NCT03607409

Brief Summary

To evaluate the role of Inhibin A as bio marker for the number of mature oocytes, compared to Estradiol

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 9, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

July 23, 2018

Last Update Submit

August 6, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of mature oocytes

    Patients undergoing ovarian stimulation with gonadotropins

    1 year

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing ovarian stimulation for IVF treatment

You may qualify if:

  • Patients undergoing ovarian stimulation with gonadotropins in either a GnRH-agonist or GnRH-antagonist for IVF treatment due to primary / secondary infertility.

You may not qualify if:

  • Patients undergoing a modified natural cycle stimulation protocol (Taymour cycle) Patients at risk for development of ovarian hyperstimulation syndrome (OHSS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Middle East Fertilty Clinic

Abu Dhabi, 60202, United Arab Emirates

Location

Related Publications (3)

  • 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.

    PMID: 10999828BACKGROUND

  • Hohmann 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.

    PMID: 15757856BACKGROUND

  • Abbara 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.

    PMID: 29743877BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood extraction

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Barbara Lawrenz, PhD

    ART Fertility Clinics LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Director

Study Record Dates

First Submitted

July 23, 2018

First Posted

July 31, 2018

Study Start

September 9, 2018

Primary Completion

January 29, 2019

Study Completion

July 4, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

AE(1)