InfertilityNCT04142190
Corifollitropin Alfa and Embryo Morphokinetics
An observational study of Infertility, run by Kinderwunsch Institut GmbH at 1 site in Austria.
Trial summary
The study evaluates the influence of corifollitropin alfa (Elonva) on embryo morphokinetics and fertility treatment outcome in comparison to a control group stimulated with Follitropin beta (Puregon). Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- ELONVA and PUREGON
- Type of treatment
- Injection or infusion
- How many people
- 1,351 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2013to Dec 2018
- 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 42 years
- Women only
- Adult
Study population: Women suffering from infertility
Who may be able to join
- Age: 18-42
- BMI: 19-29.9
- Primary or secondary infertility
- Ovarian stimulation with Elonva/Puregon
- Embryos cultured in embryoscope
Who cannot join
- unexpected low response
- genetic testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Corifollitropin Alfa (Elonva) on Embryo Morphokinetics and Fertility Treatment Outcome
The study evaluates the influence of corifollitropin alfa (Elonva) on embryo morphokinetics and fertility treatment outcome in comparison to a control group stimulated with Follitropin beta (Puregon).
Read the detailed description
Morphokinetic parameters of embryo development have been intensively investigated. However, little attention has been paid to the influence of ovarian stimulation on morphokinetic parameters. Gryshenko et al. found a significant difference in the fourth cell division time (t5) of embryos obtained after controlled ovarian hyperstimulation in long GnRH agonists and GnRH antagonist protocols. Furthermore, higher gonadotropin doses were found to slow down the development of the embryos.
Hence, the aim of this study is to investigate the influence of corifollitropin alfa (Elonva) on embryo morphokinetics and fertility treatment outcome in comparison to a control group stimulated with Follitropin beta (Puregon). The investigators hypothesize that there are differences in morphokinetic behavior of embryos within the different stimulation protocols.
A total of 742 embryos from 215 different patients suffering from infertility undergoing ovarian stimulation with Elonva and a total of 5148 embryos from 1136 patients undergoing ovarian stimulation with Puregon will be retrospectively analyzed. To exclude environmental factors the evaluation will distinguish between embryos cultured under 21% oxygen and embryos with reduced oxygen conditions (5% oxygen) in the embryoscope. Groups will be age and BMI matched.
All women included in the study underwent GnRH (Gonadotropin-releasing hormone) antagonist protocol controlled ovarian hyperstimulation. Patients received recombinant human follicle-stimulating hormone (Elonva; MSD Sharp \&Dohme GMBH, Puregon; MSD Sharp \& Dohme GMBH). ELONVA was administered for 7 days with subsequent administration of Puregon (MSD Sharp \& Dohme GMBH) in case of further need of stimulation. Puregon was administered for 8-10 days with dosage adaption according to age, weight, serum anti-mullerian hormone (sAMH) concentration, and hormonal status. Trans-vaginal sonography was performed after 5 days of stimulation, followed by every second day until the day of oocyte retrieval. Ultrasonographical measurement was performed using a RIC 5-9-D 4D intravaginal probe of a GE Voluson E8 BT09 ultrasound machine (both from GE Healthcare Austria GmbH). GnRH antagonist (Cetrotide, Merck KGaA) was injected to avoid premature ovulation. Triggering was initiated 35 h before oocyte retrieval, administered with 5000-10,000 IU human chorionic gonadotropin (hCG) subcutaneously (Pregnyl, N.V. Organon), with dosage adaption according to body weight of the patient.
Follicles larger than 10 mm in diameter were aspirated under sedation (Propofol, Fresenius Kabi Austria GmbH; Rapifen, Janssen-Cilag Pharma GmbH) and transvaginal ultrasound guidance (GE Healthcare Austria GmbH). Follicular fluid (FF) were examined for oocytes under constant conditions of 37 °C in an IVF workstation L24E with heating stage (K-SYSTEMS Kivex Biotec A/S). Intracytoplasmic sperm injection (ICSI) was performed on all metaphase II (MII) oocytes 4-5h after oocyte retrieval according to our standard operating procedure in both groups of patients.
After oocyte retrieval and fertilization, oocytes were cultivated in universal culture medium (Gynemed Medizinprodukte GmbH \& Co. KG, Germany). After 14-16 h, fertilization check was performed. All normal fertilized embryos with two pronuclei (PN) were then cultured using Embryoslide dishes in Embryoscope® time-lapse incubator (both Vitrolife AB, Sweden). With the built-in camera and microscope, images of the developing embryo were taken every 15 min in seven different layers. Definition of morphokinetic parameters was performed according to the criteria proposed by Ciray et al. and was analyzed with software developed for time-lapse image analysis (Embryoviewer® software; Vitrolife AB, Sweden).
- Conditions
- Infertility
- Being tested
- ELONVA, PUREGON
- Keywords
- follicle-stimulating hormone, embryo morphokinetics, reproductive medicine
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELONVADrug
Elonva is a solution for injection that contains the active substance corifollitropin alfa. It is available as a pre-filled syringe (100 and 150 micrograms).Elonva is used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries.
PUREGONDrug
Puregon contains the active substance follitropin beta. fertilisation). Puregon is administered to stimulate the ovaries to produce more than one egg at a time
| Study group | Role | What they receive |
|---|---|---|
| ELONVA | Patients stimulated with Elonva Receives: Drug: ELONVA | |
| PUREGON | Patients stimulated with Puregon Receives: Drug: PUREGON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of pronuclei disappearance
Time of pronuclei disappearance in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Measured: 16-18 hours after fertilization
Two discrete cells
The first observation of two discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Measured: 26-28 hours after fertilization
Three discrete cells
The first observation of three discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Measured: 28-44 hours after fertilization
Four discrete cells
The first observation of four discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Measured: 44-45 hours after fertilization
Five discrete cells
The first observation of five discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Measured: 44-68 hours after fertilization
Six discrete cells
The first observation of six discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Measured: 44-68 hours after fertilization
Seven discrete cells
The first observation of seven discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Measured: 44-68 hours after fertilization
Eight discrete cells
The first observation of eight discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Measured: 68-69 hours after fertilization
Nine discrete cells
The first observation of nine discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Measured: 69-92 hours after fertilization
Morula stage
End of the compaction process; when observable compaction is complete in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Measured: 92 hours after fertilization
Secondary outcomes (8)
Number of oocytes retrieved
The influence of ELONVA versus PUREGON on the number of oocytes retrieved will be assessed.
Measured: Number of oocytes retrieved will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)
Stage of oocyte development
The influence of ELONVA versus PUREGON on the maturity stage of oocytes (germinal vesicle, metaphase I (MI) or MII phase) retrieved will be assessed.
Measured: Stage of oocytes retrieved will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)
Fertilized oocytes
The influence of ELONVA versus PUREGON on the number of fertilized oocytes will be assessed.
Measured: Number of fertilized oocytes will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)
Embryo grading
The influence of ELONVA versus PUREGON on embryo grading (Istanbul consensus criteria) will be assessed. The grading consists of assessment of cell number, fragmentation, multinucleation, cell size, cytoplasmic granularity, membrane appearance, and the presence of vacuoles).
Measured: The quality of embryos will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)
Biochemical pregnancy (measurement of beta hCG)
The influence of Elonva versus Puregon on the number of biochemical pregnancies will be assessed.
Measured: Biochemical pregnancies will be evaluated after successful implantation (1 week after embryo transfer)
Life birth
The influence of Elonva versus Puregon on the number of life births will be assessed.
Measured: Life births will be evaluated after successful pregnancy (9 moths after embryo transfer)
Weight (kilograms)
The influence of Elonva versus Puregon on the weight of the newborn will be assessed.
Measured: Weight of the newborn will be evaluated after birth (9 moths after embryo transfer)
Height (centimeters)
The influence of Elonva versus Puregon on the height of the newborn will be assessed.
Measured: Height of the newborn will be evaluated after birth (9 moths after embryo transfer)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study startJan 2013
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinderwunsch Institut GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Michael Schenk, Dr., Principal investigator, Das Kinderwunsch Institut Schenkg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142190
- Sponsor's protocol ID
- FRED001
- Status last verified
- Oct 2019
- First submitted
- 14 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It has to be clarified with MERCK if sharing of data is applicable for this project.
Publications
Gryshchenko MG, Pravdyuk AI, Parashchyuk VY. Analysis of factors influencing morphokinetic characteristics of embryos in ART cycles. Gynecol Endocrinol. 2014 Oct;30 Suppl 1:6-8. doi: 10.3109/09513590.2014.945763.
PubMed 25200818Wissing ML, Bjerge MR, Olesen AI, Hoest T, Mikkelsen AL. Impact of PCOS on early embryo cleavage kinetics. Reprod Biomed Online. 2014 Apr;28(4):508-14. doi: 10.1016/j.rbmo.2013.11.017. Epub 2013 Dec 17.
PubMed 24581983Chawla M, Fakih M, Shunnar A, Bayram A, Hellani A, Perumal V, Divakaran J, Budak E. Morphokinetic analysis of cleavage stage embryos and its relationship to aneuploidy in a retrospective time-lapse imaging study. J Assist Reprod Genet. 2015 Jan;32(1):69-75. doi: 10.1007/s10815-014-0372-3. Epub 2014 Nov 14.
PubMed 25395178Armstrong S, Vail A, Mastenbroek S, Jordan V, Farquhar C. Time-lapse in the IVF-lab: how should we assess potential benefit? Hum Reprod. 2015 Jan;30(1):3-8. doi: 10.1093/humrep/deu250. Epub 2014 Oct 14.
PubMed 25316446Milewski R, Kuc P, Kuczynska A, Stankiewicz B, Lukaszuk K, Kuczynski W. A predictive model for blastocyst formation based on morphokinetic parameters in time-lapse monitoring of embryo development. J Assist Reprod Genet. 2015 Apr;32(4):571-9. doi: 10.1007/s10815-015-0440-3. Epub 2015 Feb 18.
PubMed 25690157VerMilyea MD, Tan L, Anthony JT, Conaghan J, Ivani K, Gvakharia M, Boostanfar R, Baker VL, Suraj V, Chen AA, Mainigi M, Coutifaris C, Shen S. Computer-automated time-lapse analysis results correlate with embryo implantation and clinical pregnancy: a blinded, multi-centre study. Reprod Biomed Online. 2014 Dec;29(6):729-36. doi: 10.1016/j.rbmo.2014.09.005. Epub 2014 Sep 21.
PubMed 25444507
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Corifollitropin Alfa (Elonva) on Embryo Morphokinetics and Fertility Treatment Outcome
- ClinicalTrials.gov ID
- NCT04142190
- Acronym / sponsor ID
- FRED001
- Conditions
- Infertility
- Keywords
- follicle-stimulating hormone, embryo morphokinetics, reproductive medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,351 participants (actual)
- Lead sponsor
- Kinderwunsch Institut GmbHUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 29 Oct 2019 (actual)
- 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 study evaluates the influence of corifollitropin alfa (Elonva) on embryo morphokinetics and fertility treatment outcome in comparison to a control group stimulated with Follitropin beta (Puregon).
Detailed description
Morphokinetic parameters of embryo development have been intensively investigated. However, little attention has been paid to the influence of ovarian stimulation on morphokinetic parameters. Gryshenko et al. found a significant difference in the fourth cell division time (t5) of embryos obtained after controlled ovarian hyperstimulation in long GnRH agonists and GnRH antagonist protocols. Furthermore, higher gonadotropin doses were found to slow down the development of the embryos.
Hence, the aim of this study is to investigate the influence of corifollitropin alfa (Elonva) on embryo morphokinetics and fertility treatment outcome in comparison to a control group stimulated with Follitropin beta (Puregon). The investigators hypothesize that there are differences in morphokinetic behavior of embryos within the different stimulation protocols.
A total of 742 embryos from 215 different patients suffering from infertility undergoing ovarian stimulation with Elonva and a total of 5148 embryos from 1136 patients undergoing ovarian stimulation with Puregon will be retrospectively analyzed. To exclude environmental factors the evaluation will distinguish between embryos cultured under 21% oxygen and embryos with reduced oxygen conditions (5% oxygen) in the embryoscope. Groups will be age and BMI matched.
All women included in the study underwent GnRH (Gonadotropin-releasing hormone) antagonist protocol controlled ovarian hyperstimulation. Patients received recombinant human follicle-stimulating hormone (Elonva; MSD Sharp \&Dohme GMBH, Puregon; MSD Sharp \& Dohme GMBH). ELONVA was administered for 7 days with subsequent administration of Puregon (MSD Sharp \& Dohme GMBH) in case of further need of stimulation. Puregon was administered for 8-10 days with dosage adaption according to age, weight, serum anti-mullerian hormone (sAMH) concentration, and hormonal status. Trans-vaginal sonography was performed after 5 days of stimulation, followed by every second day until the day of oocyte retrieval. Ultrasonographical measurement was performed using a RIC 5-9-D 4D intravaginal probe of a GE Voluson E8 BT09 ultrasound machine (both from GE Healthcare Austria GmbH). GnRH antagonist (Cetrotide, Merck KGaA) was injected to avoid premature ovulation. Triggering was initiated 35 h before oocyte retrieval, administered with 5000-10,000 IU human chorionic gonadotropin (hCG) subcutaneously (Pregnyl, N.V. Organon), with dosage adaption according to body weight of the patient.
Follicles larger than 10 mm in diameter were aspirated under sedation (Propofol, Fresenius Kabi Austria GmbH; Rapifen, Janssen-Cilag Pharma GmbH) and transvaginal ultrasound guidance (GE Healthcare Austria GmbH). Follicular fluid (FF) were examined for oocytes under constant conditions of 37 °C in an IVF workstation L24E with heating stage (K-SYSTEMS Kivex Biotec A/S). Intracytoplasmic sperm injection (ICSI) was performed on all metaphase II (MII) oocytes 4-5h after oocyte retrieval according to our standard operating procedure in both groups of patients.
After oocyte retrieval and fertilization, oocytes were cultivated in universal culture medium (Gynemed Medizinprodukte GmbH \& Co. KG, Germany). After 14-16 h, fertilization check was performed. All normal fertilized embryos with two pronuclei (PN) were then cultured using Embryoslide dishes in Embryoscope® time-lapse incubator (both Vitrolife AB, Sweden). With the built-in camera and microscope, images of the developing embryo were taken every 15 min in seven different layers. Definition of morphokinetic parameters was performed according to the criteria proposed by Ciray et al. and was analyzed with software developed for time-lapse image analysis (Embryoviewer® software; Vitrolife AB, Sweden).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELONVA | – | Drug: ELONVAPatients stimulated with Elonva |
| PUREGON | – | Drug: PUREGONPatients stimulated with Puregon |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women suffering from infertility
Key inclusion criteria (5 listed)
- Age: 18-42
- BMI: 19-29.9
- Primary or secondary infertility
- Ovarian stimulation with Elonva/Puregon
- Embryos cultured in embryoscope
Key exclusion criteria (2 listed)
- unexpected low response
- genetic testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELONVAElonva is a solution for injection that contains the active substance corifollitropin alfa. It is available as a pre-filled syringe (100 and 150 micrograms).Elonva is used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries. | Drug | ELONVA |
| PUREGONPuregon contains the active substance follitropin beta. fertilisation). Puregon is administered to stimulate the ovaries to produce more than one egg at a time | Drug | PUREGON |
Primary outcome
Time of pronuclei disappearance
Time frame: 16-18 hours after fertilization
Time of pronuclei disappearance in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Two discrete cells
Time frame: 26-28 hours after fertilization
The first observation of two discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Three discrete cells
Time frame: 28-44 hours after fertilization
The first observation of three discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Four discrete cells
Time frame: 44-45 hours after fertilization
The first observation of four discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Five discrete cells
Time frame: 44-68 hours after fertilization
The first observation of five discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Six discrete cells
Time frame: 44-68 hours after fertilization
The first observation of six discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Seven discrete cells
Time frame: 44-68 hours after fertilization
The first observation of seven discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Eight discrete cells
Time frame: 68-69 hours after fertilization
The first observation of eight discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Nine discrete cells
Time frame: 69-92 hours after fertilization
The first observation of nine discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
Morula stage
Time frame: 92 hours after fertilization
End of the compaction process; when observable compaction is complete in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON
8 secondary outcomes
Number of oocytes retrieved
Time frame: Number of oocytes retrieved will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)
Stage of oocyte development
Time frame: Stage of oocytes retrieved will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)
Fertilized oocytes
Time frame: Number of fertilized oocytes will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)
Embryo grading
Time frame: The quality of embryos will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)
Biochemical pregnancy (measurement of beta hCG)
Time frame: Biochemical pregnancies will be evaluated after successful implantation (1 week after embryo transfer)
Life birth
Time frame: Life births will be evaluated after successful pregnancy (9 moths after embryo transfer)
Weight (kilograms)
Time frame: Weight of the newborn will be evaluated after birth (9 moths after embryo transfer)
Height (centimeters)
Time frame: Height of the newborn will be evaluated after birth (9 moths after embryo transfer)
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 29 Oct 2019.
- Background: PubMed 25200818Gryshchenko MG, Pravdyuk AI, Parashchyuk VY. Analysis of factors influencing morphokinetic characteristics of embryos in ART cycles. Gynecol Endocrinol. 2014 Oct;30 Suppl 1:6-8. doi: 10.3109/09513590.2014.945763.
- Background: PubMed 24581983Wissing ML, Bjerge MR, Olesen AI, Hoest T, Mikkelsen AL. Impact of PCOS on early embryo cleavage kinetics. Reprod Biomed Online. 2014 Apr;28(4):508-14. doi: 10.1016/j.rbmo.2013.11.017. Epub 2013 Dec 17.
- Background: PubMed 25395178Chawla M, Fakih M, Shunnar A, Bayram A, Hellani A, Perumal V, Divakaran J, Budak E. Morphokinetic analysis of cleavage stage embryos and its relationship to aneuploidy in a retrospective time-lapse imaging study. J Assist Reprod Genet. 2015 Jan;32(1):69-75. doi: 10.1007/s10815-014-0372-3. Epub 2014 Nov 14.
- Background: PubMed 25316446Armstrong S, Vail A, Mastenbroek S, Jordan V, Farquhar C. Time-lapse in the IVF-lab: how should we assess potential benefit? Hum Reprod. 2015 Jan;30(1):3-8. doi: 10.1093/humrep/deu250. Epub 2014 Oct 14.
- Background: PubMed 25690157Milewski R, Kuc P, Kuczynska A, Stankiewicz B, Lukaszuk K, Kuczynski W. A predictive model for blastocyst formation based on morphokinetic parameters in time-lapse monitoring of embryo development. J Assist Reprod Genet. 2015 Apr;32(4):571-9. doi: 10.1007/s10815-015-0440-3. Epub 2015 Feb 18.
- Background: PubMed 25444507VerMilyea MD, Tan L, Anthony JT, Conaghan J, Ivani K, Gvakharia M, Boostanfar R, Baker VL, Suraj V, Chen AA, Mainigi M, Coutifaris C, Shen S. Computer-automated time-lapse analysis results correlate with embryo implantation and clinical pregnancy: a blinded, multi-centre study. Reprod Biomed Online. 2014 Dec;29(6):729-36. doi: 10.1016/j.rbmo.2014.09.005. Epub 2014 Sep 21.
- Individual participant dataSharing planned: Undecided. It has to be clarified with MERCK if sharing of data is applicable for this project.
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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.
Michael Schenk, Dr. principal investigator
Das Kinderwunsch Institut Schenkg GmbH
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 Kinderwunsch Institut GmbH at 1 site in Austria.
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 5 inclusion and 2 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 29 Oct 2019. 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 Austria. 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?
Time of pronuclei disappearance (time frame: 16-18 hours after fertilization). The study lists 10 primary outcomes in all. 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 NCT04142190, which also lists 6 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 29 Oct 2019.