Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders

NCT ID: NCT04224818

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-11
• Study Completion Date: 2019-08-30

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

Conditions

Poor Ovarian Reserve

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dual trigger

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

hCG (standard)

Intervention Type: DRUG

human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once)

Interventions

Dual trigger

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

Intervention Type: DRUG

hCG (standard)

human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once)

Intervention Type: DRUG

Other Intervention Names

Dual ovulation trigger (Choriomon and Triptorelin); human Chorionic Gonadotropin

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ghina S Ghazeeri, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

American University of Beirut Medical Center

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

BIO-2018-0020

Identifier Type: -

Identifier Source: org_study_id