Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders

American University of Beirut Medical Center

Status and phase: Completed; Phase 3

Conditions: Poor Ovarian Reserve

Treatments: Drug: hCG (standard); Drug: Dual trigger

Study type: Interventional

Funder types: Other

Identifiers

NCT04224818

BIO-2018-0020

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Dual trigger

Experimental group

Description:

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.

Treatment:

Drug: Dual trigger

hCG (standard)

Active Comparator group

Description:

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.

Treatment:

Drug: hCG (standard)