In Vitro Fertilization (IVF)NCT06812663
Assessment of Some Metabolic and Hematological Markers in Women Exposed to in Vitro Fertilization
An observational study of In Vitro Fertilization (IVF), run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- In Vitro Fertilization (IVF)
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 30 years of age and above, presenting with any infertility concern and BMI 18.5-38 kg/m2.
Who may be able to join
- Women aged 30 years of age and above,
- presenting with any infertility concern
- BMI 18.5-38 kg/m2
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
Read the 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
- Conditions
- In Vitro Fertilization (IVF)
- Keywords
- metabolic and hematological markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IVF women | Women aged 30 years of age and above, presenting with any infertility concern and BMI 18.5-38 kg/m2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in metabolic marker level
change in glucose levels during pregnancy period in IVF women
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro Fertilization (IVF)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Salah Hassan Omar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812663
- Sponsor's protocol ID
- metabolic and hematologicalIVF
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Some Metabolic and Hematological Markers in Women Exposed to in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT06812663
- Acronym / sponsor ID
- metabolic and hematologicalIVF
- Conditions
- In Vitro Fertilization (IVF)
- Keywords
- metabolic and hematological markers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVF women | – | –Women aged 30 years of age and above, presenting with any infertility concern and BMI 18.5-38 kg/m2. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 30 years of age and above, presenting with any infertility concern and BMI 18.5-38 kg/m2.
Key inclusion criteria (3 listed)
- Women aged 30 years of age and above,
- presenting with any infertility concern
- BMI 18.5-38 kg/m2
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in metabolic marker level
Time frame: 9 month
change in glucose levels during pregnancy period in IVF women
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for In Vitro Fertilization (IVF)
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of In Vitro Fertilization (IVF), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amal Salah Hassan Omar, residant doctor (+201021964949, amalsalah9977@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in metabolic marker level (time frame: 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.