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The effect of adherence to profertility diet on assisted reproduction outcomes

The effect of profertility dietary intervention on assisted reproduction outcomes: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130903014551N13
Enrollment
360
Registered
2023-08-12
Start date
2023-10-23
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Female Infertility. Condition 2: Male infertility. Female infertility Male infertility

Interventions

Intervention 1: Intervention group: the intervention in women will be as follows
supplementation with folate 1 mg/day, vitamin B12 500 mcg/day, vitamin D 1000 IU/day and omega-3 fatty acids 1000 mg/day- At least 4 servings/day from low-pesticide residue fruit and vegetables- maxim

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 42 Years

Inclusion criteria

Inclusion criteria: Age between 18 to 42 years BMI between 20 to 30 kg/m2 Consent to participate

Exclusion criteria

Exclusion criteria: Current or previous (within three months) drug use including oral contraceptive pills, hormone therapy, insulin sensitizers or antidiabetics, weight reducing compounds and dietary supplements History of chronic and endocrine disorders including diabetes and impaired glucose tolerance History of having more than 2 unsuccessful ART cycles Adherence to specific diets or exercise programs Tobacco or alcohol consumption Infertility due to tubal or uteri disorders Consumption of more than two servings of fatty fish per week

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate. Timepoint: At the end of the assisted reproductive technology cycle. Method of measurement: The presence of an intrauterine pregnancy confirmed by ultrasound at 6 weeks’ gestation.

Secondary

MeasureTime frame
Endometrial thickness and antral follicle count. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: Transvaginal sonography.;The number of retrieved, metaphase 2 and normal morphology oocytes. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: By embryologist.;Fertilization rate. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: The ratio of oocytes that reached the two-pronucleate (2PN) stage to the number of metaphase II (MII) oocytes.;Embryo formation rate. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: The ratio of embryos to oocytes with two pronuclei.;Embryo grade based on Scott criteria. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: By embryologist.;The number of transferred embryos. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: By infertility specialist.;Biochemical pregnancy rate. Timepoint: At the end of the ART cycle. Method of measurement: ?A serum b-human chorionic gonadotropin level >6 mIU/mL, typically measured 17 days (range,15 to 20 days) after egg retrieval.;Sperm quality parameters. Timepoint: At baseline and at the end of the trial. Method of measurement: By infertility specialist.;Serum folic acid level. Timepoint: At baseline and at the end of the trial. Method of measurement: Electrochemiluminescence immunoassay method.;Serum B12 level. Timepoint: At baseline and at the end of the trial. Method of measurement: Electrochemiluminescence immunoassay method.;Serum vitamin D level. Timepoint: At baseline and at the end of the trial. Method of measurement: ???????????? ???? ?? ?????? ????-???????? ????.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRahele Ziaei

Esfahan University of Medical Sciences

r.ziaei92@gmail.com+98 913 305 1052

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026