Caesarean Section and Intracytoplasmic Sperm Injection (ICSI) Outcome

Completed

• Conditions: Female Infertility
• Interventions: Procedure: Frozen embryo transfer

• Registration Number: NCT05528835
• Lead Sponsor: Alexandria University

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.

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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-08
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-06
• Primary Completion: 2023-01-01
• Study Completion: 2023-03-15
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Frozen embryo transfer	Women with history of previous one Caesarean section
Group B	Frozen embryo transfer	Women with history of previous normal vaginal delivery.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy	4 weeks after embryo transfer	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.
Implantation rate	4 weeks after embryo transfer	The ratio between the number of gestational sacs visualized by transvaginal ultrasound and the number of transferred embryos.

Secondary Outcome Measures

Name	Time	Method
Miscarriage rate	18 week after embryo transfer	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.
Ongoing pregnancy	18 week after embryo transfer	Ratio between ongoing pregnancies proceeding beyond the 20th gestational weeks to the number of embryo transfer procedures
Biochemical pregnancy	11 days after embryo transfer	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.

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt