GDMIVFNCT03426228
In Vitro Fertilization Impact on Metabolic Parameters
An observational study of GDM and Insulin Resistance, run by University of Warwick at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- GDM, Insulin Resistance, Glucose Intolerance
- What is being tested?
- HbA1C
- How many people
- 344 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 15 Feb 2018to 5 Jan 2020
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Fertility Drugs on Glucose Homeostasis and Other Metabolic Parameters on Patients Undergoing In Vitro Fertilization (IVF)
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.
Read the detailed description
Numerous factors predispose women to develop pregnancy-related complications, these include gestational diabetes (GDM), pre-pregnancy obesity, advanced maternal age (> 35 years) and gestational age, abnormal weight gain during pregnancy, family history of diabetes, PCOS and low parity. Evidenced-based studies reported that women with PCOS have a significantly higher risk of developing GDM compared with women without PCOS, independently of the obesity factor; this risk is higher when both factors coexist.
Given the known effect of reproductive hormones on weight-gain, controversies still exist on whether ART predispose women to more adverse obstetric outcomes compared to normal pregnancy. ART describes different procedures to help women become pregnant, with In Vitro Fertilization (IVF) being the most commonly performed. It has been demonstrated that IVF is associated with glucose intolerance in mice and it will be interesting to determine whether this physiologic phenomenon is also altered by IVF medication (such as estrogen and progesterone) in humans. While some studies reported that singleton pregnancies conceived by ART (IVF or ovulation induction) were strongly associated with GDM compared to spontaneous conceptions, other studies did not find significant differences in the risk of GDM. Increased GDM risk presented with IVF can be associated with prenatal obesity or secondary to maternal PCOS condition. The former studies did not specify the body mass index (BMI) and the medical history of participants undergoing IVF, such as the presence of PCOS. Due to limited available data, we still cannot distinguish whether these adverse pregnancy outcomes are due to the pre-existing conditions such as PCOS, or are secondary to the IVF therapy itself.
- Conditions
- GDM, Insulin Resistance, Glucose Intolerance, PCOS, Obesity
- Being tested
- HbA1C
- Keywords
- IVF, Glucose Homeostasis, Metabolic Parameters
- Medical subject headings
- Insulin Resistance, Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HbA1CDiagnostic test
Also called Lipid profile, Hormonal profile: FSH, LH, progesterone, estrogen,Beta-HCG, Serum Insulin level, Fasting Glucose level
After overnight fasting, 10 ml of blood will be collected at four different timings during the IVF protocol:
- At baseline (second day of the menstrual period)
- Triggering phase (post-egg retrieval procedure)
- Embryo transfer phase (post-transfer procedure)
- Week 4 (positive bHCG)
- Week 8 of pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks of pregnancy
Secondary outcomes (2)
Effect of Fertility Medications on Lipids Profile
Lipid profile will be measured before and after treatment; participants experiencing hypercholesterolemia post-treatment will be consulted by a dietitian to help them better manage the condition during their pregnancy (total chol, LDL and triglycerides)
Measured: 12 weeks of pregnancy
Effect of Fertility Medications on Thyroid Function
TSH level will be measured pre- and post-IVF. Early diagnosis of thyroid dysfunction will be closely monitored with frequent repetitions of blood test, especially during the first trimester.
Measured: 12 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start15 Feb 2018
- Primary completion1 Aug 2019
- Study completion5 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GDMStudies of the same condition, open and under way.
- 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
- 344 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Collaborators
- Fakih IVF Fertility Center, University of Sharjah
- Responsible party
- Principal investigator, Ayla Coussa, University of Warwick
- Investigators
- Ayla Coussa, Dietitian, Principal investigator, Fakih IVF Dubai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426228
- Sponsor's protocol ID
- DSREC-11/2017_09
- Acronym
- IVF
- Status last verified
- Jul 2021
- First submitted
- 3 Jan 2018
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the study information will be kept confidential. Patients' names will not be identified in any publication or presentation of the study findings. Only groups' results will be reported.
Publications
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.
PubMed 32578220Coussa 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.
PubMed 32215823
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fertility Drugs on Glucose Homeostasis and Other Metabolic Parameters on Patients Undergoing In Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT03426228
- Acronym / sponsor ID
- IVF / DSREC-11/2017_09
- Conditions
- GDM, Insulin Resistance, Glucose Intolerance, PCOS, Obesity
- Keywords
- IVF, Glucose Homeostasis, Metabolic Parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Collaborators
- Fakih IVF Fertility Center, University of Sharjah
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 5 Jan 2020 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Posted 13 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Numerous factors predispose women to develop pregnancy-related complications, these include gestational diabetes (GDM), pre-pregnancy obesity, advanced maternal age (> 35 years) and gestational age, abnormal weight gain during pregnancy, family history of diabetes, PCOS and low parity. Evidenced-based studies reported that women with PCOS have a significantly higher risk of developing GDM compared with women without PCOS, independently of the obesity factor; this risk is higher when both factors coexist.
Given the known effect of reproductive hormones on weight-gain, controversies still exist on whether ART predispose women to more adverse obstetric outcomes compared to normal pregnancy. ART describes different procedures to help women become pregnant, with In Vitro Fertilization (IVF) being the most commonly performed. It has been demonstrated that IVF is associated with glucose intolerance in mice and it will be interesting to determine whether this physiologic phenomenon is also altered by IVF medication (such as estrogen and progesterone) in humans. While some studies reported that singleton pregnancies conceived by ART (IVF or ovulation induction) were strongly associated with GDM compared to spontaneous conceptions, other studies did not find significant differences in the risk of GDM. Increased GDM risk presented with IVF can be associated with prenatal obesity or secondary to maternal PCOS condition. The former studies did not specify the body mass index (BMI) and the medical history of participants undergoing IVF, such as the presence of PCOS. Due to limited available data, we still cannot distinguish whether these adverse pregnancy outcomes are due to the pre-existing conditions such as PCOS, or are secondary to the IVF therapy itself.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HbA1CAlso: Lipid profile, Hormonal profile: FSH, LH, progesterone, estrogen,Beta-HCG, Serum Insulin level, Fasting Glucose levelAfter 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 | Diagnostic test | – |
Primary outcome
Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment
Time frame: 12 weeks of pregnancy
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.
2 secondary outcomes
Effect of Fertility Medications on Lipids Profile
Time frame: 12 weeks of pregnancy
Effect of Fertility Medications on Thyroid Function
Time frame: 12 weeks of pregnancy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32578220Coussa 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.
- Results publication: PubMed 32215823Coussa 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.
- Individual participant dataSharing planned: Yes. All the study information will be kept confidential. Patients' names will not be identified in any publication or presentation of the study findings. Only groups' results will be reported.
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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. This study is not recruiting at the moment.
Ayla Coussa, Dietitian principal investigator
Fakih IVF Dubai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GDM and Insulin Resistance, run by University of Warwick at 1 site in United Arab Emirates.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 13 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment (time frame: 12 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03426228, which also lists 2 linked publications.
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 14 Jul 2021.