Infertility Clinical Trial
Official title:
Association of the Mediterranean Diet With Fertility Outcomes: a Study Among Couples Undergoing in Vitro Fertilization Treatment
Infertility affects one of every six couples and one out of ten couples may seek fertility treatment such as ovulation induction and assisted reproductive technologies. With respect to diet, several dietary factors, i.e. micro-, macro-nutrients and individual food groups, have been associated with the risk of subfertility; however, more information is needed on the role of dietary factors in reproductive functions. However, evidence concerning the association between dietary patterns, such as the Mediterranean diet (MD) pattern, and fertility is scarce. The aim of this study is to investigate the relationship between preconception dietary patterns, especially the MD pattern, and in vitro fertilization (IVF) outcomes, as well as adiponectin and follistatin concentrations in the plasma and follicular fluid of women undergoing IVF treatment. Blood and follicular fluid adiponectin and follistatin concentrations will be measured on each day of the ovarian stimulation protocol. Main IVF treatment outcomes are fertilization rate, oocyte and embryo quality, implantation, clinical pregnancy and live birth rates.
Infertility affects one of every six couples and one out of ten couples may seek fertility
treatment such as ovulation induction and assisted reproductive technologies. There are
multiple causes of infertility, including ovulatory disorders, endometriosis and sperm
factors, or even psychological problems, among others. Modifiable lifestyle factors, such as
diet, smoking and physical activity, may also affect fertility. With respect to diet,
several dietary factors, i.e. micro-, macro-nutrients and individual food groups, have been
associated with the risk of subfertility; however, more information is needed on the role of
dietary factors in reproductive functions. A more comprehensive approach to investigate the
associations between dietary factors and health outcomes is to assess the impact of the
overall diet rather than separate foods or nutrients. However, evidence concerning the
association between dietary patterns, such as the Mediterranean diet (MD) pattern, and
fertility is scarce. The benefits of the MD on health have been well-publicized; it is
associated with a significant reduction of overall mortality, cardiovascular disease and
cancer. Adherence to the MD also seems to reduce the risk of weight gain and diabetes,
conditions that raise insulin resistance and may thus lead to ovulatory infertility.
Recently, adherence to MD was also associated with an increase in circulating adiponectin
levels, a hormone produced by the adipose tissue that acts to reduce insulin resistance.
Interestingly, adiponectin has been shown to exert actions in the female reproductive
system, including the hypothalamic-pituitary ovarian axis and endometrium, and thus, it can
be hypothesized that MD may exert a beneficial effect on reproductive functions through a
raising effect on adiponectin levels. The aim of this study is to investigate the
relationship between preconception dietary patterns, especially the MD pattern, and in vitro
fertilization (IVF) outcomes, as well as adiponectin and follistatin concentrations in the
plasma and follicular fluid of women undergoing IVF treatment.
Two-hundred subfertile couples undergoing IVF treatment at a Fertility Clinic in Athens
(www.embryogenesis.gr/) will be invited to participate. Participants will fill out the
following questionnaires: a general questionnaire to record the baseline characteristics of
the subjects (age, educational level, annual income, medical history, body mass index,
smoking, etc), a semi-quantitative 77-item food frequency questionnaire to assess habitual
dietary intakes, and a 40-item state-trait anxiety inventory instrument to measure anxiety
symptoms. Dietary patterns will be evaluated using principal component analysis and factor
analysis. Adherence to the MD will be assessed with a MD-score that incorporates the
inherent characteristics of this traditional diet, that is, high intake of plant foods and
olive oil, low intake of meat and dairy products, and moderate intake of alcohol. Blood and
follicular fluid adiponectin and follistatin concentrations will be measured on each day of
the ovarian stimulation protocol. Main IVF treatment outcomes are fertilization rate, embryo
quality, implantation, clinical pregnancy and live birth.
Associations between dietary patterns, adiponectin and follistatin concentrations and the
IVF treatment outcomes will be tested using linear and logistic regression analyses,
adjusting for potential confounders (e.g. age, smoking, anxiety symptoms, etc). The findings
of the study could contribute in the development of guidelines to prevent infertility or to
nutritional management associated to infertility treatments to improve reproductive
performance. Furthermore, the elucidation of the role of adiponectin and follistatin in
female reproductive functions and its association with dietary variables and the IVF
outcomes could lead to the use of adiponectin or follistatin as therapeutic targets in novel
treatment strategies of infertility disorders.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A |