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ART Level 2 Clinic

Minimum staff requirement

• One gynecologist
  • MD/MS/DNB/PG Diploma in OBGYN + minimum 50 oocyte pickup + 3 years of experience in infertility
  • Medical postgraduate in OBGYN with superspecialist Doctorate of Medicine/Fellowship in reproductive medicine + 3 years of experience in infertility
• One Anaesthetist
  • Medical post-graduate in Anesthesia
• One embryologist
  • Postgraduate in clinical embryology (full-time program with minimum four semesters) + 3 years of human ART laboratory experience in handling human gametes and embryos
  • Ph.D. (Full-time- thesis related to clinical embryology or ART or fertility) + one year of human ART laboratory experience in handling human gametes and embryos
  • Medical graduate (MBBS) or veterinary graduate (BVSc) + full time postgraduate degree in clinical embryology + human ART laboratory experience of at least two years
  • Postgraduate in Biotechnology/life sciences with a minimum of one year of onsite full-time clinical embryology certified training + four years of experience in handling human gametes and embryos in a registered ART level 2 clinic
• One counsellor
  • Graduate in Psychology/ clinical psychology/ Nursing/ Life sciences

Additional Staff (may be employed but not mandatory)

• Director
  • Postgraduate degree in medical sciences/life sciences/ management
• Andrologist
  • MCh/DNB in urology
  • MS general surgery
  • MCh/FNB/DM in reproductive medicine

Minimum 2 years of experience + hands-on experience of a minimum of 15 surgical sperm retrieval (PESA/TESA/TESE/MESA/MICROTESE procedures)

Equipment and Infrastructure

The following are the minimum requirements to get registered as a Level 1 ART clinic,

1. Microscope
2. Incubator (minimum of 2)
3. Laminar Airflow
4. Sperm counting chambers
5. Centrifuge
6. Refrigerator
7. Equipment for cryopreservation
8. Ovum aspiration pump
9. USG machine with TVS probe and needle guard
10. Test tube warmer
11. Anesthesia resuscitation trolley

What can the ART Level 2 clinic do?

1. OPD consultation
2. Folliculometry by USG
3. IUI
4. IVF
5. ICSI
6. PGT
7. Any surgical sperm extraction procedure – TESA/PESA/TESE/MICRO TESE and research
8. Donor IUI/IVF
9. Donor sperm procured from the ART bank can be stored in the level 2 clinic if not used immediately
10. Donor oocytes can be procured from the ART bank
11. Perform donor oocyte retrieval (shall retrieve all formed follicles but utilize only 7 oocytes)
12. Donor oocyte can be used with the husband’s sperm of a prespecified intending couple
13. Donor oocyte can be fertilized with donor sperm if clinically intended (if aspermia/azoospermia/poor sperm quality in the prespecified intending couple)
14. 7 donor oocytes may be frozen for future use for the intending couple only
15. Single mother IVF/ICSI with donor sperm if she is clinically indicated to avail of IVF

What ART Level 2 clinic cannot do?

1. Cannot perform donor sperm cryopreservation
2. Cannot offer surrogacy-related services (if there is surrogacy registration along with ART level 2 registration)

The following Consent forms are to be maintained in the ART level 2 clinic

ART Bank

ART banks facilitate the storage and distribution of human sperm/ oocytes/embryos for future use in ART.

Registration Fees for ART bank is 50,000 INR for 5 years

Minimum Staff requirements

1. Registered Medical Practitioner (Trained in the handling, preparation, and storage of semen samples)

Equipment and Infrastructures

1. Centrifuge
2. Incubator
3. Microscope
4. Laminar Airflow

What can ART Bank do?

What ART bank cannot do?

1. Ovarian stimulation
2. Perform any ART procedures such as gamete retrieval
3. ART treatments such as IUI/ICSI/IVF/ET/surrogacy to any patient

The ART banks should maintain

1. Record of use of donor gametes as specified in Forms 14, 14 A and 14B
2. consent form for the donor of sperm as specified in Form 15

Surrogacy Clinic

The surrogacy clinic will guide a commissioning couple/ woman by providing them with range of services required in the process including matching intended parents with surrogates, medical screening and evaluation, legal guidance, support throughout the surrogacy journey.

Registration fee of 2,00,000 INR for 3 years

Staff requirements

Staff requirements and their qualification are all similar to ART Level 2 Clinic

Equipment and Infrastructures

They are all similar to ART Level 2 Clinic

What can the Surrogacy clinic do?

They can perform all surrogacy-related procedures such as

1. 1. Intrauterine insemination using husband Semen (IUI-H)
2. Intra-uterine insemination using Donor Semen (IUI-D)
3. In vitro fertilization with Embryo Transfer (IVF- ET)
4. Intra-cytoplasmic Sperm Injection (ICSI)
5. Processing of semen
6. Storage of gametes (sperm and oocyte) and or embryos of patients
7. Pre-implantation genetic testing

Record maintenance in the surrogacy clinic

The above information is subject to changes. To know about recent amendments to the ART Regulation Act and Surrogacy Regulation Act, click this link www.rtionline.gov.in

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