Clinical trial NCT06812663: Assessment of Some Metabolic and Hematological Markers in Women Exposed to in Vitro Fertilization
Official title: Assessment of Some Metabolic and Hematological Markers in Women Exposed to in Vitro Fertilization
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: In Vitro Fertilization (IVF)
Keywords: metabolic and hematological markers
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 115
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in metabolic marker level
timeFrame: 9 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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