Legal issues and Ethical considerations surrounding Egg Donation

Egg donation, embryo donation, semen donation and surrogacy was legalized in the country after the Government of India appointed Indian Council of Medical Research (ICMR) to form the decree to sketch legal issues and ethical considerations surrounding the infertility treatments. The practice of donation, creating of embryos outside the body and storage that was derived more than a decade ago revolves around some Ethical Considerations and Legal Issues and Chapter 3 of ICMR defines the Code of Practice for infertility treatment. Pahlajani IVF Clinic strictly follows the norms defined by ICMR and preserves the rights of donors under the law.

Throughout the egg donation process, Pahlajani IVF Clinic ensures confidentiality of both donor and recipient. Under the legal agreement of the hospital, the identities are veiled, unless unusual circumstances of medical emergency or orders of court. Secondly, the donors are kept abreast of the legal, ethnic and risks involved in the procedure. The donors are informed beforehand that the offspring (if any) will not know her identity. Also, the recipients are au fait on the limitations tagged with the proposed treatment, techniques and possible side-effects.  

Pahlajani IVF Clinic encourages no treatment without the consent of infertile couple throughout the stages of treatment via a standard consent form to be filed before the process. Before initiation of any kind of process, the donors are serviced with thorough counseling sessions to ensure psychological involvement, balanced decision and push the degree of positivity to higher levels. In case, the donated eggs are used for research purpose, the projects are first approved by the Institutional Ethics Committee.

Criterion to be an egg donor with Pahlajani IVF Clinic

There are few requirements that an egg donor should meet, including, the age criteria that should be between 21 and 35 years. The girl/woman should be free from HIV, Hepatitis B and C, Hypertension, Diabetes, sexually transmitted diseases, and common genetic disorders such as thalassemia. Secondly, the hospital records and determines the blood group and the Rh status, and other relevant information in respect of the donor, such as height, weight, age, educational qualifications, profession, colour of the skin and the eyes, and the family background in respect of history of any familial disorder.

Pahlajani IVF Clinic protects the anonymity of the donor except the child demands the information after becoming an adult. Also, the donor shall have no parental right or duties in relation to the child.Ethical ramifications gyrating around gamete donation sometimes creates a vacuum in fertility treatment. While donors are concerned about autonomy, justice, beneficence, and non-maleficence, the recipients need assurance of the clinical reproduction service. However, Pahlajani IVF Clinic believes in informed decision making and conserves the interests of the donors. 

Pahlajani IVF Clinic walks on few defined principles of ensure health benefit and preventing harm to donors. Donors are well-versed about the longitudinal effects of the ovulation drugs and recoil of the process. 

Dr Neeraj Pahlajani

Egg Donation Programmes at Pahlajani Test Tube Baby Center

Egg donation is a marvel of creating lives through modern technology. Considering the need of few women, who are unable to produce their own eggs or do not want their genetic conditions to pass on to their children, Pahlajani Test Tube Baby Center has been organizing several egg donation camps in Raipur.

It is important to donate eggs as some women, who are unable to produce their own eggs require donations for healthy pregnancy. Multiplicities of reasons are attached to infertility and requirement of donated eggs. Some women might have gone through the menopause early – as young as 20, few women are left infertile after chemotherapy or radiotherapy for cancer, while other women have genetic conditions that resist to be transferred to their offspring.

During the egg donation camp organized at Pahlajani Pregnancy Care, the donors are provided the medical care throughout the process to diminish the risk involved in the process. Eggs of women usually between 21 to 35 years of age are accepted. In the standard egg donation process, the donors might be prescribed a medication for one or more weeks to temporarily halt ovaries' normal functioning to ensure controlled response to fertility drugs.

The egg donation procedure aims to obtain several mature eggs through egg stimulation procedure. The process of stimulating the ovary to produce more eggs than normal is called ‘hyperstimulation’. Donors are suggested to abstain from intercourse or use contraception during the donation cycle to avoid pregnancy with sometimes twins, triplets or quadruplets. The donors need to undergo frequent blood tests and ultrasounds to monitor the periodical development of eggs in response to the hormones. The eggs are removed from the ovaries through minor surgical procedure called transvaginal ovarian aspiration. Hence, the donated eggs are transferred into recipient for in vitro fertilization (IVF). The extracted eggs are first incubated then used in IVF or frozen to be used later.

It is important to for a donor to know that the eggs may go to more than one recipient. Also, one or more women may conceive or no pregnancies may occur. Sometimes, the donated embryos are used by another couple, or used for research, or are left frozen indefinitely. It depends on the need of the situation. At Pahlajani Pregnancy Care, the donors are given medical assistance since the inception of donation cycle. Along with the medical assurances, the donors are helped to ease their inhibitions related to the process. Till date, several donors have donated the gift of parenthood to childless couples through their eggs. 

Dr Neeraj Pahlajani     

Are you too old to get pregnant?

Gradient in the age and fertility graph of a woman takes steep rise during mid-20s and steady decline with approaching late-30s. Before a woman actually starts considering idea of getting pregnant, it sometimes is too late. A woman’s fertility clock starts ticking at its strongest pace, when she hits puberty and it gradually declines much earlier than thought. Although, the male fertility declines leisurely, but for couples with huge age difference face trouble when a partner five years older or more as sperm quality declines with age.

The most fertile time of a woman is between the ages of 19 to 26-years, as the chances of conceiving two days before ovulation are 50 per cent higher. With time, women become 10 per cent less fertile at 27 and the fertility rate starts sharply declining in the mid-30s. Sometimes, a late decision leaves a vast barren ground of infertility before the couples. However, most of the women were seen giving birth to a healthy baby at 35 without real complications in conceiving but after 35 the proportion of women experiencing infertility or miscarriage increases as the rate of fertility drops by nearly 40 per cent between the age of 27 and 34.

After 35, the fertility rate starts depending on the ages of both the partners. If the age difference is less, then two out of five women conceive with 30 per cent chances but couples with larger age difference experience infertility issues as the chances of conceiving remains less than 20 per cent. It is not that women stop conceiving, it just takes longer time and more complications. By the age of 40 only two in five of those who wish to have a baby will be able to do so.

On the other hand, male fertility starts declining at the age of 35. Many men remain fertile into their 50s and beyond, the proportion of men with sperm disorders increases with age. The decline in male fertility is more gradual for men than women. The decline in male fertility can affect the health of the children they may go on to have. Men can remain fertile for much longer than women. Even though male fertility also declines with age, it tends to happen gradually for men.

The reason behind decline of fertility in women is considered as ovulation problem and blockages to the fallopian tubes. When a woman hits 30s, she is left with less number of quality eggs that makes her ovarian reserve decline. And with the approach of menopause that comes usually around 40s, women are left with meager number of eggs. In fact, the chances of conceiving non-identical twins are seen mostly in older women. This is because the struggles to produce more Follicle Stimulating Hormone (FSH) to make women ovulate at the older age. The hormone is called follicle. Body produces FSH to fight the fewer viable eggs left in your ovaries. But the over-production of FSH can result in more than one follicle ripening and releasing an egg and multiply pregnancies.

However, with advancement of technologies, the couple need not worry. The upward trend of IVF has preserved the excitement of couples wanting have babies at any age. It is suggested to see a doctor after the age after regular failed attempts of getting pregnant.

Dr Neeraj Pahlajani

Medical Tourism – No more a Taboo in Raipur

Even as the institutions like IIM and AIIMS has anointed Raipur among one of the rapidly developing cities in country, the burgeoning idea of medical tourism parallelly has caught the imagination fertility tourists living in geographically dispersed cities towards the state.

Away from the cacophony of fast moving metropolitans, Raipur is situated in the heart of Chhattisgarh, a tribal heartland in Central India. With rare combination of state-of-the-art medical infrastructure and potential IVF and surrogacy options in Raipur, it has gradually fueled the international demand. Raipur can be termed as a bastion for couples wanting to ply their gametes at cheaper rates. With low traffic frequency rates, uber medicinal and infrastructural at hospitals, Raipur has become one of the favorite destinations for foreigners wanting to undergo fertility treatment.

It was observed that medical tourists were more liberal than ever for undergoing treatment in Raipur, after several infertile couples from USA, Europe, Africa and even neighboring countries like Bangladesh and Afghanistan came here it to find the cure. Success stories of the IVF and surrogacy in Raipur has put the doubts of couples to rest, who are otherwise skeptical about the treatment because of the obvious complications associated to it. Also, the cheap IVF treatment offered in Raipur has warded off the discomfort of pocket burning fees demanded in the first world countries. Visit counts of tourists tripping Raipur has multiplied in past one decade, with most of them returning with assured pregnancy results. The city has won an international recognition after high ratio of infertile couples was blessed with children.

The day commercial surrogacy was declared legal in India it also opened the flood gates of all the inhibitions related to surrogacy and IVF in the country. After facing a tough rebound from less liberal countries, medical tourism has emerged as a successful intersection of inexpensive and medical infrastructure in Raipur. In years, the city has witnessed high influx of tourists seeking medical care willing to travel the tribal land. Skewed population distribution in metros, and commercialized health care has locomoted the infertile tourists towards Raipur. The infertility hospitals have been able to preserve their appeals for assuring best treatment to patients. A taboo associated with IVF and surrogacy is dying a fast death after Raipur was appended to the list of best known IVF and surrogacy destinations.

Dr Neeraj Pahlajani

Medical Tourism In India

With India becoming a mecca for infertile couples, medical tourism has clearly laid an offshore pipeline for the global fertility tourists to fish for cut-price generic material from country’s pool. Though, medical tourism stumbles onto few legal and ethical obstacles in many countries like Canada, France and UK, where laws and statutes cover the legal issues of fertility treatment. 

In India, without real ethnic or legal implications, medical tourism has opened new avenues for couples seeking IVF treatment in pocket friendly rates. Couples wanting to undergo IVF treatment tend to churn out leads from internet to get best, assured and cheap fertility help. India, with its fascinating culture, also has impressive IVF with less than lesser implications and more chances of fertility. Beyond border quest for babies has globalised the surgical procedures, giving multiplicity of options to infertile couples before actually undergoing the life changing procedure.

While some countries have shortage of women donors, some actually restrict the doctors with legal implications. However, the scenario is rather more flexible in India. With higher rate of IVF successes, India has ace on its sleeves to have magnified its presence on world map. Easing the paramount concerns of infertile couples, hassle-free treatment and more chances of getting pregnant has anointed the country as one of the favorite destinations for medical tourism. Also to add, commercial surrogacy is completely legal in India, increasing international confidence on the country for treatment. It is one of those countries where legal issues around fertility treatment are left to official guidelines. For example, many countries have strict single embryo transfer policies, while in India will leave the number of embryos implanted up to the discretion of the fertility specialist. Where implantation of single embryos dims the chances of conceiving, it also reduces faith on the entire procedure. 

Apart from legal regulations, the fragile cord of ethnic inference has rarely affected the surrogacy procedure as anonymity of the donor is maintained. Boasting its large pool of skilled doctors and low treatment prices, healthcare balances the global brain drain of IT and medicine. Medical tourism has clearly shrunk the borders and brought countries closer to resolve medical issues over a wider spectrum.

With population of humongous proportion, need of availability, accessibility and affordability to reduce exacerbating health insecurity would be the pressing concern in few decades. However, the IVF successes have seeded the hope of infertile couples to experience the bliss of parenthood, with such procedures becoming bold predictions of reckoning.

Dr Neeraj Pahlajani

Dr.Malpani's Blog: How do I interpret my ovarian reserve test results ?

Dr.Malpani's Blog: How do I interpret my ovarian reserve test results ?

The Evaluation of Unexplained Infertility

An infertility evaluation is usually initiated after one year of regular unprotected intercourse in women under age 35 and after six months of unprotected intercourse in women age 35 and older. However, the evaluation may be initiated sooner in women with irregular menstrual cycles or known risk factors for infertility, such as Endometriosis, Tubal Disease, Premature Ovarian Aging, Immunological Infertility, a history of pelvic inflammatory disease, or reproductive tract malformations.

The basic evaluation can be performed by an interested and experienced primary care physician or an obstetrician-gynecologist. The primary care physician generally should refer the patient to a specialist for treatment of infertility. Many gynecologists initiate treatment prior to referral to a reproductive endocrinologist. This decision depends upon the results of infertility tests and clinician experience.

Multiple tests have been proposed for evaluation of female infertility. Some of these tests are supported by good evidence, while others are not. This topic will provide an evidence-based approach to the evaluation of female infertility. The etiology and treatment of female infertility, as well as the etiology, evaluation, and treatment of male infertility

Over the past decade, significant advances have occurred in the diagnosis and treatment of reproductive disorders. In this review, we discuss the routine testing performed to diagnose unexplained infertility. We also discuss additional testing, such as assessment of ovarian reserve, and the potential role of laparoscopy in the complete workup of unexplained infertility. Finally, we outline the available therapeutic options and discuss the efficacy and the cost-effectiveness of the existing treatment modalities. The optimal treatment strategy needs to be based on individual patient characteristics such as age, treatment efficacy, side-effect profile, and cost considerations.

Both partners of an infertile couple should be evaluated for factors that could be impairing fertility. The infertility specialist then uses this information to counsel the couple about the possible etiologies of their infertility and to offer a treatment plan targeted to their specific needs. It is important to remember that the couple may have multiple factors contributing to their infertility; therefore, a complete initial diagnostic evaluation should be performed to detect the most common causes of infertility, if present. When applicable, evaluation of both partners is performed concurrently. The recognition, evaluation, and treatment of infertility are stressful for most couples. The clinician should not ignore the couple's emotional state, which may include depression, anger, anxiety, and marital discord. Information should be supportive and informative.

Significant advances have occurred in the diagnosis and, more importantly, in the treatment of reproductive disorders over the past decade. The overall incidence of infertility has remained stable; however, the success rates have markedly improved with the widespread use of assisted reproductive technologies. Treatment options and success vary with the cause of infertility. Approximately 15% to 30% of couples will be diagnosed with unexplained infertility after their diagnostic workup.

Infertility is customarily defined as the inability to conceive after 1 year of regular unprotected intercourse. The infertility evaluation is typically initiated after 1 year of trying to conceive, but in couples with advanced female age (> 35 years), most practitioners initiate diagnostic evaluation after an inability to conceive for 6 months. The Practice Committee of the American Society for Reproductive

History and physical examination and Diagnostic tests - Findings on history and physical examination and Diagnostic tests may suggest the cause of infertility and thus help focus the diagnostic evaluation.

Important History points:

·         Duration of infertility and results of previous evaluation and therapy.

·         Menstrual history (cycle length and characteristics), which helps in determining ovulatory status. For example, regular monthly cycles with molimina (breast tenderness, ovulatory pain, bloating) suggest the patient is ovulatory and characteristics such as severe dysmenorrhea suggest endometriosis.

·         Medical, surgical, and gynecological history (including sexually transmitted infections, pelvic inflammatory disease, and treatment of abnormal Pap smears) to look for conditions, procedures, or medications potentially associated with infertility. At a minimum, the review of systems should determine whether the patient has symptoms of thyroid disease, galactorrhea, hirsutism, pelvic or abdominal pain, dysmenorrhea, or dyspareunia. Young women who have undergone unilateral oophorectomy generally do not have reduced fertility since young women have many primordial follicles per ovary; however, prior unilateral oophorectomy may impact fertility in older women as they may develop diminished ovarian reserve sooner than women with two ovaries.

·         Obstetrical history to assess for events potentially associated with subsequent infertility or adverse outcome in a future pregnancy.

·         Sexual history, including sexual dysfunction and frequency of coitus. Infrequent or ineffective coitus can be an explanation for infertility.

·         Family history, including family members with infertility, birth defects, genetic mutations, or mental retardation. Women with fragile X premutation may develop premature ovarian failure, while males may have learning problems, developmental delay, or autistic features.

·         Personal and lifestyle history including age, occupation, exercise, stress, dieting/changes in weight, smoking, and alcohol use, all of which can affect fertility.

Physical Examination:

·         The physical examination should assess for signs of potential causes of infertility. The patient's body mass index (BMI) should be calculated and fat distribution noted, as extremes of BMI are associated with reduced fertility and abdominal obesity is associated with insulin resistance.

·         Incomplete development of secondary sexual characteristics is a sign of hypogonadotropic hypogonadism. A body habitus that is short and stocky, with a squarely shaped chest, suggests Turner syndrome.

·         Abnormalities of the thyroid gland, galactorrhea, or signs of androgen excess (hirsutism, acne, male pattern baldness, virilization) suggest the presence of an endocrinopathy (eg, hyper- or hypothyroidism, hyperprolactinemia, polycystic ovary syndrome, adrenal disorder).

·         Tenderness or masses in the adnexae or posterior cul-de-sac (pouch of Douglas) are consistent with chronic pelvic inflammatory disease or endometriosis. Palpable tender nodules in the posterior cul-de-sac, uterosacral ligaments, or rectovaginal septum are additional signs of endometriosis.

·         Vaginal/cervical structural abnormalities or discharge suggest the presence of a müllerian anomaly, infection, or cervical factor.

·         Uterine enlargement, irregularity or lacks of mobility are signs of a uterine anomaly, leiomyoma, endometriosis, or pelvic adhesive disease.

·         Pathogenesis, clinical features, and diagnosis of endometriosis

·         Clinical features and diagnosis of pelvic inflammatory disease

·         Clinical manifestations and diagnosis of congenital anomalies of the uterus

·         Clinical manifestations and diagnosis of hyperprolactinemia

·         Diagnosis of and screening for hypothyroidism in nonpregnant adults

·         Diagnosis of hyperthyroidism

·         Clinical manifestations of polycystic ovary syndrome in adults

·         Clinical manifestations and diagnosis of Turner syndrome (gonadal dysgenesis)

·         Epidemiology, clinical manifestations, diagnosis, and natural history of uterine leiomyomas (fibroids)

Diagnostic Tests:

In addition to the history and physical examination, the initial diagnostic evaluation consists of:

·         Semen analysis to detect male factor infertility.

·         Documentation of normal ovulatory function. Women with regular menses approximately every four weeks with moliminal symptoms are almost always ovulatory.

·         A test to rule out tubal occlusion. We usually perform a hysterosalpingogram (HSG), but laparoscopy with chromotubation may be more appropriate in women suspected of having endometriosis. Indigo carmine can be used for the chromotubation dye.

Risk factors noted from the couple's history may indicate the need for additional testing after the initial infertility evaluation. When the results of a standard infertility evaluation are normal, practitioners assign a diagnosis of unexplained infertility. Although estimates vary, the likelihood that all such test results for an infertile couple are normal that the couple has unexplained infertility is approximately 15% to 30%.

A thorough but time-efficient investigation of the infertile couple is required prior to a diagnosis of unexplained infertility. Couples should undergo a semen analysis, ovulation testing, assessment of ovarian reserve, and imaging to assess for tubal and uterine factors before a diagnosis of unexplained infertility is made. This workup can be completed within 1 menstrual cycle. In the couples with unexplained infertility, various treatment modalities are available, including expectant management with lifestyle changes, operative laparoscopy, COH (clomiphene citrate or gonadotropins) with IUI, and IVF (with or without ICSI). The optimal treatment strategy needs to be based on individual patient characteristics such as age, treatment efficacy, side-effect profile such as multiple pregnancy, and cost considerations.

·         Couples should undergo a semen analysis, ovulation testing, assessment of ovarian reserve, and imaging to assess for tubal and uterine factors before a diagnosis of unexplained infertility is made.

·         The principal treatments for unexplained infertility include expectant observation with timed intercourse and lifestyle changes, clomiphene citrate and intrauterine insemination (IUI), controlled ovarian hyper stimulation with IUI, and in vitro fertilization (IVF).

·         Although expectant management is associated with the lowest cost, it results in the lowest cycle fecundity rates. It may provide an option for a couple with unexplained infertility in whom the female partner is young and the problem of oocyte depletion is not an immediate concern.

·         The most expensive, but also most successful treatment of unexplained infertility consists of the spectrum of assisted reproductive technology including IVF, with or without intracytoplasmic sperm injection. IVF is the treatment of choice for unexplained infertility when the less costly, but also less successful treatment modalities have failed.

·         The optimal treatment strategy needs to be based on individual patient characteristics such as age, treatment efficacy, side-effect profile such as multiple pregnancy, and cost considerations.