CompletedPhase 4ACTRN12614000242628

Cycle outcome assessment of patients with Anti-Mullerian-Hormone (AMH) levels above 4ng/mL that are undergoing in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) with short antagonist ovarian stimulation

Cycle Outcome Assessment of Patients with Anti-Mullerian-Hormone (AMH) levels above 4ng/mL that are Undergoing in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) with Short Antagonist Ovarian Stimulation


Sponsor

Recai Pabuccu, Proff., M.D.

Enrollment

150 participants

Start Date

Mar 20, 2014

Study Type

Interventional

Conditions

Summary

Infertile patients undergoing IVF/ICSI procedure with AMH levels greater than 4ng/mL represents clear risk for excessive ovarian response and ovarian hyper stimulation syndrome development under literature findings. Novel ovarian stimulation protocols and gonadotropin dose modifications have been proposed to prevent OHSS and achieve successful pregnancies so far. In the current study, fix 150 IU of gonadotropin stimulation along with fix day 6 antagonist protocol will be investigated in terms of excessive ovarian response and cycle outcomes in high responder infertile patients with AMH levels above 4ng/mL. Comparison of cycle outcomes will be performed between different sub-groups of AMH, body mass index and insulin resistancy situation. Also, most determining factors that may influence pregnancy and OHSS rates will be investigated.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria1

  • Patients with primary or secondary infertility who require IVF/ICSI procedure with Anti Mullerian Hormone levels above 4 ng/mL

Exclusion Criteria6

  • patients with severe male factor infertility
  • patients who will receive GnRH agonist for ovulation triggering due to excessive ovarian response
  • inadequate or poor ovarian response to gonadotropins
  • patients with AMH levels lower than 4 ng/mL
  • patients with hypogonadotropic hypogonadism (WHO group 1 infertility)
  • Patients with medical disorder that provides contraindication to assisted reproduction techniques.

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Interventions

A cohort of infertile patients with AMH levels above 4ng/mL that require IVF/ICSI treatment will be included in this trial. After scheduling the treatment procedure, controlled ovarian stimulation (CO

A cohort of infertile patients with AMH levels above 4ng/mL that require IVF/ICSI treatment will be included in this trial. After scheduling the treatment procedure, controlled ovarian stimulation (COH) using 150IU recombinant gonadotropin will be initiated. Beginning from the 6th day of the cycle, all patients will receive Gonadotropin releasing hormone (GnRH) antagonist shot 0,25mg daily untill final oocyte maturation (when leading follicle reaches diameter of 18 mm). Following COH, ovulation triggering (final oocyte maturation) will be planned and ultrasound guided oocyte retrieval process will be performed 34-36 hours after triggering ovulation for each patient. After obtaining enough number of mature oocytes per patient, intra cytoplasmic sperm injection will be performed on the retrieval day. Depending on the number and quality of embryos, embryo transfer procedure will be performed under ultrasound guidance for each patient. Finally, all cycle outcomes including hormone profiles, total duration of cycles, total gonadotropin consumption, peak estradiol levels, number of retrieved and good quality embryos, pregnancy rates and ovarian hyper stimulation syndrome rates will be determined. Estimated total duration of observation is 1 to 3 months.


Locations(1)

Turkey

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ACTRN12614000242628