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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000242628
Enrollment
120
Registered
2014-03-06
Start date
2014-03-20
Completion date
2014-10-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 (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

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.

Sponsors

Recai Pabuccu, Proff., M.D.
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

-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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026