In Vitro Fertilization Impact on Metabolic Parameters

NCT03426228 | Completed Results

• 1 other identifier: DSREC-11/2017_09
• Study Type: observational
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

A quantitative prospective cohort study will be conducted, where blood samples will be collected at different timings during the IVF protocol, to assess the impact of fertility medications on metabolic parameters of patients undergoing IVF treatment.

Conditions

GDM; Insulin Resistance; Glucose Intolerance; PCOS; Obesity

Keywords

IVF, Glucose Homeostasis, Metabolic Parameters

Outcome Measures

Primary Outcomes (1)

• Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment

  Participants who experience an abnormal increase in fasting glucose (\>110) and A1C (\>5.7) will be identified post-treatment. Also, for those previously known to be insulin-resistant, HOMA ratio will help identifying whether the treatment worsens or has no effect on their insulin resistance state.

  12 weeks of pregnancy

Secondary Outcomes (2)

• Effect of Fertility Medications on Lipids Profile

  12 weeks of pregnancy

• Effect of Fertility Medications on Thyroid Function

  12 weeks of pregnancy

Other Outcomes (1)

• Long-term Effect of Fertility Medications in Relation to Maternal and Fetal Outcomes

  9 months of pregnancy

Interventions

HbA1C DIAGNOSTIC_TEST

After overnight fasting, 10 ml of blood will be collected at four different timings during the IVF protocol: 1. At baseline (second day of the menstrual period) 2. Triggering phase (post-egg retrieval procedure) 3. Embryo transfer phase (post-transfer procedure) 4. Week 4 (positive bHCG) 4\. Week 8 of pregnancy

Also known as: Lipid profile, Hormonal profile: FSH, LH, progesterone, estrogen,Beta-HCG, Serum Insulin level, Fasting Glucose level, Thyroid-Stimulating Hormone

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: We will have two main groups of: Obese (BMI: 30-38) and non-obese (BMI: 18.5-29.9) women with the following criteria
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A convenience sample from adult women of \< 39 years of age undergoing fresh IVF treatment at Fakih IVF Clinic in Dubai will be chosen. Participants who will fulfill the inclusion criteria will be recruited.

You may qualify if:

• Presenting with or without PCOS
• Presenting with structural or mechanical infertility, such as fallopian tube obstruction, endometriosis, fibroids
• Presenting with male factor
• Presenting with or without insulin resistance
• Combination of more than one of the listed above criteria

You may not qualify if:

• Pre-diabetes or diabetes patients (confirmed by impaired or abnormal OGTT)
• Age above 39 years of age
• Taking glucose-lowering meds, such as metformin or janumet.
• Taking corticosteroids

Sponsors & Collaborators

• University of Warwick: lead
• Fakih IVF Fertility Center: collaborator
• University of Sharjah: collaborator

Study Sites (1)

Fakih IVF

Dubai, 72960, United Arab Emirates

Location

Related Publications (2)

• Coussa A, Hasan HA, Barber TM. Effects of in vitro fertilization (IVF) therapies on metabolic, endocrine and inflammatory status in IVF-conceived pregnancy. Clin Endocrinol (Oxf). 2020 Dec;93(6):705-712. doi: 10.1111/cen.14270. Epub 2020 Jul 9.

  PMID: 32578220 BACKGROUND

• Coussa A, Hasan HA, Barber TM. Impact of contraception and IVF hormones on metabolic, endocrine, and inflammatory status. J Assist Reprod Genet. 2020 Jun;37(6):1267-1272. doi: 10.1007/s10815-020-01756-z. Epub 2020 Mar 25.

  PMID: 32215823 RESULT

MeSH Terms

Conditions

Insulin Resistance; Glucose Intolerance; Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Ayla Coussa
• Organization: Fakih IVF

A.coussa@warwick.ac.uk

+971501403866

Study Officials

• Ayla Coussa, Dietitian

  Fakih IVF Dubai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc.

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: February 8, 2018
• Study Start: February 15, 2018
• Primary Completion: August 1, 2019
• Study Completion: January 5, 2020
• Last Updated: July 14, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After conducting data collection and analysis the results will be available upon official publication.
• Access Criteria: Data access requests will be reviewed by an external independent committee. Requestors will be required to sign a Data Access Agreement.

Locations

AE (1)