Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders

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

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.

Study Overview

• Status: Completed
• Conditions: Poor Ovarian Reserve
• Intervention / Treatment: Drug: Dual trigger; Drug: hCG (standard)

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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Dual trigger; Dual trigger: human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) + Gonadotropin-Releasing Hormone agonist (Triptorelin 0.3 mg subcutaneous once); Other Names: Dual ovulation trigger (Choriomon and Triptorelin)
Active Comparator: 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.	Drug: hCG (standard); human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once); Other Names: human Chorionic Gonadotropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of mature oocytes (oocyte maturation rate)	the ratio of MII oocytes to the number of collected oocytes	38 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization rate	the ratio of normal fertilized oocytes (2PN) to the number of oocytes used for fertilization	48 hrs
Clinical pregnancy rate	the presence of fetal cardiac activity confirmed by transvaginal ultrasound 7 weeks after embryo transfer	7 weeks
Implantation rate	the number of gestational sacs visualized on ultrasound examination divided by the number of embryos transferred	7 weeks
Miscarriage rate	the spontaneous loss of a clinical pregnancy occurring before 12 completed weeks of gestational age	12 weeks

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Ghina S Ghazeeri, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2018
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate; Chorionic Gonadotropin
• Other Study ID Numbers: BIO-2018-0020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No