Caesarean Section and Intracytoplasmic Sperm Injection (ICSI) Outcome

NCT05528835 | Completed

• 1 other identifier: 0201611
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Biochemical pregnancy

  11 days after embryo transfer

• Ongoing pregnancy

  18 week after embryo transfer

• Miscarriage rate

  18 week after embryo transfer

Study Arms (2)

Group A

Women with history of previous one Caesarean section

Procedure: Frozen embryo transfer

Group B

Women with history of previous normal vaginal delivery.

Procedure: Frozen embryo transfer

Interventions

Frozen embryo transfer PROCEDURE

All women in both groups will receive oral estradiol valerate 8 mg/ day from the second day of the menstrual cycle. Endometrial thickness will be assessed by vaginal ultrasonography at the tenth day of treatment. When endometrial thickness reached ≥ 7 mm all subjects, in addition to estrogen, they will receive progesterone vaginal suppositories 400 mg twice daily and 100 mg of progesterone intramuscularly daily. Frozen thawed embryo transfer will be at day 6 of progesterone. Estrogen and progesterone will be continued until 9-10 weeks of gestation

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women complaining of secondary infertility, whether delivered vaginally or by one previous C.S, who will undergo ICSI in the IVF private centers

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, 21131, Egypt

Location

Related Publications (13)

• 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.

  PMID: 34130991 BACKGROUND

• 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.

  PMID: 26249251 BACKGROUND

• 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.

  PMID: 22084452 BACKGROUND

• 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.

  PMID: 28833750 BACKGROUND

• 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.

  PMID: 23981569 BACKGROUND

• 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.

  PMID: 18055718 BACKGROUND

• 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.

  PMID: 32613231 BACKGROUND

• 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.

  PMID: 20582930 BACKGROUND

• 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.

  PMID: 34253450 BACKGROUND

• 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.

  PMID: 32336649 BACKGROUND

• 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.

  PMID: 27087400 BACKGROUND

• 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.

  PMID: 27636504 BACKGROUND

• 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.

  PMID: 18722608 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Mohammed AbdElmoety El Samra, phD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Mohammed Salah Abd Rabbo, PhD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 22 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: March 15, 2023
• Last Updated: August 28, 2023

Record last verified: 2022-08

Locations

EG (1)