Female Infertility Clinical Trial
Official title:
Effect of Prior Caesarean Delivery on ICSI Outcome
NCT number | NCT05528835 |
Other study ID # | 0201611 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | March 15, 2023 |
Verified date | August 2022 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Although Caesarean section (CS) is often a necessary surgical intervention, it may also be associated with an increased risk of short- and long-term sequelae. It was thought that CS may increase the risk of female subfertility or even infertility. In assisted reproductive technology (ART) cycles, the process of implantation is believed to be the most important factor in determining pregnancy outcome. In view of conflicting results on the influence of a previous CS on outcomes of ART, this study will be conducted to investigate the impact of the mode of previous delivery on ICSI outcomes.
Status | Completed |
Enrollment | 140 |
Est. completion date | March 15, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility | Inclusion Criteria: - Patient age 20-35years. - BMI 18- 30. - Women with some indications for freeze all technique as patients with high risk for developing ovarian hyperstimulation syndrome (OHSS), patients with treatable tubal or uterine anomalies that were discovered during controlled ovarian hyperstimulation (COH) or in patients with elevated serum progesterone levels Exclusion Criteria: - Severe form of endometriosis. - Congenital uterine anomalies. - Scarred uterus due to previous myomectomy. - Women diagnosed with moderate to severe degrees of intrauterine adhesions. - Women with fibroid uteri. - Patients with bad quality embryos. - Untreated hydrosalpinges. - All fresh transfer cycles will be excluded. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671. — View Citation
Brosens JJ, Gellersen B. Something new about early pregnancy: decidual biosensoring and natural embryo selection. Ultrasound Obstet Gynecol. 2010 Jul;36(1):1-5. doi: 10.1002/uog.7714. No abstract available. — View Citation
Ciray HN, Aksoy T, Yaramanci K, Karayaka I, Bahceci M. In vitro culture under physiologic oxygen concentration improves blastocyst yield and quality: a prospective randomized survey on sibling oocytes. Fertil Steril. 2009 Apr;91(4 Suppl):1459-61. doi: 10.1016/j.fertnstert.2008.07.1707. Epub 2008 Aug 22. — View Citation
D'Antonio F, Timor-Tritsch IE, Palacios-Jaraquemada J, Monteagudo A, Buca D, Forlani F, Minneci G, Foti F, Manzoli L, Liberati M, Acharya G, Cali G. First-trimester detection of abnormally invasive placenta in high-risk women: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Feb;51(2):176-183. doi: 10.1002/uog.18840. — View Citation
Duperron L. Should patients be entitled to cesarean section on demand?: Yes. Can Fam Physician. 2011 Nov;57(11):1246, 1248, 1250 passim. No abstract available. — View Citation
Mylonas I, Friese K. Indications for and Risks of Elective Cesarean Section. Dtsch Arztebl Int. 2015 Jul 20;112(29-30):489-95. doi: 10.3238/arztebl.2015.0489. — View Citation
O'Neill SM, Kearney PM, Kenny LC, Henriksen TB, Lutomski JE, Greene RA, Khashan AS. Caesarean delivery and subsequent pregnancy interval: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2013 Aug 27;13:165. doi: 10.1186/1471-2393-13-165. — View Citation
Patounakis G, Ozcan MC, Chason RJ, Norian JM, Payson M, DeCherney AH, Yauger BJ. Impact of a prior cesarean delivery on embryo transfer: a prospective study. Fertil Steril. 2016 Aug;106(2):311-6. doi: 10.1016/j.fertnstert.2016.03.045. Epub 2016 Apr 14. — View Citation
Tollanes MC, Melve KK, Irgens LM, Skjaerven R. Reduced fertility after cesarean delivery: a maternal choice. Obstet Gynecol. 2007 Dec;110(6):1256-63. doi: 10.1097/01.AOG.0000292089.18717.9f. — View Citation
Vissers J, Hehenkamp W, Lambalk CB, Huirne JA. Post-Caesarean section niche-related impaired fertility: hypothetical mechanisms. Hum Reprod. 2020 Jul 1;35(7):1484-1494. doi: 10.1093/humrep/deaa094. — View Citation
Wang L, Yao W, Tang X, Yao H, Wei S, Huang J, Mol BWJ, Jin L, Yue J, Wang R. Fertility outcomes of IVF/ICSI after Caesarean section: a cohort study. Reprod Biomed Online. 2020 May;40(5):719-728. doi: 10.1016/j.rbmo.2019.12.004. Epub 2019 Dec 16. — View Citation
Zhang N, Chen H, Xu Z, Wang B, Sun H, Hu Y. Pregnancy, Delivery, and Neonatal Outcomes of In Vitro Fertilization-Embryo Transfer in Patient with Previous Cesarean Scar. Med Sci Monit. 2016 Sep 16;22:3288-95. doi: 10.12659/msm.900581. — View Citation
Zhao J, Hao J, Xu B, Wang Y, Li Y. Impact of previous Caesarean section on reproductive outcomes after assisted reproductive technology: systematic review and meta-analyses. Reprod Biomed Online. 2021 Aug;43(2):197-204. doi: 10.1016/j.rbmo.2021.04.007. Epub 2021 Apr 22. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implantation rate | The ratio between the number of gestational sacs visualized by transvaginal ultrasound and the number of transferred embryos. | 4 weeks after embryo transfer | |
Primary | Clinical pregnancy | Determined by the visualization of a viable embryo within the uterine cavity by ultrasound 4 weeks after embryo transfer. Clinical pregnancy rate will be calculated as the number of clinical pregnancies divided by the number of embryo transfer procedures. | 4 weeks after embryo transfer | |
Secondary | Biochemical pregnancy | Positive pregnancy test 11 days after embryos transfer followed by abnormally rising or subsequently declining human chorionic gonadotropin (hCG) levels along with the absence of a visualized gestational sac on a transvaginal ultrasound. The biochemical pregnancy rate is defined as the total number of biochemical pregnancies divided by the total number of positive pregnancy tests following an embryo transfer. | 11 days after embryo transfer | |
Secondary | Ongoing pregnancy | Ratio between ongoing pregnancies proceeding beyond the 20th gestational weeks to the number of embryo transfer procedures | 18 week after embryo transfer | |
Secondary | Miscarriage rate | Calculated as the total number of pregnancies that failed to progress after visualization of an intrauterine gestational sac divided by the total number of clinically recognized intrauterine pregnancies. | 18 week after embryo transfer |
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