Assessment of Some Metabolic and Hematological Markers in Women Exposed to in Vitro Fertilization

February 3, 2025 updated by: Amal Salah Hassan Omar, Assiut University

Assisted reproductive technologies (ART) represent commonly utilized management strategies for infertility with multifactorial causes (including genetically predisposed diseases). Amongst ART, in vitro fertilization (IVF) is the most popular. IVF treatment may predispose the mother to increased risks and complications during pregnancy, and there may be adverse fetal outcomes. Hormonal therapies, including oral contraceptives, may impair glucose and lipid metabolism, and promote insulin resistance and inflammation.

In vitro fertilization therapy induces weight gain and impairment in glucose, insulin and lipid homeostasis in failed IVF. Improvement of glucose homeostasis, decrease in thyroid profile and increase in lipid profile in clinical pregnancy are likely a pregnancy-related effect.

Hyperglycemic pregnant women were proven to have a high prevalence of caesarean section, preterm delivery, low one-minute Apgar score, respiratory distress syndrome, neonatal jaundice, admission to the neonatal ICU, infants born large for gestational age (LGA), macrosomia.preconception abnormal glucose metabolism may increase the risk of adverse neonatal outcomes in PCOS women. The monitoring and management of preconception glucose homeostasis and IR are essential methods of improving the neonatal outcomes of PCOS women.

Successful implantation and placentation require well-balanced inflammation and immune tolerance. Apart from white blood cells, the role of platelets in the release of mediators that cause local changes in the inflammatory process is very relevant.

Increased levels of CBC inflammation markers may have a negative impact on IVF outcomes among nonobese women with UI.

Successful embryo implantation requires a favorable endometrium, good-quality embryos and delicate coordination between the embryo and endometrium. The tightly controlled inflammatory response in the window of receptivity is essential for successful implantation and growing evidence suggests that chronic inflammation is associated with RIF.

the aim of this study -To explore effects of IVF therapies on metabolic and endocrinal parameters in IVF-conceived pregnancy and its relation to outcome.

2- To investigate whether there could be an association between hematological infammatory markers and in vitro fertilization (IVF) success

Study Overview

Status

Not yet recruiting

Detailed Description

Assisted reproductive technologies (ART) represent commonly utilized management strategies for infertility with multifactorial causes (including genetically predisposed diseases). Amongst ART, in vitro fertilization (IVF) is the most popular. IVF treatment may predispose the mother to increased risks and complications during pregnancy, and there may be adverse fetal outcomes. Hormonal therapies, including oral contraceptives, may impair glucose and lipid metabolism, and promote insulin resistance and inflammation.

In vitro fertilization therapy induces weight gain and impairment in glucose, insulin and lipid homeostasis in failed IVF. Improvement of glucose homeostasis, decrease in thyroid profile and increase in lipid profile in clinical pregnancy are likely a pregnancy-related effect.

Hyperglycemic pregnant women were proven to have a high prevalence of caesarean section, preterm delivery, low one-minute Apgar score, respiratory distress syndrome, neonatal jaundice, admission to the neonatal ICU, infants born large for gestational age (LGA), macrosomia.preconception abnormal glucose metabolism may increase the risk of adverse neonatal outcomes in PCOS women. The monitoring and management of preconception glucose homeostasis and IR are essential methods of improving the neonatal outcomes of PCOS women.

Successful implantation and placentation require well-balanced inflammation and immune tolerance. Apart from white blood cells, the role of platelets in the release of mediators that cause local changes in the inflammatory process is very relevant.

Increased levels of CBC inflammation markers may have a negative impact on IVF outcomes among nonobese women with UI.

Successful embryo implantation requires a favorable endometrium, good-quality embryos and delicate coordination between the embryo and endometrium. The tightly controlled inflammatory response in the window of receptivity is essential for successful implantation and growing evidence suggests that chronic inflammation is associated with RIF.

the aim of this study -To explore effects of IVF therapies on metabolic and endocrinal parameters in IVF-conceived pregnancy and its relation to outcome.

2- To investigate whether there could be an association between hematological infammatory markers and in vitro fertilization (IVF) success

Study Type

Observational

Enrollment (Estimated)

115

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

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
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women aged 30 years of age and above, presenting with any infertility concern and BMI 18.5-38 kg/m2.

Description

Inclusion Criteria:

  • Women aged 30 years of age and above,
  • presenting with any infertility concern
  • BMI 18.5-38 kg/m2

Exclusion Criteria:

  • current or past history of diabetes mellitus, thyroid dysfunction and any other chronic medical condition such as hepatic, renal, respiratory, haematological and cardiovascular disease. Other exclusion criteria included use of any therapy that may affect glucose homeostasis, thyroid and/or lipid profile

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
IVF women
Women aged 30 years of age and above, presenting with any infertility concern and BMI 18.5-38 kg/m2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in metabolic marker level
Time Frame: 9 month
change in glucose levels during pregnancy period in IVF women
9 month

Collaborators and Investigators

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

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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • metabolic and hematologicalIVF

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on In Vitro Fertilization (IVF)

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