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MIHO Study - Milk drink to Improve the Health of Oocytes

A two week randomised, placebo-controlled, double blinded study of the efficacy of a novel milk drink for increasing follicular fluid insulin-like growth factor 1 concentration in women who respond poorly to ovarian stimulation during in vitro fertilisation

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001226998
Acronym
MIHO
Enrollment
39
Registered
2011-11-29
Start date
2012-11-09
Completion date
2014-08-18
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The purpose of this study is to determine if nutrients that have been shown to improve blood flow and increase circulating insulin-like growth factor 1 concentrations in the blood can improve both blood flow in the ovary and elevate the concentration of insulin-like growth factor 1 in the follicular fluid surrounding the eggs. The ability to increase the concentration of IGF-1 in follicular fluid surrounding the eggs in the ovary in this way may provide an inexpensive and simple alternative to growth hormone treatment for improving egg quality in patients undergoing IVF treatment.

Interventions

Participants will undergo their usual IVF treatment, but from the 3rd day of the IVF cycle they will be asked to consume 250ml of a milk-based drink in the morning and evening that will contain active components that might increase ovarian blood flow and follicular fluid insulin-like growth factor 1 concentrations, or a placebo. They will continue to consume the 250ml drink daily until the end of their IVF stimulation cycle. At the start and end of their cycle a blood sample will be collected to

Participants will undergo their usual IVF treatment, but from the 3rd day of the IVF cycle they will be asked to consume 250ml of a milk-based drink in the morning and evening that will contain active components that might increase ovarian blood flow and follicular fluid insulin-like growth factor 1 concentrations, or a placebo. They will continue to consume the 250ml drink daily until the end of their IVF stimulation cycle. At the start and end of their cycle a blood sample will be collected to measure circulating IGF-1 concentrations and the concentrations of reproductive hormones. During their routine day 9/10 follicle tracking scan, blood flow to the ovaries will also be measured using ultrasound. When their eggs are retrieved at the end of their IVF cycle the follicular fluid surrounding the eggs will be collected and analysed for IGF-1 and reproductive hormone concentrations.

Sponsors

University of South Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
25 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

Undergoing a gonadotrophin-releasing hormone antagonist cycle of IVF treatment and a poor responder to ovarian hyperstimulation. This includes meeting two of the following three criteria: 1. 40 years or older 2. previously only produced 3 or less mature eggs in response to maximal dose ovarian stimulation during IVF treatment 3. serum anti-mullerian hormone concentration < 7.8 pmol/l or a total antral follicle count <7 (both being accurate markers suggesting a reduced number of eggs left within your ovaries relative to your age).

Exclusion criteria

intolerant/allergic to cow's milk protein, lactose, soy, wheat, egg, gluten, nuts or seeds, concurrent use of human growth hormone, Elonva, long down regulation IVF cycle, oral corticosteroids (Prednisolone) therapy have used dehydroepiandrosterone therapy in last month

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026