InfertilityPCNCT02309073
PC Protocol: Preconceptional Screening
An observational study of Infertility, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Background: Despite considerable progress in the field of assisted reproductive technology (ART) maximum pregnancy rates generally do not exceed 30%. Furthermore, substantial differences in pregnancy rates are seen between women starting ART from seemingly similar clinical starting points and information on… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 1,500 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2013to Jan 2023
- How long will I take part?
- 3 Years
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In the present proposal we are aiming to include all normo-ovulatory women with a regular indication for ART or undergoing donorinsemination
Who may be able to join
- normo-ovulatory with a regular indication for ART or undergoing donorinsemination
Who cannot join
- Women with cycle disturbances
Trial locations and contacts
1 site in 1 country.
Bart Fauser, MD PhD contact
Frank Broekmans, MD PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht, 3508 GA
Bart Fauser, MD PhD, b.fauser@umcutrecht.nl
Bart Fauser, MD PhD
About this study
Official title: PC Protocol: Preconceptional Screening Part 2
Background: Despite considerable progress in the field of assisted reproductive technology (ART) maximum pregnancy rates generally do not exceed 30%. Furthermore, substantial differences in pregnancy rates are seen between women starting ART from seemingly similar clinical starting points and information on pregnancy/neonatal complications after ART is limited. For physicians and patients it would be extremely valuable if tools could be developed through which individualised chances of live birth and the development of pregnancy/neonatal complications can be calculated. In addition, there is increasing knowledge about health risks associated with subfertility and in particular with polycystic ovarian syndrome (PCOS) and premature ovarian failure (POF). An important void in research to date is the absence of a control group to check important new findings.
Objectives: The study protocol aims to form a cohort of normo-ovulatory women with a regular indication for ART which can aid the investigators principle lines of research:
Read more
- To study initial predictors of ovarian response to stimulation for IVF
- To study predictors of chances for live birth after repeated IVF cycles
- To assess the role for vascular health in the probabilities of success in ART treatment
- To study predictors for pregnancy and neonatal complications
- To form a control group for cycle disturbance studies
Study design: In this part of the protocol, serum and material for DNA analysis will be collected by asking patients to have 20 ml of blood drawn during a routine blood withdrawal. This blood will be stored in the Biobank of the UMC Utrecht at -80 C.
Study population: All women starting ART will be asked to participate. Women starting donorinsemination treatment will be asked to participate, from the viewpoint that they potentially will form a normal fertile control group.
Nature and extent of the burden and benefits associated with participation: There are no benefits or risks for the study patient as blood is withdrawn during a routine venapuncture and results will not be used for clinical practice.
Read the detailed description
The aim of this protocol is to collect serum and genotype from normo-ovulatory women with a regular indication for IVF/ICSI that can aid further research into the investigators principle lines of research which include improving performance ART treatment , limiting pregnancy complications, and improving offspring health.
- Conditions
- Infertility
- Medical subject headings
- Infertility
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 |
|---|---|---|
| women with a regular indication for ART | In the present proposal we are aiming to include all normo-ovulatory women with a regular indication for ART. | |
| women undergoing donor insemination treatment | potential normal fertile control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian response
number of oocytes, number of cycle cancellations, poor response, hyper response
Measured: 3 years
Secondary outcomes (2)
Prediction of pregnancy
prediction of clinical and ongoing pregnancy and live birth
Measured: 3 years
Adverse pregnancy outcome
Number of patients with adverse pregnancy outcome including pregnancy induced hypertension,pre-eclampsia, HELLP syndrome, diabetes, premature birth, intrauterine growth restriction
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bart CJM Fauser, UMC Utrecht
- Investigators
- Bart Fauser, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309073
- Sponsor's protocol ID
- 13-109
- Acronym
- PC
- Status last verified
- Oct 2021
- First submitted
- 6 Nov 2013
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Hamdine O, Eijkemans MJC, Lentjes EGW, Torrance HL, Macklon NS, Fauser BCJM, Broekmans FJ. Antimullerian hormone: prediction of cumulative live birth in gonadotropin-releasing hormone antagonist treatment for in vitro fertilization. Fertil Steril. 2015 Oct;104(4):891-898.e2. doi: 10.1016/j.fertnstert.2015.06.030. Epub 2015 Jul 18.
PubMed 26196233Hamdine O, Eijkemans MJ, Lentjes EW, Torrance HL, Macklon NS, Fauser BC, Broekmans FJ. Ovarian response prediction in GnRH antagonist treatment for IVF using anti-Mullerian hormone. Hum Reprod. 2015 Jan;30(1):170-8. doi: 10.1093/humrep/deu266. Epub 2014 Oct 29.
PubMed 25355590
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PC Protocol: Preconceptional Screening Part 2
- ClinicalTrials.gov ID
- NCT02309073
- Acronym / sponsor ID
- PC / 13-109
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 5 Dec 2014 (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.
Background: Despite considerable progress in the field of assisted reproductive technology (ART) maximum pregnancy rates generally do not exceed 30%. Furthermore, substantial differences in pregnancy rates are seen between women starting ART from seemingly similar clinical starting points and information on pregnancy/neonatal complications after ART is limited. For physicians and patients it would be extremely valuable if tools could be developed through which individualised chances of live birth and the development of pregnancy/neonatal complications can be calculated. In addition, there is increasing knowledge about health risks associated with subfertility and in particular with polycystic ovarian syndrome (PCOS) and premature ovarian failure (POF). An important void in research to date is the absence of a control group to check important new findings.
Objectives: The study protocol aims to form a cohort of normo-ovulatory women with a regular indication for ART which can aid the investigators principle lines of research:
- To study initial predictors of ovarian response to stimulation for IVF
- To study predictors of chances for live birth after repeated IVF cycles
- To assess the role for vascular health in the probabilities of success in ART treatment
- To study predictors for pregnancy and neonatal complications
- To form a control group for cycle disturbance studies
Study design: In this part of the protocol, serum and material for DNA analysis will be collected by asking patients to have 20 ml of blood drawn during a routine blood withdrawal. This blood will be stored in the Biobank of the UMC Utrecht at -80 C.
Study population: All women starting ART will be asked to participate. Women starting donorinsemination treatment will be asked to participate, from the viewpoint that they potentially will form a normal fertile control group.
Nature and extent of the burden and benefits associated with participation: There are no benefits or risks for the study patient as blood is withdrawn during a routine venapuncture and results will not be used for clinical practice.
Detailed description
The aim of this protocol is to collect serum and genotype from normo-ovulatory women with a regular indication for IVF/ICSI that can aid further research into the investigators principle lines of research which include improving performance ART treatment , limiting pregnancy complications, and improving offspring health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with a regular indication for ART | – | –In the present proposal we are aiming to include all normo-ovulatory women with a regular indication for ART. |
| women undergoing donor insemination treatment | – | –potential normal fertile control group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In the present proposal we are aiming to include all normo-ovulatory women with a regular indication for ART or undergoing donorinsemination
Key inclusion criteria (1 listed)
- normo-ovulatory with a regular indication for ART or undergoing donorinsemination
Key exclusion criteria (1 listed)
- Women with cycle disturbances
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
Ovarian response
Time frame: 3 years
number of oocytes, number of cycle cancellations, poor response, hyper response
2 secondary outcomes
Prediction of pregnancy
Time frame: 3 years
Adverse pregnancy outcome
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Derived from this study: PubMed 26196233Hamdine O, Eijkemans MJC, Lentjes EGW, Torrance HL, Macklon NS, Fauser BCJM, Broekmans FJ. Antimullerian hormone: prediction of cumulative live birth in gonadotropin-releasing hormone antagonist treatment for in vitro fertilization. Fertil Steril. 2015 Oct;104(4):891-898.e2. doi: 10.1016/j.fertnstert.2015.06.030. Epub 2015 Jul 18.
- Derived from this study: PubMed 25355590Hamdine O, Eijkemans MJ, Lentjes EW, Torrance HL, Macklon NS, Fauser BC, Broekmans FJ. Ovarian response prediction in GnRH antagonist treatment for IVF using anti-Mullerian hormone. Hum Reprod. 2015 Jan;30(1):170-8. doi: 10.1093/humrep/deu266. Epub 2014 Oct 29.
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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.
Bart Fauser, MD PhD contact
Frank Broekmans, MD PhD contact
Bart Fauser, MD PhD principal investigator
UMC Utrecht
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 Infertility, run by UMC Utrecht at 1 site in Netherlands.
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 20 Oct 2021. 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 Netherlands. 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?
Contact Bart Fauser, MD PhD (b.fauser@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian response (time frame: 3 years). 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 NCT02309073, which also lists 2 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 20 Oct 2021.