Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst?

February 6, 2024 updated by: Laura Melado, ART Fertility Clinics LLC

Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst? A Prospective Study

To investigate, whether on the day of egg retrieval, after ovarian stimulation for ICSI (intracytoplasmic sperm injection), there is a correlation between the intrafollicular AMH (Anti-Müllerian hormone) levels and the ploidy status of the blastocyst.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In clinical practice, AMH is used as a diagnostic and/or prognostic marker in women in association with ovulation induction and in various pathophysiological conditions. This study looks to investigate if the hormonal environment that surrounds an oocyte has an impact on the ploidy status of the blastocyst. Nowadays, using NGS (Next Generation Sequencing) platform for analysis of 23 pairs of chromosomes for Preimplantation Genetic Testing on blastocysts, the ploidy status of the embryo is more adequately assessed. Furthermore, embryo culture to blastocyst will provide further information about embryo quality and possibilities of implantation.

To have complete information between the serum hormones, follicular hormones, embryo development and ploidy will provide to clinicians, embryologist and patients further information on embryo selection and adequate ovarian stimulation protocols.

The database will be exported from the clinical information manager, VRepro, to a table in excel format through a database-based query system. The exported data will be duly codified to protect the clinical and personal information of the participants. Prior to the statistical study, an exploratory data analysis will be carried out to review the quality of the information extracted.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Female undergoing IVF treatment

Description

Inclusion Criteria:

  • At least one follicle from each ovary at day of trigger
  • Age from 18 to 40 years old
  • Normal menstrual cycle of 25-35 days
  • Poor, normal and high response will be included
  • First follicle punctured from each ovary will be consider for inclusion: if the COC (Cumulus Oocyte Complex) is present in clear FF (Follicular fluid), the FF will be collected separately for further analysis and the oocyte included in the study

Exclusion Criteria:

  • Very hematic follicular fluid
  • If the COC is not found in the follicular fluid
  • Azoospermia
  • Known chromosomal abnormalities
  • Severe OAT (Oligoasthenoteratozoospermia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
Procedure: ICSI
One oocyte injected at a time.
Procedure: Culture
One embryo per culture drop. Individual follow-up of the embryo development.
Genetic: Biopsy
One embryo per culture drop.
Procedure: Vitrification
One embryo per vitrification straw.
Procedure: OPU - Study Group
Measure the size of the follicle and aspirate only one follicle and flush. The needle before moving to the second ovary. Oocyte included in the study will be cultured separately (each ovary separately too).
Procedure: Denudation - Study Group
Oocyte included in the study will be denuded separately. Maturational stages are recorded per follicle.
Out of Study Group
Procedure: ICSI
One oocyte injected at a time.
Procedure: Culture
One embryo per culture drop. Individual follow-up of the embryo development.
Genetic: Biopsy
One embryo per culture drop.
Procedure: Vitrification
One embryo per vitrification straw.
Procedure: Oocyte Pick Up - Out of Study
Aspiration of follicles. search for the oocyte(s) All oocytes are grouped in one dish.
Procedure: Denudation - Out of Study
All oocytes are denuded together. Maturational stages are recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte maturity
Time Frame: 1 day
Calculated as percentage transformation of an oocyte from prophase I to metaphase II
1 day
Fertilization
Time Frame: 1 day
Percentage of mature oocytes - metaphase II (MII) that become 2 pronucleii embryos (2PN)
1 day
Blastulation
Time Frame: 1 day
Ability of the embryo to form a cavity (=to blastulate) 114-118 hours post ICSI. Number of blastocysts divided by the number of 2PN
1 day
Blastocyst quality
Time Frame: 6 days
Four Embryo Quality Scores (EQ1, 2, 3, 4) based on the expansion stage of the blastocyst, the grade of the inner cell mass and the grade of the trophectoderm.
6 days
Ploidy status
Time Frame: 14 days
Determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development
14 days
Mitochondria status
Time Frame: 14 days
Measured as mtDNA ratio, the ratio of mitochondrial DNA (mtDNA) read counts to autosomal (chromosome 1-22) DNA read counts
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMH in the follicular fluid.
Time Frame: 1 day
To evaluate if there is an association between the levels of serum AMH on day 2-3 of the stimulation, AMH day of OPU and the intra-follicular AMH.
1 day
FSH in the follicular fluid.
Time Frame: 1 day
To evaluate if there is an association between serum FSH on day 2-3 of the stimulation, serum FSH day of OPU and the intra-follicular FSH.
1 day
LH in the follicular fluid.
Time Frame: 1 day
To evaluate if there is an association between serum LH on day 2-3 of the stimulation, serum LH day of OPU and the intra-follicular LH.
1 day
E2 in the follicular fluid.
Time Frame: 1 day
To evaluate if there is an association between serum E2 on day 2-3 of the stimulation, serum E2 day of OPU and the intra-follicular E2.
1 day
P4 in the follicular fluid.
Time Frame: 1 day
To evaluate if there is an association between serum P4 on day 2-3 of the stimulation, serum P4 day of OPU and the intra-follicular P4.
1 day
Inhibin B in the follicular fluid.
Time Frame: 1 day
To evaluate if there is an association between serum Inhibin B on day 2-3 of the stimulation, serum Inhibin B day of OPU and the intra-follicular Inhibin B.
1 day
AMH in serum day of OPU
Time Frame: 1 day
To evaluate if there is an association between the levels of serum AMH on day 2-3 of the stimulation, AMH day of OPU and the intra-follicular AMH.
1 day
FSH in serum day of OPU
Time Frame: 1 day
To evaluate if there is an association between serum FSH on day 2-3 of the stimulation, serum FSH day of OPU and the intra-follicular FSH.
1 day
LH in serum day of OPU
Time Frame: 1 day
To evaluate if there is an association between serum LH on day 2-3 of the stimulation, serum LH day of OPU and the intra-follicular LH.
1 day
E2 in serum day of OPU
Time Frame: 1 day
To evaluate if there is an association between serum E2 on day 2-3 of the stimulation, serum E2 day of OPU and the intra-follicular E2.
1 day
P4 in serum day of OPU
Time Frame: 1 day
To evaluate if there is an association between serum P4 on day 2-3 of the stimulation, serum P4 day of OPU and the intra-follicular P4.
1 day
Inhibin B in serum day of OPU
Time Frame: 1 day
To evaluate if there is an association between serum Inhibin B on day 2-3 of the stimulation, serum Inhibin B day of OPU and the intra-follicular Inhibin B.
1 day
AMH in serum day of day 2/3 of stimulation.
Time Frame: 1 day
To evaluate if there is an association between the levels of serum AMH on day 2-3 of the stimulation, AMH day of OPU and the intra-follicular AMH.
1 day
FSH in serum day of day 2/3 of stimulation.
Time Frame: 1 day
To evaluate if there is an association between serum FSH on day 2-3 of the stimulation, serum FSH day of OPU and the intra-follicular FSH.
1 day
LH in serum day of day 2/3 of stimulation.
Time Frame: 1 day
To evaluate if there is an association between serum LH on day 2-3 of the stimulation, serum LH day of OPU and the intra-follicular LH.
1 day
E2 in serum day of day 2/3 of stimulation.
Time Frame: 1 day
To evaluate if there is an association between serum E2 on day 2-3 of the stimulation, serum E2 day of OPU and the intra-follicular E2.
1 day
P4 in serum day of day 2/3 of stimulation.
Time Frame: 1 day
To evaluate if there is an association between serum P4 on day 2-3 of the stimulation, serum P4 day of OPU and the intra-follicular P4.
1 day
Inhibin B in serum day of day 2/3 of stimulation.
Time Frame: 1 day
To evaluate if there is an association between serum Inhibin B on day 2-3 of the stimulation, serum Inhibin B day of OPU and the intra-follicular Inhibin B.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Laura Melado, PhD, ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2212-ABU-015-LM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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