Despite the advances in assisted conception, female infertility remains one of the major challenges for intrauterine (artificial) insemination and in-vitro-fertilisation.
A study conducted by Drs. Narendra Malhotra and Jaideep Malhotra on 55 patients who have problem of infertility shows significant improvement in pregnancy rate when M2-Tone was given prior to artificial insemination (also known as IUI protocol).
The physicians reckon that the problem of female infertility is about 10-15 per cent, and the majority of couples opt for IUI and IVF.
While they do not discountenance any choice that couples may opt for, the physicians’ research on Ayurveda — the ancient Indian medical science — has identified four requisites for normal healthy pregnancy. They are: the season (resembling normal ovarian steroid-dependant status), the good quality viable seeds (resembling healthy sperm and ovum), the fertile soil (healthy and conducive endometrial structure) and the water (resembling normal endometrial vasculature). “Poor quality of any of these four essentials leads to infertility,” the doctors say.
M2-Tone, an herbal medicine by Charak Pharma Private Ltd., a Mumbai-based drug manufacturing company, has established its estrogenic effect in female infertility through various studies conducted in the past.
A preliminary study on the effects of M2-Tone in the treatment of infertility shows its effect on the increase in weight and glycogen content of the uterus. In order to arrive at a genuine conclusion, the researchers compared the efficacy of M2-Tone with low dose aspirin and an antioxidant as a supplement in IVF cycles for poor responders. The results of the study demonstrated the advantage of M2-Tone over the others as far as implantation rates and live birth rates were concerned.
The researchers say that a clinical trial showed that M2-Tone stimulates ovulation in females who have problems with their ovulation. After a clinical evaluation, the researchers reported that M2-Tone achieved a very good rate of conception in infertility.
In an earlier clinical trial by another set of researchers led by Dr. Malhotra, M2-Tone showed significant increase in pregnancy rate.
The researchers conclude: “Thus, M2-Tone has shown its beneficial effects on the three pre-requisites (menstruation, ovum, endometrium) for conception.”
Again, they hypothesise that adding M2-Tone prior to artificial insemination can promote normal endometrial proliferation, perfusion and improve endometrial receptivity for better implantation in the subjects.
Before initiating the study, all patients were given a three-month ‘wash–out’ period. After that, the patients were evaluated in one natural cycle for their hormonal levels. After overnight fasting, the peripheral blood was obtained and analysed for plasma oestradiol and plasma progesterone levels, using radioimmunoassay. These readings were considered as baseline hormonal parameters.
All the patients were given either M2-Tone tablets or identical placebo for the next three months prior to artificial insemination. Patients were randomly assigned to two different groups — one group received two tablets of M2-Tone twice daily for three months; while and the other group received an identical placebo therapy on similar lines before artificial insemination.
A total of 55 patients undergoing intrauterine (artificial) insemination were divided into two groups. Group 1 of 28 patients was administered two M2-Tone tablets twice a day for three months prior to intrauterine (artificial) insemination. Group 2 of 27 patients was given identical placebo in the similar fashion.
Before starting the study baseline, oestradiol and progesterone levels of all the patients were evaluated in their natural cycle. During the ovarian stimulation regimen, the patients were submitted to hormonal (oestradiol and progesterone) and 3D Colour Doppler (endometrial thickness, uterine arteries) evaluations.
Out of a total 55 patients, only 50 patients completed the study. In M2-Tone group, endometrial thickness increased to mean 8.65 mm from 4.6 mm at baseline (day 2 of menstrual cycle); whereas in placebo group, it rose to mean 6.89 mm from 4.8 mm at baseline.
The uterine score in the M2-Tone group increased significantly from 3.15 to 13.31 and from 3.16 to 10.08 in placebo group. There was corresponding increase in pregnancy rate in the M2-Tone group (30.77 per cent), as compared to the placebo group (16.66 per cent).
In all, the researchers say, M2-Tone has shown better endometrial thickness and endometrial layering, among others.
“M2-Tone as a supplement treatment in artificial insemination shows significant improvement in pregnancy rate. None of the patients reported any adverse effects,” the doctors conclude.
The researchers say that certain categories of people were not included in the study, and these include obese women.
Indeed, a Professor of Reproductive Endocrinology who also pioneered in-vitro fertilisation in Black Africa, Prof. Oladapo Ashiru, advises women who want to undergo fertility treatment to first embark on weight-shedding programme before they do.
He says this becomes necessary in view of the fact that if the physician commences fertility treatment on an obese woman, the drugs will just be disappearing into fatty cells, with the attendant frustration for the woman and her doctor, in addition to possible side effects.
In this regard, the scientific nature of M2-Tone is not in doubt.
While M2-Tone is used in the treatment of female infertility, Addyzoa, a formulation of various active ingredients of naturally occurring plants, is used for the functional competence of spermatozoa in selected patients with male factor infertility.
Major emphasis was placed on the motion, characteristics, production and DNA integrity of sperms, among others, before and after intake of Addyzoa.
The researchers say efforts were taken to establish the normal value of the sperm parameters in a relatively large group of selected volunteers with proven fertility.
Thirty-six patients with various conditions that were responsible for their infertility were selected, while 20 proven fertile donors (Group III) were included in the study.
The researchers performed semen analysis on the subjects, using the World Health Organisation guidelines, and all sorts of abnormalities were studied, using computer assisted semen analysis (CASA).
Addyzoa was administered on the subjects for three consecutive months. The researchers conclude that Addyzoa was administered on the subjects for three consecutive months. The researchers conclude that Addyzoa improved the functional properties of sperm, boosting the men’s fertility.
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