NCT05528835

Caesarean Section and Intracytoplasmic Sperm Injection (ICSI) Outcome

Effect of Prior Caesarean Delivery on ICSI Outcome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The use of CS has steadily increased worldwide and will continue increasing over the current decade where both unmet need and overuse are expected to coexist. The medical field now acknowledges a patient's right to actively participate in her choice of medical treatments, including the method of delivery what is known as CS on demand, a primary CS performed on the mother's request without any recognized medical or obstetric Indications that may also increase the rate of C.S. Although CS is often a necessary surgical intervention, it may also be associated with an increased risk of short- and long-term sequelae eg. infection, haemorrhage and increased risk of several obstetric complications in subsequent pregnancies, including mal-placentation, Caesarean scar pregnancies, morbidly adherent placentae and uterine rupture. It was thought that CS may increase the risk of female subfertility or even infertility. The possible reasons for this impact on fertility may be related to infections, adhesions formation, placental bed disruption or other non-medical factors (age, culture, education). Different mechanisms were hypothesized to explain the detrimental uterine environment associated with the presence of CS niche, that may lead to subfertility including accumulation of intrauterine fluid, altered immunobiology, increased inflammation, distorted contractility of the uterus caused by fibrosis or interruption of the myometrial layer at the site of the niche. In ART cycles, the process of implantation is believed to be the most important factor in determining pregnancy outcome, because the embryos are directly transferred into the uterine cavity and so the tubal factor can be excluded. To date, knowledge on the influence of a previous CS on outcomes of ART is limited with different conclusions in terms of live birth, miscarriage and implantation rates. In view of these conflicting results, more adequately powered studies are warranted. Therefore, this study will be conducted to investigate the impact of the mode of previous delivery on ICSI outcomes.

Conditions

• Female Infertility

Interventions

Type	Name	Description
PROCEDURE	Frozen embryo transfer	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

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-01-01
• Completion: 2023-03-15
• First posted: 2022-09-06
• Last updated: 2023-08-28

Locations

1 site across 1 country: Egypt