Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders

Poor Ovarian Reserve Clinical Trial

Official title:

Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224818
• Other study ID #: BIO-2018-0020
• Status: Completed
• Phase: Phase 3
• Start date: July 11, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: January 2021
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 30, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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)

Related Conditions & MeSH terms

• Poor Ovarian Reserve

Intervention

Drug:
• Dual trigger
Dual trigger: human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) + Gonadotropin-Releasing Hormone agonist (Triptorelin 0.3 mg subcutaneous once)
• hCG (standard)
human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once)

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved (oocyte collection rate)	the total number of oocytes retrieved divided by the number of follicles aspirated (diameter =10 mm) on the day of oocyte retrieval	38 hrs
Primary	Number of mature oocytes (oocyte maturation rate)	the ratio of MII oocytes to the number of collected oocytes	38 hrs
Secondary	Fertilization rate	the ratio of normal fertilized oocytes (2PN) to the number of oocytes used for fertilization	48 hrs
Secondary	Clinical pregnancy rate	the presence of fetal cardiac activity confirmed by transvaginal ultrasound 7 weeks after embryo transfer	7 weeks
Secondary	Implantation rate	the number of gestational sacs visualized on ultrasound examination divided by the number of embryos transferred	7 weeks
Secondary	Miscarriage rate	the spontaneous loss of a clinical pregnancy occurring before 12 completed weeks of gestational age	12 weeks