|Year : 2018 | Volume
| Issue : 1 | Page : 16-20
Prognostic factors and pregnancy outcome in superovulated intrauterine insemination cycles in North Indian women
Rekha Sachan1, Munna Lal Patel2, Meenakshi Singh3, Pushplata Sachan4
1 Department of Obstetrics and Gynaecology, King George Medical University, Ambedkar Nagar, Uttar Pradesh, India
2 Department of Medicine, King George Medical University, Ambedkar Nagar, Uttar Pradesh, India
3 Department of Obstetrics and Gynaecology, Government Medical College, Ambedkar Nagar, Uttar Pradesh, India
4 Department of Physiology, Career Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
|Date of Web Publication||28-Aug-2019|
Prof. Rekha Sachan
Department of Obstetrics and Gynaecology, King George Medical University, C-28, Sec-J Aliganj, Lucknow - 226 024, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Background: Controlled ovarian hyperstimulation (COH) with intrauterine inseminations (IUI) is a commonly used method to treat infertile couples. This study aimed to evaluate prognostic factors responsible for successful pregnancy outcome in COH and IUI cycles. Materials and Methods: A cross-sectional study was carried out over a period of 1 year. A total of 130 women who visited the department of obstetrics and gynecology for the treatment of infertility were included in the study. Ninety-eight women were enrolled for this study, and proper screening protocol was followed. The outcome of COH-IUI cycles was assessed by evaluating many parameters such as age, duration of infertility, body mass index (BMI), etiology of infertility, endometrial thickness, and number of dominant follicles. Results: The mean age of pregnant women (25.40 ± 3.52 years) was significantly lower compared to nonpregnant women (28.01 ± 3.21 years) (P < 0.005). The mean BMI of pregnant women was 23.00 ± 2.41 kg/m2 whereas the mean BMI of nonpregnant group was 25.12 ± 3.32 kg/m2. This difference was statistically significant. Among pregnant women, 86.7% had bilateral patent fallopian tube and 88% in nonpregnant group had bilateral patent fallopian tube. In not getting pregnant group, the most common cause of infertility was unexplained in 80.7%, anovulatory cycles in 9.6%, and male factor infertility in 9.6%, whereas in pregnant group unexplained causes were found in 93.3% and male factor in 6.7%. No significant difference was observed between the two groups in terms of bilateral fallopian tube patency, antral follicular count, and endometrial thickness on the day of ovulation. There was no difference in pregnancy rates using either double IUI or single IUI. In our study, woman's age, BMI, and single dominant follicle were the main prognostic factors for successful outcome. Conclusions: In our study, woman's age, BMI, and single dominant follicle were the main prognostic factors for successful outcome.
Keywords: Infertility, intrauterine insemination, pregnancy rate, prognostic factors
|How to cite this article:|
Sachan R, Patel ML, Singh M, Sachan P. Prognostic factors and pregnancy outcome in superovulated intrauterine insemination cycles in North Indian women. Afr J Infertil Assist Concept 2018;3:16-20
|How to cite this URL:|
Sachan R, Patel ML, Singh M, Sachan P. Prognostic factors and pregnancy outcome in superovulated intrauterine insemination cycles in North Indian women. Afr J Infertil Assist Concept [serial online] 2018 [cited 2019 Sep 23];3:16-20. Available from: http://www.afrijiac.org/text.asp?2018/3/1/16/265673
| Introduction|| |
Infertility is generally defined as the inability to conceive despite regular and unprotected intercourse for 1 year. Infertility is a rising problem, affecting many couples all over the world and associated with significant impact on the medical, psychosocial, and economic aspects.,
40%–50% infertility is due to female-related causes, which include ovulatory disorders, poor egg quality, endometriosis, tubal damage, and unexplained infertility. Infertile couples can be treated by assisted reproductive technology. Controlled ovarian stimulation in association with intrauterine insemination (IUI) is the first-line treatment option of assisted reproductive technology. It is helpful in male factor infertility, unexplained infertility and infertility due to cervical factor, anovulation, minimal and mild endometriosis. This is a cost-effective, less invasive, and simple method to improve pregnancy rates in couples who are unable to conceive.
During IUI method processed semen sample inserted inside the uterine cavity by a cannula. Successful IUI outcome depends on various prognostic factors, including woman's age, duration of infertility, type of infertility, cause of infertility, follicle number, ovulation protocol, follicular response after stimulation, endometrial thickness, numbers of sperm inseminated, sperm morphology, progressive motile sperm count, and cause of infertility.,
During infertility treatment, every patient is optimistic and many times asked how much chances of successful pregnancy outcome in stimulation induction cycle. Thus, there is a need to evaluate the role of prognostic factor for pregnancy outcome in controlled ovarian hyperstimulation (COH) and IUI cycle. On the basis of knowledge of predictive factor, doctors are able to counsel the couples and determine the chances for successful pregnancy.
| Materials And Methods|| |
A prospective study was carried out in the Department of Obstetrics and Gynaecology, at King Georg Medical University, Lucknow, over a duration of 1 year from January 2015 to January 2016. A total of 130 women who visited the department of obstetrics and gynecology for the treatment of infertility were included in the study. Ninety-eight women were enrolled for this study, and proper screening protocol was followed. 32 cases were excluded from the study due to screen failure. This study was approved by the institutional ethics committee. Written informed consent was obtained from all participants. Patients were recruited in this study after complete screening. Inclusion criteria for the study were Women with age ≤40 years, infertility duration of ≥1 year (primary or secondary), Single or bilateral Patent Fallopian tube More Details on hysterosalpingography (HSG) or sonosalpingography (SSG), with normal husband semen analysis (WHO guidelines 2010), couple with unexplained infertility or ovulatory disorder (polycystic ovarian syndrome, mild or minimal endometriosis and normal serum thyroid-stimulating hormone, serum prolactin, serum follicle-stimulating hormone (FSH), and luteinizing hormone levels. Women with age >40 years, bilateral tubal blockage, hydrosalpinx, abnormal endometrial cavity during HSG/SSG evaluation, and whose husband's semen reports were azoospermic were excluded from the study.
Standard hospital protocol was applied in each couple during ovulation induction and IUI procedure. Predetermined proforma was filled, with a history of couples which included demographic characteristics, menstrual and obstetrical history, any history of previous IUI cycle, drug intake, and any previous pelvic surgery. General, physical, and gynecological examination was done in every women and body mass index (BMI) was measured. On day 2 of cycle, baseline ultrasonography was performed to evaluate antral follicle count and any ovarian cyst.
Ovulation induction protocol
Ovulation induction was done by either clomiphene citrate, recombinant FSH, or the combination of both. Tablet clomiphene citrate 50–100 mg was given at bedtime from day 2 to day 6 for 5 days. Follicular monitoring was done again on day 7, and if sufficient follicle growth, then followed by repeated scan till follicle reached 18–20 mm and then human chorionic gonadotropin (HCG) stimulation. If follicular development was not sufficient, then injection recombinant FSH 75 IU was given on day 7. Repeated follicular monitoring was done, and if insufficient follicle development, then injection FSH was increased accordingly.
If the cycle was stimulated with injection recombinant FSH, then 75 IU recombinant FSH was given on day 2, 4, 6, 8, and 10; step-up protocol was followed. Follicular response was assessed by transvaginal ultrasound in stimulated cycle. Our aim was to develop monofollicular response. During follicular monitoring, follicular growth and endometrial thickness were measured. If >5 follicles of ≥18 mm diameter in size, then that cycle was canceled and couple was advised to avoid sex till next menses.
The patient was allotted randomly for single or double IUI on the day of HCG administration. When dominant follicle attained 18–20 mm of size recombinant or urinary preparation of injection hCG 5,000 IU was administered intramuscularly. Serum estradiol level was measured on the day of hCG administration. Written informed consent was obtained for IUI. Sperm preparation was done by swim-up technique. Single IUI was done after 36 h of injection of HCG or double IUI was done after 24–26 h and 36–40 h of injection HCG. IUI was done under all aseptic precautions. Luteal phase was supported by progesterone. Pregnancy test was done by serum β-hCG level estimation after 2 weeks of IUI or when woman missed her menses. After positive test, transvaginal ultrasound was done for the confirmation of pregnancy.
A biochemical pregnancy was defined as a small, transitory increase in β-hCG levels followed by a decrease level within a week. A clinical pregnancy was defined by visualization of a gestational sac during ultrasound examination at 6–7 weeks of pregnancy or by a serum β-hCG level of 1400 mIU in the absence of an ultrasound examination.
The statistical analysis was performed using SPSS 21 version (Chicago, IL, USA). The Chi-square test and t-test were used for comparison of data. Statistical significance was defined as P < 0.05. Data were expressed as mean ± standard deviation.
| Results|| |
In our study, women age ranges from 20 years to 40 years. The mean age of pregnant women was 25.40 ± 3.52 years and of those women who failed to conceive was 28.01 ± 3.21 years. Statistically significant difference was found with age. Here, the mean duration of infertility for pregnant women was 4.87 ± 3.27 years and of nonpregnant was 5.48 ± 3.12 years. The mean BMI of pregnant group was 23.00 ± 2.41 kg/m2 whereas in nonpregnant group BMI was 25.12 ± 3.32 kg/m2. This difference was statistically significant [Table 1].
No significant difference was found for either primary or secondary infertility among pregnant and nonpregnant groups. Among pregnant women, 86.7% women had bilateral patent fallopian tube while in nonpregnant group bilateral tubal patency was found in 88%. No statistically significant difference was observed between two groups [Table 2].
|Table 2: Patient parameter affecting controlled ovarian hyperstimulation/intrauterine inseminations|
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In both the groups, the most common cause of infertility was unexplained, 80.7% in nonpregnant group, and 93.3% in pregnant group. In women who failed to conceive another, responsible factors were anovulation in 9.6% and male factor in 9.6% women, whereas in pregnant group male factor present in 6.7% cases.
In 20% pregnant women, history of anti-tuberculosis therapy intake was found as compared to 10.8% in nonpregnant women group [Table 3].
Antral follicular count >5 present in 60% pregnant women than 63.9% nonpregnant women and the results were not statistically significant. No statistically significant difference was found for endometrial thickness between two groups on the day of ovulation. Serum estradiol level >600 present in 53.3% pregnant women as compared to 56.6% in nonpregnant women, and the difference was statistically not significant [Table 4].
Here, in the present study, no significant difference was found in sperm number and motility between pregnant and nonpregnant group (P value 0.375 and 0.979, respectively). There was no difference in the pregnancy rates using either double IUI or single IUI. Single dominant follicles were more in pregnant group (73.3%) as compared to nonpregnant group 40.2% and this difference was statistically significant [Table 5].
|Table 5: Factors affecting controlled ovarian hyperstimulation/intrauterine insemination cycles (controlled ovarian hyperstimulation/intrauterine inseminations)|
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| Discussion|| |
Burden of infertility is quite high in India, with an estimated 22–33 million couples in reproductive age suffering from lifetime infertility. The prevalence of infertility in India in 2015 was 10%–15%.,
The present study showed that infertile women who conceived after COH + IUI were of younger age as compared to women who failed to conceive after treatment, and this difference was significant; similarly, another study reported that pregnancy rate decreases with advancing age of women might be due to reduced quality of female oocytes.
In our study, though the mean duration of infertility in women who conceived was lesser as compared to the mean duration of infertility of women who failed to conceive, the difference was not statistically significant. Zainul et al. and Tay et al. did not find any significant association with duration of infertility., In contrast, Guzick et al. reported that pregnancy rates decrease with increasing duration of infertility.
In the present study, the mean BMI of women who conceived was significantly less as compared to those who failed to conceive, and this difference was statistically significant, but other authors did not found any association with BMI.
Although the higher number of conceptions was observed with primary infertility, no significant difference was observed with type of infertility either primary or secondary in relation to conception after treatment in both the groups; similar results were reported by another author.
In our study, statistically significant difference was not observed between two groups in terms of bilateral patency of fallopian tube, though the conception was higher with bilateral patent tube. No significant difference was observed in relation to etiological factors in both groups. Our results are comparable to the study done by another author who determined that etiology of infertility was not significantly different between pregnant and nonpregnant women.
No statistically significant difference was observed for endometrial thickness between two groups on the day of ovulation. Our results were comparable to the study done by Barker et al. and Rashidi et al. who have reported a nonsignificant difference in endometrial thickness between pregnant and nonpregnant groups., While Okohue et al. reported highest pregnancy rate with an endometrial thickness of 7–14 mm in IVF/ICSI cycles as compared to thickness <7mm or >14mm. In the present study, male factors, sperm counts, and motility did not affect pregnancy outcome and the difference between two the groups was not statistically significant. (P value 0.375 and 0.979, respectively). In our study 45.45% were normozoospermic in non-pregnant group while another study reported that all males partners in infertile couple groups were normozoospermic.
In our study, no difference was observed in the pregnancy rates using either double IUI or single IUI. One author has concluded that insemination timing and frequency have exert little effect in conception.
In this study, pregnancy rate after ovulation induction 15.30%, while other study reported 8.75%. No any case of hyperstimulation was documented during the study period.
The outcome of COH-IUI cycles may be affected by many parameters such as age, duration of infertility, dose of medication, and the number of mature follicles. In our study, woman's age, BMI, and single dominant follicles have significant impact on pregnancy outcomes, though other variables had no effect on pregnancy outcome. However, the limitation of our study is the small sample size and thus studies with large sample size are required to formulate a better predictive model for successful outcomes in IUI cycles.
| Conclusions|| |
Infertility remains a worldwide problem and has devastating psycho-social consequences on infertile couples. Management of infertility is still a difficult medical task because of the difficulty in the diagnosis and treatment of the reproductive disorders. Thus, it is necessary to find out definite prognostic factor helpful for determining the chances of success after ovulation induction and IUI. In our study, woman's age, BMI, and single dominant follicles have significant impact on pregnancy outcomes.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]