Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders: A Prospective Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Dual trigger
- Conditions
- Poor Ovarian Reserve
- Sponsor
- American University of Beirut Medical Center
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Number of mature oocytes (oocyte maturation rate)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a randomized controlled clinical trial to investigate the effect of dual trigger (hCG and GnRH agonist) on the final oocyte maturation compared to the standard hCG trigger in patients with poor ovarian reserve seeking IVF/ICSI treatment.
Detailed Description
Women with POR (Bologna criteria) manifest a very low follicular response to controlled ovarian stimulation irrespective of the stimulation protocol utilized. Dual triggering of oocyte maturation was shown to improve follicle collection yield and oocyte maturation in women with predicted normal ovarian response. These benefits have been attributed to the GnRHa-induced FSH surge believed to promote oocyte nuclear maturation and cumulus expansion. The aim of the study is to show whether the co-administration of a GnRH agonist and hCG for final oocyte maturation improve oocyte collection and maturation rate
Investigators
Eligibility Criteria
Inclusion Criteria
- •Normal uterine cavity (as assessed by hysteroscopy or HSG).
- •Normal hormonal investigation: TSH, PRL.
- •Low ovarian reserve patients (AMH\<1.5ng/ml, AFC of 7 or less, 5 oocytes or less retrieved in a previous cycle)
Exclusion Criteria
- •Abnormal uterine cavity (Hysteroscopy or HSG)
- •Evidence of untreated endocrine disorders (abnormal TSH, prolactin, testosterone and androstenedione concentrations)
Arms & Interventions
Dual trigger
Dual trigger: (0.3 mg GnRHa = triptorelin) with + HCG (Choriomon)10 000 IU . will be administered subcutaneously in a single dose 0.3 mg with 10 000 HCG when at least 2 follicles 18 mm in diameter have been observed by ultrasound examination.
Intervention: Dual trigger
hCG (standard)
HCG (Choriomon) of 10 000 IU will be administered subcutaneously in a single dose when at least 2 follicles 18 mm in diameter have been observed by ultrasound examination.
Intervention: hCG (standard)
Outcomes
Primary Outcomes
Number of mature oocytes (oocyte maturation rate)
Time Frame: 38 hrs
the ratio of MII oocytes to the number of collected oocytes
Number of oocytes retrieved (oocyte collection rate)
Time Frame: 38 hrs
the total number of oocytes retrieved divided by the number of follicles aspirated (diameter ≥10 mm) on the day of oocyte retrieval
Secondary Outcomes
- Clinical pregnancy rate(7 weeks)
- Implantation rate(7 weeks)
- Miscarriage rate(12 weeks)
- Fertilization rate(48 hrs)