InfertilityNCT03607409
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
An observational study of Infertility, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
To evaluate the role of Inhibin A as bio marker for the number of mature oocytes, compared to Estradiol Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 150 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 9 Sep 2018to 4 Jul 2019
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients undergoing ovarian stimulation for IVF treatment
Who may be able to join
- Patients undergoing ovarian stimulation with gonadotropins in either a GnRH-agonist or GnRH-antagonist for IVF treatment due to primary / secondary infertility.
Who cannot join
- Patients undergoing a modified natural cycle stimulation protocol (Taymour cycle) Patients at risk for development of ovarian hyperstimulation syndrome (OHSS)
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
IVI Middle East Fertilty Clinic
Abu Dhabi, 60202
About this study
Official title: Role of Inhibin A as Biomarker for Ovarian Response to Stimulation With Gonadotropins for IVF Treatment
To evaluate the role of Inhibin A as bio marker for the number of mature oocytes, compared to Estradiol
Read the detailed description
Inhibin A could be an improved biomarker regarding the number of expected mature oocytes compared to estradiol.
- Conditions
- Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature oocytes
Patients undergoing ovarian stimulation with gonadotropins
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start9 Sep 2018
- Primary completion29 Jan 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Ansh Labs
- Responsible party
- Principal investigator, Barbara Lawrenz, ART Fertility Clinics LLC
- Investigators
- Barbara Lawrenz, PhD, Principal investigator, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607409
- Sponsor's protocol ID
- 1806-ABU-043-BL
- Status last verified
- Aug 2019
- First submitted
- 23 Jul 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schneyer AL, Fujiwara T, Fox J, Welt CK, Adams J, Messerlian GM, Taylor AE. Dynamic changes in the intrafollicular inhibin/activin/follistatin axis during human follicular development: relationship to circulating hormone concentrations. J Clin Endocrinol Metab. 2000 Sep;85(9):3319-30. doi: 10.1210/jcem.85.9.6767.
PubMed 10999828Hohmann FP, Laven JS, de Jong FH, Fauser BC. Relationship between inhibin A and B, estradiol and follicle growth dynamics during ovarian stimulation in normo-ovulatory women. Eur J Endocrinol. 2005 Mar;152(3):395-401. doi: 10.1530/eje.1.01871.
PubMed 15757856Abbara A, Vuong LN, Ho VNA, Clarke SA, Jeffers L, Comninos AN, Salim R, Ho TM, Kelsey TW, Trew GH, Humaidan P, Dhillo WS. Follicle Size on Day of Trigger Most Likely to Yield a Mature Oocyte. Front Endocrinol (Lausanne). 2018 Apr 25;9:193. doi: 10.3389/fendo.2018.00193. eCollection 2018.
PubMed 29743877
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inhibin A as Biomarker for Ovarian Response to Stimulation With Gonadotropins for IVF Treatment
- ClinicalTrials.gov ID
- NCT03607409
- Acronym / sponsor ID
- 1806-ABU-043-BL
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Collaborators
- Ansh Labs
- Study start
- 9 Sep 2018 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 31 Jul 2018 (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.
To evaluate the role of Inhibin A as bio marker for the number of mature oocytes, compared to Estradiol
Detailed description
Inhibin A could be an improved biomarker regarding the number of expected mature oocytes compared to estradiol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients undergoing ovarian stimulation for IVF treatment
Key inclusion criteria (1 listed)
- Patients undergoing ovarian stimulation with gonadotropins in either a GnRH-agonist or GnRH-antagonist for IVF treatment due to primary / secondary infertility.
Key exclusion criteria (1 listed)
- Patients undergoing a modified natural cycle stimulation protocol (Taymour cycle) Patients at risk for development of ovarian hyperstimulation syndrome (OHSS)
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
Number of mature oocytes
Time frame: 1 year
Patients undergoing ovarian stimulation with gonadotropins
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 8 Aug 2019.
- Background: PubMed 10999828Schneyer AL, Fujiwara T, Fox J, Welt CK, Adams J, Messerlian GM, Taylor AE. Dynamic changes in the intrafollicular inhibin/activin/follistatin axis during human follicular development: relationship to circulating hormone concentrations. J Clin Endocrinol Metab. 2000 Sep;85(9):3319-30. doi: 10.1210/jcem.85.9.6767.
- Background: PubMed 15757856Hohmann FP, Laven JS, de Jong FH, Fauser BC. Relationship between inhibin A and B, estradiol and follicle growth dynamics during ovarian stimulation in normo-ovulatory women. Eur J Endocrinol. 2005 Mar;152(3):395-401. doi: 10.1530/eje.1.01871.
- Background: PubMed 29743877Abbara A, Vuong LN, Ho VNA, Clarke SA, Jeffers L, Comninos AN, Salim R, Ho TM, Kelsey TW, Trew GH, Humaidan P, Dhillo WS. Follicle Size on Day of Trigger Most Likely to Yield a Mature Oocyte. Front Endocrinol (Lausanne). 2018 Apr 25;9:193. doi: 10.3389/fendo.2018.00193. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Barbara Lawrenz, PhD principal investigator
ART Fertility Clinics LLC
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 ART Fertility Clinics LLC at 1 site in United Arab Emirates.
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: finished, as of the sponsor's last update on 8 Aug 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 United Arab Emirates. 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?
Number of mature oocytes (time frame: 1 year). 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 NCT03607409, which also lists 3 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 8 Aug 2019.