New Diagnostic Test To Improve Chances of Pregnancy

Shardul Nautiyal - Mumbai

The success rate of infertility treatment, which is a low 45 to 48 per cent, may now get a boost with advanced test like Follicular Fluid FISH receiving popularity in Mumbai.

Benefits Of The Test

Dr Ameet Patki

The test is meant to detect low grade gonadal mosaicism, a chromosomal defect in the ovary. The test is particularly useful for couples with recurrent In-Vitro Fertilisation (IVF) failures, recurrent miscarriages or couples over the age of 40 and in women with ovarian pathologies like endometriosis. The test helps to decide whether one should go for IVF, as the success rate of IVF is poor in patients detected with this low grade genetic defect.

The man credited with introducing this pathbreaking test in Mumbai is Dr Ameet Patki, Head, ReGenesis, a Mumbai-based ART facility of Reliance Life Sciences.

The Study

In a study of 500 samples of follicular fluid, (fluid surrounding the oocyte), conducted over a period of three years from 2002 to 2005 at the Assisted Reproduction Centre, Dr Patki and his team analysed low grade genetic disorder in the follicular fluid. The incidence of low-grade genetic defects was found to be as high as 10 per cent.

The test is conducted on samples of follicular fluid, which is otherwise discarded during the process of an IVF cycle. The follicular fluid is aspirated trans-vaginally under ultrasound guidance as part of a procedure to retrieve eggs for IVF/ICSI. Only 10 cc of the fluid is required for this test. Follicular fluid plays a supportive role in the development of ovum as well as its nutrition. “The test is significant as low-grade genetic defects manifest into low pregnancy rates, high miscarriage rate, which affects the take home baby rate,” informs Dr Patki. While the average miscarriage rate is around 18 per cent in normal cases, it was as high as 63 per cent for low grade genetic defects. Further, pregnancy rates are around 25 per cent in such patients as against average pregnancy rate of 45-48 per cent in couples with normal follicular fluid.

The study also showed that the success rate of IVF varied in women with low grade genetic defects. While the success rate in IVF, generally, is around 45 per cent, the study showed that in women with low-grade genetic defects, it is 25 per cent.

Why FISH Has An Edge

So what makes Follicular Fluid FISH different from conventional blood test, which helps to detect a genetic or a chromosomal defect. In blood tests, the cells are cultured for seven to 10 days and then only about 10 to 15 cells are analysed. Hence, low grade defects are not necessarily detected. Further, cells are analysed only after the culture. In the FISH technique, 100 to 200 cells are analysed without subjecting them to any culturing methods. Hence, defects of low percentage can be easily picked up. Additionally, results are available within three to four days. All these advantages come at a price of Rs 3500.

The Infrastructure

"The test is definitely an improvement in the methodology of identifying genetic defects with the unfertilised eggs" -Dr Kaustubh Kulkarni Infertility Specialist, Siddhilife Mumbai

Advanced and sophisticated equipment like Olympus Microscope AX70, Cytovision Software and Applied Image system are required to conduct the test, the cost of which comes to around Rs 60 lakh. Samples are sent to the lab in a sterile container within 24 hours of collection for the test to be conducted.

The test has been patented in India in the year 2004 and in 2005 ReGenesis applied for US and worldwide patent. This study has won several distinguished awards, including the FOGSI Corion award for the best scientific research in 2004. The study was presented at the 19th Asian and Oceanic Congress of Obstetrics and Gynaecology at Korea in 2005, which fetched Dr Patki the Young Scientist Award and also the best scientific research award.

Expert Speak

Commenting on the viability of the test, Dr Shreyash Pargaonkar, a Mumbai-based infertility specialist said, “The credibility of the test can be attributed to its effective diagnosis of genetic defects. It will become popular more so in the medical fraternity, if the study gets published in a prestigious international scientific journal.”

Avers Dr Kaustubh Kulkarni, Infertility Specialist, Siddhilife, a Mumbai-based ART centre specialising in IVF/ICSI, “The test is definitely an improvement in the methodology of identifying genetic defects with the unfertilised eggs.” According to Dr Sharad Gogate, Geneticist and Perinatologist, “Research should be done on a larger scale in many more centres across the world before the final conclusion is drawn about Follicular Fluid FISH’s role in ART programme.”

About ReGenesis

The Assisted Reproduction Facility (ARF) at Reliance Life Sciences Pvt Ltd commenced its operations in August 2001. In June 2005, it was branded as ReGenesis. The Assisted Reproduction Wing offers advanced infertility treatment including Intra Uterine Insemination (IUI), In Vitro Fertilization (IVF), Intra Cytoplasmic Sperm Injection (ICSI), Sperm Retrieval Procedures like PESA, MESA, TESA, TESE, Laser Assisted Hatching (LAH), among other tests.