1. Categories of Infertility /
ART Clinics
ASSISTED REPRODUCTIVE
TECHNOLOGY
(REGULATION) Rules – 2010
INDIAN COUNCIL OF MEDICAL RESEARCH
NEW DELHI

2. At
Certificate Course
IUI & Ovarian
Stimulation

3. Faculty
• Dr. Sharda Jain
Prog. Director , Course Chairperson
• Dr Jyoti Agarwal
Director /Course Co- Chair person
• Dr. Aruna saxena
Director Course Co- Chairperson
• Dr. Jyoti Bhaskar
Director
• Dr. Abhishek Singh Parihar
Director
• Dr. Sushma Ved
Director

4. Primary (Level 1) Infertility
Clinics
• Clinics where preliminary investigations are
carried out and type and cause of infertility
diagnosed.
• They may carry out all types of infertility
treatment that do not require handling
of sperm, egg or embryo outside of the body.
• Such a primary infertility care unit or clinic could
be a doctor’s consulting room, such as a
gynaecologist’s or a physician’s consulting room,
or even a general hospital.

5. • The gynaecologist or the physician in charge of
a Level 1 infertility care unit
should have an appropriate post-graduate
degree or diploma, and be capable
of taking care of the above responsibilities.
• All procedures like TVS , laparoscopy- short of
use of gonadotrophins for Ovulation Induction &
IUI
• These clinics will not require registration.

6. Secondary (Level 2) Infertility
Clinics
• These clinics will require registration under the Act.
• They shall have facilities for artificial insemination using
husband’s semen (AIH), artificial insemination
using donor semen (AID), and intrauterine insemination
(IUI) using husband’s or donor semen.
• They may have infrastructure for further in-depth
investigation and extended treatment of infertility except
where oocytes are handled outside the body.

7. Treatment Facilities at Level 2
• Facilities for semen preparation and IUI, including an
appropriate clean room for IUI.
• Provision for semen collection in men with a vibrator or
an electroejaculator in erectile dysfunction and
ejaculatory problems.
• Provision for extended treatment of infertility except for
oocyte pick up, in vitro fertilization (IVF), intracytoplasmic
sperm injection (ICSI), and similar techniques

8. Tertiary (Level 3) Infertility
Clinics
• These clinics will require registration and
will have three functions to perform
• Diagnostic and Therapeutic at the
highest level of specialization and with
best of facilities
• Research (excepting on human
embryos).

9. • If any of the facilities mentioned below
does not exist in the clinic, the clinic
should have access to such a facility in
another appropriately accredited
clinic, ART bank, or laboratory

10. Minimum Requirement Regarding Staff in
Infertility Clinics
• In the case of small Level 2 and Level 3 clinics, the
services of the Andrologist, Clinical Embryologist, and /
or of the Counsellor, may be shared
• Gynaecologist
• Andrologist
• Clinical Embryologist
• Counsellor
• Programme Co-ordinator / Director

11. Minimal Physical Requirements
for an ART Clinic
• The non-sterile area
• A reception and waiting room for patients
• An examination room with privacy
• A general-purpose clinical laboratory
• Store room
• Record room
• Autoclave room

12. • Steps for vermin proofing
• Semen collection room
• Semen processing laboratory
• Clean room for IUI

13. FORMS REQUIRED
• FORM – A
Form of Application for Registration or
Renewal of Registration of an Infertility/Art
Clinic
• FORM – B
Certificate of Registration

14. • FORM - E
Consent for Artificial Insemination or
Intrauterine Insemination with Husband’s
Semen / Sperm
• FORM - F
Consent for Artificial Insemination or
Intrauterine Insemination with Donor
Semen

15. FORM - E
Consent for Artificial Insemination or Intrauterine Insemination with
Husband’s Semen / Sperm
(See Rule 15.1)
_________________________________________ and __________________
_____________________________, being husband and wife and both of legal age,
authorize Dr.________________________ to inseminate the wife artificially or
intrauterine with the semen / sperm of the husband for achieving conception.
We understand that even though the insemination may be repeated as often as
recommended by the doctor, there is no guarantee or assurance that pregnancy or a
live birth will result.
We have also been told that the outcome of pregnancy may not be the same as
those of the general pregnant population, for example in respect of abortion, multiple
pregnancies, anomalies or complications of pregnancy or delivery.
The procedure carried out does not ensure a positive result, nor does it guarantee a
mentally and physically normal child. This consent holds good for all the cycles
performed at the clinic.
Endorsement by the ART Clinic
I / we have personally explained to _________________ and _________________
the details and implications of his / her / their signing this consent / approval form,
and made sure to the extent humanly possible that he / she / they understand these
details and implications.
Name, address and signature of the Witness from the clinic
Signed: _________________ (Husband)
_ ____________________(Wife)
Name and signature of the Doctor
Name and address of the ART clinic
Dated:

16. FORM - F
Consent for Artificial Insemination or Intrauterine Insemination with
Donor Semen
(See Rule 15.1)
We, ___________________________________________________________ and
____________________________, being husband and wife and both of legal age,
authorize Dr.___________________________ to inseminate the wife artificially or
intrauterine with semen / sperm of a donor (ART bank’s
no._______________________; obtained from _______________________ ART
bank with valid registration no……………….) for achieving conception.
We understand that even though the insemination may be repeated as often as
recommended by the doctor, there is no guarantee or assurance that pregnancy or a
live birth will result.
We have also been told that the outcome of pregnancy may not be the same as
those of the general pregnant population, for example in respect of abortion, multiple
pregnancies, anomalies or complications of pregnancy or delivery.
We declare that we shall not attempt to find out the identity of the donor.
I, the husband, also declare that should my wife bear any child or children as a
result of such insemination(s), such child or children shall be as my own and
shall be my legal heir(s).
The procedure carried out does not ensure a positive result, nor does it guarantee a
mentally and physically normal body. This consent holds good for all the cycles
performed at the clinic.
Endorsement by the ART Clinic
I/we have personally explained to ___________________ and ______________ the
details and implications of his / her / their signing this consent / approval form, and
made sure to the extent humanly possible that he / she / they understand these
details and implications.
Name, address and signature
of the Witness from the clinic