ART ACT 2021 - IVF | ICU | ICSI | OI/TI

    ART ACT 2021

    (Parliament passed the bill in December 2021. Act came into effect in June 2023)

    Hegde Fertility

    [ART RULES 2022]

    Main objective

    • To regulate ART clinics and banks
    • To prevent misuse
    • To ensure safe and ethical practice by clinicians and ART centers
    • To use data for research and development

    Pre-requisites of patients to avail fertility treatments

    • The Female partner age should be between 21-50 years
    • The Male partner age should be between 21-55 years
    • The Couple should be married
    • To provide Aadhar cards for identification
    • A single woman can undergo IUI with donor sperm

    Pre-requisites for the clinic to perform fertility services

    • Centre to be registered under The Surrogacy (Regulation) Act, 2021
    • Registration to be displayed
    • To have qualified doctors/embryologists/support staff
    • Periodically update the national registry about the treatments/outcomes of registered couples.
    • Should have a grievance cell
    • Maintain all records of cases as prescribed by The ART Regulation ACT, 2021

    Clinics should be registered based on the services they provide

    1

    Level 1 clinic

    • Evaluation of the couple
    • Ovulation induction
    • IUI

    2

    Level 2 clinic

    • Evaluation of the couple
    • Ovulation induction
    • IUI
    • IVF/ICSI
    • PGT/PGD
    • Donor sperm/ Donor egg programs

    3

    Surrogacy clinic

    • Where surrogacy is done for indicated cases
    • Has to be altruistic (not commercial)
    • The surrogate has to be insured for a period of 36 months and all her medical expenses are to be borne by the intending couple

    Sourcing of donor eggs

    art act 2021

    Sourcing of donor eggs

    • Evaluation, recruitment, and allocation to the couple are done by ART bank
    • Stimulation, egg collection and IVF are done by a registered level 2 clinic
    • Donor recruitment is to be done as per rules and regulations
    • All safety precautions like mild stimulation, donor insurance, etc to be ensured

    Sourcing of sperm

    • Donor evaluation, recruitment and allocation to the couple are done by the ART bank
    • Clinic to procure samples from the ART Bank

    Surrogacy ACT

    • A clinic should be registered as a separate surrogacy clinic under The Surrogacy (Regulation) Act, 2021.
    • Couple should have a valid indication.
    • Couple should not have a living child (unless challenged).
    • They should use their own gametes, both sperm and eggs, or in specific cases, self sperm with donor oocyte.
    • Age criteria for intending couple: Female should be between 23–50 years and male between 26–55 years.
    • Single women (widow/divorced) can plan surrogacy with self-eggs and donor sperm.
    • It should be an altruistic surrogacy (no commercialization)- a relative or friend should act as a surrogate.
    • Proper evaluation of the surrogate is to be done.
    • All documents are to be procured and submitted as prescribed by the law.
    • Clinic to fulfill the criteria prescribed by the law.
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