HealthyNCT00326651
Home Usage of Conception Kit Instructions
An observational study of Healthy, run by Conceivex at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2006to May 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women who are actively trying to become pregnant
Who cannot join
- Women who are contraindicated for a pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dr. Charles Barker
Belding, Michigan, 48809
Dr. Dorsey Ligon
Grand Rapids, Michigan, 49503
About this study
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.
Read the detailed 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
- Conditions
- Healthy
- Keywords
- infertility, pregnancy, conception, conceive, conceiving, trying to conceive, get pregnant, conception kit, conception cap, fertility, Women who are actively trying to become pregnant
- Medical subject headings
- Infertility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startMay 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Time perspective
- Other
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Conceivex
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael G La Vean, Study director, Study Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326651
- Sponsor's protocol ID
- Conception Kit
- Status last verified
- Jan 2007
- First submitted
- 15 May 2006
- Last updated
- 1 Feb 2007
- Results posted
- No
Publications
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.
PubMed 9363712Coulson 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.
PubMed 8671164Subak 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.
PubMed 1615966Williams 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.
PubMed 7843434Corrigan 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.
PubMed 8027291Perino 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.
PubMed 3577597Corson SL, Batzer FR, Otis C, Fee D. The cervical cap for home artificial insemination. J Reprod Med. 1986 May;31(5):349-52.
PubMed 3746786Noci 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.
PubMed 3739559Bergquist 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.
PubMed 7155481Carruthers GB. Present-day management of male infertility. IPPF Med Bull. 1982 Jun;16(3):1-2.
PubMed 12338236Coucke W, Steeno O. Pregnancy rate after homologous insemination. Arch Androl. 1979;2(1):73-6. doi: 10.3109/01485017908987295.
PubMed 443924Segal S, Sherer M. The use of donor mucus and insemination for cervical factor. Int J Fertil. 1979;24(4):291-2.
PubMed 45104Jondet 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.
PubMed 1230473Meyer 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.
PubMed 8751744Drobnis 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.
PubMed 8283434
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Usage of Conception Kit Instructions
- ClinicalTrials.gov ID
- NCT00326651
- Acronym / sponsor ID
- Conception Kit
- Conditions
- Healthy
- Keywords
- infertility, pregnancy, conception, conceive, conceiving, trying to conceive, get pregnant, conception kit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- ConceivexIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- May 2007
- First posted
- 17 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Natural history
- Time perspective
- Other
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women who are actively trying to become pregnant
Key exclusion criteria (1 listed)
- Women who are contraindicated for a pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2007.
- Background: PubMed 9363712Flierman 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.
- Background: PubMed 8671164Coulson 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.
- Background: PubMed 1615966Subak 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.
- Background: PubMed 7843434Williams 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.
- Background: PubMed 8027291Corrigan 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.
- Background: PubMed 3577597Perino 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.
- Background: PubMed 3746786Corson SL, Batzer FR, Otis C, Fee D. The cervical cap for home artificial insemination. J Reprod Med. 1986 May;31(5):349-52.
- Background: PubMed 3739559Noci 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.
- Background: PubMed 7155481Bergquist 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.
- Background: PubMed 12338236Carruthers GB. Present-day management of male infertility. IPPF Med Bull. 1982 Jun;16(3):1-2.
- Background: PubMed 443924Coucke W, Steeno O. Pregnancy rate after homologous insemination. Arch Androl. 1979;2(1):73-6. doi: 10.3109/01485017908987295.
- Background: PubMed 45104Segal S, Sherer M. The use of donor mucus and insemination for cervical factor. Int J Fertil. 1979;24(4):291-2.
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G La Vean study director
Study Coordinator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Conceivex at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00326651, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2007.