Improving
pregnancy rates by means of polarized maca based phytoterapy and intratubal
insemination
pubblicato in Controversies in Obstetrics Gynecology & Infertility,
september 2001
G. Menaldo, S. Serrano, B. Lopez
Institute
of Reproductive Medicine and Psychosomatic Gynaecology(S.Carlo-Ipog),
Turin Centre of Research on Medical Bioclimatology-Biotechnologies-Natural
Medicine, Milan State University
e-mail: sancarlo@ interlink.it
Summary
This
prospective randomized study aimed at assessing whether Andean phytotherapy
based on polarized Maca (Lepidium Meyenii Walp), combined with low-dose
recombinant FSH, may improve pregnancy rates in an intrauterine insemination
(ITI) programme. To this end, two homogeneous groups, including 63 selected
couples each, were compared. In group A, without Andean phytotherapy,
13 pregnancies were recorded, i.e. 11.8% per cycle, with a 20.63% global
pregnancy rate after 4 attempts. In group B (polarized Maca+ recombi nant
FSH), 35 pregnancies were recorded, (26.51% per cycle), with 55% global
pregnancy rate after 4 attempts. The difference between both was statistically
significant (p < 0.001).
Introdution
In
the last few years Maca, a perennial plant of the lepidium meyenii walp
peruvanum species, was studied in our Institute for its polyendocrine
value and for its balanced mineral content, both particularly fit for
use in adjusting cycle-related hormone imbalance and in reproductive medicine.
(1,2).Early research on the botanical, phytochemical, and pharmacological
properties of this plant includes the studies by Gloria Chacon, that started
in 1960 and were published on Peru's biology review in 1990(3). The authoress
demonstrated, in a study carried out on rats inoculated with alkaloids
obtained from maca, the regulating and stimulating action of the active
ingredients contained in the maca's tuberous root on samples of rat testes
and ovaries. Laboratory tests clearly highlighted a stimulation of ovarian
follicles and an increased thickness of the endometrium in female rats,
as well as an increased number and motility of sperms in male rats. (4).
R. Aquino, V. De Leo, F. De Simone, and colleagues believe that the sterol
fraction is mainly constituted by systosterol (45.5%), campesterol (27.3%),
and ergosterol (13.7%) (5). The high mineral contents of maca is rather
interesting: calcium, iron, magnesium, copper, iodine, silicon, phosphor,
potassium, as well as manganese and zinc are found in ideal proportions,
that are especially important for man reproduction (Table 1). The root
also contains a high concentration of laevulose and fructose, which are
known to occur in semen as an energy source for the sperms.The lepidium
meyenii root contains aromatic isothiocyanates which demonstrated in various
studies their power to increase libido both in animals and in man. (6).Our
centre's case history includes a growing number of infertile couples,
rather reluctant to submit to stimulation cycles with high-dose gonadotrophins,
due to a fear of multiple pregnancies, as well as to the possible side
effects related to ovary hyperstimulation. Indeed, non-customized stimulation
protocols, often inadequate, have increased multiple pregnancy rates too
much (20 to 30%), which is unacceptable both in terms of increased hyperstimulation
risk and of pregnancy and perinatal risks related to the multiple number
of foetuses. Frequent news about multiple pregnancies have caused alarm
in public opinion as well as among specialists. Thus a growing consensus
is recorded for moderate stimulation, especially within the framework
of insemination techniques. The prospective randomized study described
in this paper goes along this line with the aim of establishing whether
Andean phytotherapy (polarized maca) combined with low-dose gonadotrophins,
may improve pregnancy rates in an insemination programme based on intratubal
insemination (ITI) techniques.
Materials
and methods
From
January 1999 to January 2001 we treated a sample of 126 couples, suffering
from infertility problems for over 3 years, with 242 intratubal insemination
(ITI) cycles. First, infertility was precisely diagnosed through laboratory,
microbiological, and clinical tests on both partners. Such tests included
for women a hormone assay, a post-coital test, vaginal ultrasound scanning,
vaginal and cervical swabs with antibiogram, hysterosalpingogra phy, as
well as hysteroscopy and laparoscopy in uncertain cases. Male partners
were submitted to spermiogram, sperm-culture, mar test, and hormone assay,
when necessary. Couples with the following causes of infertility were
included in the homologous intratubal insemination programme, upon giving
their consent: cervical factor, ovarian factor, unilateral tubal factor,
hypogonadotropic hypogonadism, idiopathic infertility, low to moderate
male factor with Swim up test > 4 million/ml mobile forms.
Female patients were aged 27 to 39 (mean age 34). As for ovulation induction
modes, the patients were divided into two groups:
Group A: induction with recombinant gonadotrophins only (FSH 100 IU from
day 3 to day 4 of the cycle; FSH 75 IU from day 5 to the day before intake
of 7000 IU of HCG).
Group B: induction with phytotherapy based on polarised maca (LMWP Zener
100-mg tablets: 3tablets daily from day 2 of the cycle to the day of intake
of 7000 IU of HCG.From day 3 of the cycle, recombinant gonadotrophins
(same as for group A) until the day before intake of 7000 IU of HCG).
Lepidium meyenii (Maca) was administered as 100 mg capsules polarized
with 634.7-nm electromagnetic radiation. Such polarization, matching with
the DNA resonance polarization, promotes the prompt recognition and use
of the substance by the body (the function of the body's electromagnetic
receptors is enabled and enhanced by the 634.7-nm radiation). The polarized
form allows the intake of very low quantities of the plant to produce
a significant biological effect within a short time (7). Administration
to women starting from day 2 of the cycle, improves follicle recruitment,
while the intake of 3 100 mg tablets per day in men was extended for 90
days for Group B only, in order to improve the fertilising power of sperms.
As to the randomization method, women of group A or group B were selected
at random on the day of definition of the treatment plan according to
the even or odd series number. Starting from day 8 of the cycle, stimulation
was monitored by means of blood oestradiol assay and follicular monitoring
(Table 2).7000 IU HCG were administered when the largest follicle reached
a diameter > 18-20 mm. Insemination was performed 35-36 hours after
HCG administration with the intratubal insemination technique. This provides
for gamete transfer directly to the tubal lumen through the transcervical-uterine
upgoing tract. Semen priming and capacitation were performed by means
of two combined methods: 1 ml of semen by Swim up; the remaining portion
by 3 gradients of 45%, 70%, and 95% Pure sperme.
Results
The
126 infertile couples recruited for this prospective randomised study
were globally submitted to 242 cycles divided as follows: group A 110
cycles; group B 132 cycles. Both groups were homogeneous by age, term
of infertility, and semen parameters. The highest success rate was achieved
in group B (polarized Maca + recombinant FSH), with 35 pregnancies equal
to 26.51% per cycle, and a 55.50% pregnancy rate after 4 attempts (Table
3). In group A (recombinant FSH) that did not receive phytotherapy, 13
pregnancies were recorded, equal to 11.18 per cycle, with a 20.63% pregnancy
rate after 4 cycles. The difference between both groups in terms of per-cycle
pregnancy rate and global pregnancy rate (after 4 cycles) is statistically
significant (p < 0.001).
One spontaneous miscarriage occurred in group A at week 8 and one spontaneous
miscarriage occurred in group B at week 7. While no twin pregnancies were
recorded in group A, two pregnancies started in group B with 2 ovum chambers,
which spontaneously developed into single pregnancies.
Conclusions
In
conclusion, the use of Lepidium meyenii in the form of polarized maca,
significantly improves pregnancy rates when combined (Group B) with low-dose
gonadotrophins. One of the main factors, in our opinion, is the LH-like
action performed through the release and control of both gonadotrophins
(FSH, LH). Indeed, a good follicle genesis and steroid genesis resulting
into the maturation of quality oocytes requires the combined action of
the follicle-stimulating hormone (FSH) and of the luteinising hormone
(LH). The latter was recently reinstated by the scientific community,
which understood its great importance at very low doses ever since last
generation recombinant gonadotrophins were totally deprived of it. (8,9)
This small LH quantity secreted by the hypophysis in ideal doses thanks
to the hypothalamic action of Lepidium, probably determines the improved
quality of oocytes, which are thus more fit for fertilisation and implant.
A study by Delphine P. Levy and colleagues (10) supports the theory of
two cells, two gonadotrophins; a minimum LH activity is deemed vital for
optimal development of the follicle-oocyte set during induction of ovulation,
and she thus concludes that a small LH fraction should be included in
each type of stimulation protocol. We finally report the recent conclusions
drawn by the Filicori group (9). Based on physiological data and test
results, they demonstrated that a supplemental LH activity reduces the
duration of stimulation, the total quantity of hormone intake and, consequently,
the cost of the process. It may further positively influence the quality
of oocytes and reduce the risk of ovarian hyperstimultion. Our Group had
come to similar conclusions in some prior studies (1,2) ever since 1996.
In summary, the results of this study on the treatment of infertility
in couples point out to intratubal insemination, combined with ovary stimulation
with low-dose recombinant FSH and polarized maca intake, as an effective
method, well tolerated by the couples, and virtually free of side effects
when at least one of the tubes has a regular function and the male factor
is low to moderate (Swim up test > 4 million /ml mobile forms). In
addition, the mineral content of maca, well balanced and significant,
is ideal for infertility problems, because manganese, calcium, and zinc
are available in the correct proportions. Zinc is also vital to protect
the sperm nucleus from premature decondensation. Hence the importance
of administering polarised maca to male partners too.
References
1.
Menaldo G. La medicina globale negli squilibri ormonali e nella fertilità.Atti
del terzo convegno internazionale: Scienze Mediche Integrate, dic 2-10,
1996-Università di Milano.
2. Menaldo G. Ossigeno allotropico e Lepidium Meyeneii (LMWP) nel trattamento
dell'infertilità. Atti: Giornate di Medicina Naturale, giugno 26-27,1999-
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Chacòn G. La maca ( Lepidium peruvianum) Chacòn sp. Nov.
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Chacòn G. La importancia de Lepidium peruvianum Chacòn (
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LC, Zheng QY. Effect of a lipidic extratact from Lepidium meyenii on sexual
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Table
1. Active ingredients of Lepidium Meyenii ( Maca)
·
Alkaloids: macaine 1,2,3,4
· Phytosterols: -sitosterol (45.5%), campesterol (27.3%), ergosterol
(13.6%), B-ecdysone
· Aromatic isothiocynates: benzyl-isothiocyanate, P-methoxy-benzyl-isothiocynate
· Minerals: calcium, iron, magnesium, zinc, manganese, copper,
silicon, phosphor, iodine, potassium, aluminium, tin, bismuth
· Vitamins: B1, B2, B12, C, E, A
· Carbohydrates: fructose, laevulose
· Unsaturated essential fatty acids: linoleic (32.6%), oleic (11.1%),
arachidonic (1.6%)
· Essential aminoacids: phenylalanine, histidine, isoleucine, leucine,
lysin, methionine, threonine, triptophan, valine.
· Flavonoids, tannins, saponins.
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