Splitting of Ovarianstimulation and EmbryotransferNCT00795041
Temporally Splitting Ovarian Stimulation and Embryo Transfer
An observational study of Splitting of Ovarianstimulation and Embryotransfer, run by University of Luebeck at 1 site in Germany.
Trial summary
The purpose of this study is to explore the concept of temporally splitting ovarian stimulation and embryo transfer. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Splitting of Ovarianstimulation and Embryotransfer
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Sep 2010
- 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 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Study population: women with indication for ART with ICSI or IVF
Who may be able to join
- Indication for IVF/ICSI
- Age 18-36 years
- <= three earlier unsuccessful IVF/ICSI treatments with embryo transfer
- BMI 20-30
- Regular cycle with ovulation (28-35 days)
- Progesterone >7ng/ml at the beginning of stimulation
- Informed consents
Who cannot join
- PCOS (polycystic ovarian syndrome
- Endometrioses >= grade 3
- Known poor response syndrome
- History of ovariectomy
- Severe endocrinopathie
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Schleswig Holstein, Campus Luebeck, Department of Obstetrics and Gynecology
Lübeck, Schleswig-Holstein, 23538
About this study
The purpose of this study is to explore the concept of temporally splitting ovarian stimulation and embryo transfer.
- Keywords
- vitrification, ovarian stimulation, reproductive medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 10 women with indication for ART with ICSI or IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Measured: November 2008- May 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Splitting of Ovarianstimulation and EmbryotransferStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Investigators
- Georg Griesinger, PD MD, Principal investigator, University of Schleswig-Holstein, Campus Luebeck, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795041
- Sponsor's protocol ID
- TS1
- Status last verified
- Nov 2008
- First submitted
- 20 Nov 2008
- Last updated
- 18 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Buendgen NK, Schultze-Mosgau A, Cordes T, Diedrich K, Griesinger G. Initiation of ovarian stimulation independent of the menstrual cycle: a case-control study. Arch Gynecol Obstet. 2013 Oct;288(4):901-4. doi: 10.1007/s00404-013-2794-z. Epub 2013 Apr 3.
PubMed 23545834
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporally Splitting Ovarian Stimulation and Embryo Transfer
- ClinicalTrials.gov ID
- NCT00795041
- Acronym / sponsor ID
- TS1
- Keywords
- vitrification, ovarian stimulation, reproductive medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Nov 2008 (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.
The purpose of this study is to explore the concept of temporally splitting ovarian stimulation and embryo transfer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –10 women with indication for ART with ICSI or IVF |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women with indication for ART with ICSI or IVF
Key inclusion criteria (7 listed)
- Indication for IVF/ICSI
- Age 18-36 years
- <= three earlier unsuccessful IVF/ICSI treatments with embryo transfer
- BMI 20-30
- Regular cycle with ovulation (28-35 days)
Key exclusion criteria (5 listed)
- PCOS (polycystic ovarian syndrome
- Endometrioses >= grade 3
- Known poor response syndrome
- History of ovariectomy
- Severe endocrinopathie
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
Ongoing pregnancy rate
Time frame: November 2008- May 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2010.
- Derived from this study: PubMed 23545834Buendgen NK, Schultze-Mosgau A, Cordes T, Diedrich K, Griesinger G. Initiation of ovarian stimulation independent of the menstrual cycle: a case-control study. Arch Gynecol Obstet. 2013 Oct;288(4):901-4. doi: 10.1007/s00404-013-2794-z. Epub 2013 Apr 3.
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.
Georg Griesinger, PD MD principal investigator
University of Schleswig-Holstein, Campus Luebeck, Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Splitting of Ovarianstimulation and Embryotransfer, run by University of Luebeck at 1 site in Germany.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 18 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: November 2008- May 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00795041, which also lists 1 linked publication.
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 18 Oct 2010.