الفهرس 
Unexplained InfertilityOnly 14 pages are availabe for public view
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Abstract
I
n fact there is no consensus on which factors we should diagnose unexplained infertility, most of gynecologists diagnose it after evaluation of male partner by semen analysis and female partner by history, hormonal profile (FSH, LH, TSH and PRL) and tubal patency by HSG, hysteroscopy and or laparoscopy.
There is controversy regarding treatment of unexplained infertility due to absence of specific pathophysiological rational which allows curative intervention.
The main three lines of treatment of such cases are controlled ovarian hyperstimulation (to increase chances of pregnancy), IUI with spontaneous or induced ovulation and third is IVF.
Some non-PCOs infertile women including those with unexplained infertility are associated with insulin resistance due to aging (paolisso G et al., 1999), stress (Vanltallie TB et al., 2002), depression (Wolkowitz OM et al., 2001), obesity(Bjorntorp P et al., 2000) and sedentary life style (Rosenthal M et al., 1983). That’s why metformin as an insulin sensitizer drug may has benefit in such cases.
Metformin side effects includes gastrointestinal irritation and vitamin B12 deficiency with long term use, while regarding pregnancy there is no clear evidence suggest increasing congenital anomaly with metformin use.
The use of metformin during all parts of pregnancy is controversial.
The objective of this study is to evaluate the effect of metformin on clinical pregnancy rate in women with unexplained infertility.
The current study is prospective randomized controlled trial study, it was conducted on 170 women with unexplained infertility who were recruited from infertility clinic in Ain Shams Maternity Hospital after they have received information on the purpose and course of the study from medical investigator and had provided a written informed consent.
The 170 participants were divided into two equal groups with simple random distribution technique.
• group A:this is the case group, it includes 85 cases who received metformin plus clomiphene citrate
• group B: this is the control group; it includes 85 control who received placebo plus clomiphene citrate.
• Intervention
Metformin 850 mg tablets was started twice daily started immediately at booking time and continued with the induction protocol, it was stopped once pregnancy was confirmed.
• Ovulation induction protocol:
Clomiphene citrate (100mg) was started on day2 till day6 of the cycle.
Transvaginal ultrasound was done for all in day 2 to exclude presence of ovarian cyst and to identify normal appearance of ovaries, then folliculometry on day 9 followed by serial folliculometry every other day till reaching dominant follicle 18mm or more where HCG of 10000 IU intramuscular injection was administrated, then timed sexual intercourse was instructed 36-48 hr. after HCG injection and for next 3 days.
Serum pregnancy test was done after 16 days.
Transvaginal ultrasound was done on day 35 for women with positive pregnancy test.
There were no statistically significant differences between women of both groups regarding age, body mass index, parity, number of abortions, duration or type of infertility.
There was no statistically significant difference between women of both groups regarding basal FSH and LH levels.
There was no significant differences were found between both groups regarding the number of dominant follicles produced during induction of ovulation with clomiphene citrate. While, endometrial thickness was statistically significantly larger with metformin adjuvant treatment during clomiphene citrate induction of ovulation (8.84±0.85) compared to (7.59±0.75) in clomiphene only group.
Incidence of clinical pregnancy was not statistically significantly different between both groups. Analysis of relative incidence of clinical pregnancy revealed marked inconsistency on examining the 95% confidence interval; i.e. ranging from 0.83 to 1.06. The number needed to treat (NNT) was estimated to be 21.25; meaning about 21 women with unexplained infertility should receive adjuvant metformin treatment during clomiphene citrate induction of ovulation, so that one extra women achieve clinical pregnancy.
Also, no statistically significant differences were found between both groups regarding the incidence of complications of ovulation induction, namely multiple pregnancy, ovarian cyst and ovarian hyperstimulation syndrome.
In conclusion our study showed little benefit was added to the patients by using metformin as adjuvant therapy to clomiphene citrate during ovulation induction as 21 women are needed to be treated with metformin to get one more pregnant woman.