Maternal Transcriptomic Regulation of the Preimplantation Embryo

NCT02813746 | Unknown

• 1 other identifier: 1603-IGX-018-CS
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to understand the epigenetic and transcriptomic mechanisms that regulate the fetal origin of adult diseases (FOAD), either for the presence of metabolic disorders in the future mothers, such as obesity or for the exposure to certain contaminants such as tobacco. To do that, the miRNAs profiles secreted to the endometrial fluid in obese women vs normoweight women during the window of implantation will be identified. Likewise, it will be studied how that miRNA signature is normalized once a substantial loss of weight is produced by the patients involved in the studied. In parallel, a comparison of the miRNA expression profiles secreted in the endometrial fluid in smoker women vs nonsmoker women will be performed. As in the previous case, it will be studied if after the exposure to these contaminant, the normalization of the miRNA expression signature occurs. Finally, an in silico analysis will be carried out in order to define the target genes and the metabolic pathways affected by the miRNAs profile secreted in both pathological conditions

Conditions

Fetal Origin of Adult Diseases

Keywords

Obesity; Tobacco; Epigenetic; Transcriptomic; microRNAs; miRNAs

Outcome Measures

Primary Outcomes (1)

• Understanding of the epigenetic and transcriptomic mechanisms that regulate the FOAD

  The main objective of the present project is focused on understanding the epigenetic and transcriptomic mechanisms that regulate the fetal origin of adult diseases (FOAD) either by the presence of metabolic disorders in mothers such as obesity, or by the exposure to certain pollutants such as tobacco

  40 months

Secondary Outcomes (3)

• Analysis of the miRNA expression pattern in the endometrial fluid (EF) in obese patients Analysis of the miRNA expression profile in the endometrial fluid

  13 months

• Analysis of the miRNA expression pattern in the endometrial fluid (EF) in smoker patients

  13 months

• Functional analysis

  13 months

Study Arms (2)

Obese non smoker vs Normoweight non smoker

Endometrial fluid (EF) will be obtained from non-smokers normo-weight and obese patients in the receptive state. Samples will be collected 7 days after Luteinizing Hormone (LH) peak. They will be classified following the guidelines of the obesity classification system by the World Human Organization (WHO). Patients will be subjected to a fitness program during a year with the aim to achieve a weight reduction to normal values (19-24.9 kg/m2). The modifications in the miRNAs expression will be studied. After the weight loss, new EF will be collected from these patients.

Dietary Supplement: Fitness program; Procedure: Endometrial fluid collection

Normoweight smoker vs Normoweight non-smoker

EF will be obtained from non-smokers and smokers normo-weight in the receptive state. Samples will be collected 7 days after Luteinizing Hormone (LH) peak. Smokers patients will be urge to give up smoking during at least one year. After this time, new samples will be collected to determine if the non-exposition to this contaminant could exert any effect in the miRNAs signature. A regular control will be done in this group of patients to ensure that they have not been exposed to tobacco in 12 months. Professional support will be given in the same centre of the study to help the patient to accomplish its objective.

Behavioral: Stop smoking; Procedure: Endometrial fluid collection

Interventions

Fitness program DIETARY_SUPPLEMENT

Obese non smoker vs Normoweight non smoker

Stop smoking BEHAVIORAL

Normoweight smoker vs Normoweight non-smoker

Endometrial fluid collection PROCEDURE

Normoweight smoker vs Normoweight non-smoker; Obese non smoker vs Normoweight non smoker

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Endometrial fluids from non-smoker obese and normoweight samples will be analysed in the window of implantation. In turn, endometrial fluids from normoweight smoker and non-smoker patients will be analysed in the window of implantation. These participants will be recruited in just one centre: IVI Valencia. Their recruitment will be done through a routine consultation carried out by the research team from the centre, as well as through the revision and daily evaluation of the medical reports and subsequent contact with those patients who could accomplish with the criteria selection and desire to be involved in the study.

You may qualify if:

• Women with age comprised between 18 and 45 years
• Normal uterus (evaluated trough ultrasound 2D/3D and/or hysteroscopy)
• Presence of at least one ovary
• Body mass index:
• Normoweight: 18.0-24.9 kg/m2 and non smokers
• Obese ≥30.0 kg/m2 and non smokers
• Smokers: Normoweight and smoke at least 10 cigarettes per day

You may not qualify if:

• Overweight=25.0-29.9 kg/m2
• Patients with Intrauterine device in the last 3 months
• Patients who had had hormonal contraceptives in the 2 previous months.
• Adnexal or uterine pathologies
• Polycystic ovary
• Existence of serious or uncontrolled bacterial, fungal or viral infections that could interfere with the involvement of the patient in the study or in the evaluation of the study results.
• Any disease or medical condition that could be unstable or could endanger the security of the patient and her compliance in the study.

Sponsors & Collaborators

• Igenomix: lead

Study Sites (1)

IVI Valencia

Valencia, Valencia, 46015, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be analyzed in the endometrial fluid. These samples will be completely exhausted during the analysis.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Simón, MD PhD

  Igenomix

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Gomez, BSc MSc

CONTACT

+34963905310; carlos.gomez@igenomix.es

Diana Valbuena, MD PhD

CONTACT

+34963905310; diana.valbuena@igenomix.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director IGENOMIX; Gynaecologist IVI Valencia

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 27, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2019
• Last Updated: June 28, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)