Trial Outcomes & Findings for In Vitro Fertilization Impact on Metabolic Parameters (NCT NCT03426228)

Last Updated: 2021-07-14

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

344 participants

Primary outcome timeframe

12 weeks of pregnancy

Results posted on

2021-07-14

Participant Flow

702screened --\>673eligible to start IVF--\>359 had embryo transfer --\>191clinically confirmed pregnant+158 negative β-HCG+10 biochem pregnancy--\> 64drop-outs+10 miscarriage--\> Completed study and included in data: 158 pregnant+117 non-pregnant women

Participant milestones

Participant milestones
Measure	Non-Pregnant Negative BHCG at 4 weeks	Pregnant Positive BHCG at 4 weeks
Overall Study STARTED	158	191
Overall Study COMPLETED	117	158
Overall Study NOT COMPLETED	41	33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Pregnant n=117 Participants Negative BHCG at 4 weeks	Pregnant n=158 Participants Positive BHCG at 4 weeks	Total n=275 Participants Total of all reporting groups
Age, Continuous	32.5 years n=5 Participants	32 years n=7 Participants	32.3 years n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	158 Participants n=7 Participants	275 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	0 Participants n=7 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	0 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).
Race (NIH/OMB) Asian	9 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	16 Participants n=7 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	25 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	0 Participants n=7 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	0 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	8 Participants n=7 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	17 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).
Race (NIH/OMB) White	99 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	134 Participants n=7 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	233 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	0 Participants n=7 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	0 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	0 Participants n=7 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).	0 Participants n=5 Participants • At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test).

PRIMARY outcome

Timeframe: 12 weeks of pregnancy

Outcome measures

Outcome measures
Measure	Non-Pregnant n=117 Participants Negative BHCG at 4 weeks	Pregnant n=158 Participants Positive BHCG at 4 weeks
Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment Glucose, fasting	87.62 mg/dL Interval 79.3 to 95.9	82.19 mg/dL Interval 75.0 to 89.4
Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment Insulin, fasting	9.37 mg/dL Interval 4.0 to 14.8	9.45 mg/dL Interval 2.5 to 16.4

SECONDARY outcome

Timeframe: 12 weeks of pregnancy

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)

Outcome measures

Outcome measures
Measure	Non-Pregnant n=158 Participants Negative BHCG at 4 weeks	Pregnant n=117 Participants Positive BHCG at 4 weeks
Effect of Fertility Medications on Lipids Profile	199.5 mg/dL Interval 155.15 to 243.9	174.9 mg/dL Interval 126.9 to 222.9

SECONDARY outcome

Timeframe: 12 weeks of pregnancy

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.

Outcome measures

Outcome measures
Measure	Non-Pregnant n=158 Participants Negative BHCG at 4 weeks	Pregnant n=117 Participants Positive BHCG at 4 weeks
Effect of Fertility Medications on Thyroid Function	1.36 μIU/mL Interval 0.26 to 2.46	1.80 μIU/mL Interval 0.75 to 2.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months of pregnancy

Early management and/control of metabolic-related adverse outcomes in relation to IVF treatment will prevent GDM by for instance glucophage administration or regular blood test of TSH for participants reported to be at higher risk of thyroid dysfunction.

Outcome measures

Outcome data not reported

Adverse Events

Non-Pregnant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pregnant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ayla Coussa

Fakih IVF

Phone: +971501403866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place