Caesarean Section and Intracytoplasmic Sperm Injection (ICSI) Outcome
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Observational [Patient Registry]

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.
    

Intervention name(s): Frozen embryo transfer
Intervention type(s): Procedure
Intervention description(s): 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
Observational model: Cohort
Time perspective: Prospective
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