

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

    PMID: 12338236BACKGROUND

  • Coucke W, Steeno O. Pregnancy rate after homologous insemination. Arch Androl. 1979;2(1):73-6. doi: 10.3109/01485017908987295.

    PMID: 443924BACKGROUND

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

    PMID: 45104BACKGROUND

  • 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.

    PMID: 1230473BACKGROUND

  • 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. doi: 10.1016/s0015-0282(16)58515-x.

    PMID: 8751744BACKGROUND

  • 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. doi: 10.1530/jrf.0.0990159.

    PMID: 8283434BACKGROUND

  • 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. doi: 10.1093/oxfordjournals.humrep.a138567.

    PMID: 8046019BACKGROUND

  • 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. doi: 10.1016/s0015-0282(16)46936-0.

    PMID: 6832404BACKGROUND

  • Scott JZ, Nakamura RM, Mutch J, Davajan V. The cervical factor in infertility: diagnosis and treatment. Fertil Steril. 1977 Dec;28(12):1289-94. doi: 10.1016/s0015-0282(16)42971-7.

    PMID: 590536BACKGROUND

  • 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. doi: 10.1016/0002-9378(81)90105-8.

    PMID: 7234912BACKGROUND

  • O'Brien P, Vandekerckhove P. Intra-uterine versus cervical insemination of donor sperm for subfertility. Cochrane Database Syst Rev. 2000;(2):CD000317. doi: 10.1002/14651858.CD000317.

    PMID: 10796709BACKGROUND

  • Mahony MC. Evaluation of the effect of a cervical cap device on sperm functional characteristics in vitro. Andrologia. 2001 Jul;33(4):207-13. doi: 10.1046/j.1439-0272.2001.00426.x.

    PMID: 11472332RESULT

  • Adamson GD, Subak LL, Boltz NL, McNulty MA. Failure of intrauterine insemination in a refractory infertility population. Fertil Steril. 1991 Aug;56(2):361-3. doi: 10.1016/s0015-0282(16)54502-6.

    PMID: 2070868RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Michael G La Vean

    Study Coordinator

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
OTHER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

May 1, 2006

Study Completion

May 1, 2007

Last Updated

February 1, 2007

Record last verified: 2007-01

Locations

US(2)