NCT06812663

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Mar 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Mar 2025May 2027

First Submitted

Initial submission to the registry

February 3, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 3, 2025

Last Update Submit

February 3, 2025

Conditions

Keywords

metabolic and hematological markers

Outcome Measures

Primary Outcomes (1)

  • Changes in metabolic marker level

    change in glucose levels during pregnancy period in IVF women

    9 month

Study Arms (1)

IVF women

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

Eligibility Criteria

Age30 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Amal Salah Hassan Omar, residant doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residdant doctor

Study Record Dates

First Submitted

February 3, 2025

First Posted

February 6, 2025

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

February 6, 2025

Record last verified: 2025-02