Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders

Phase 3

Completed

• Conditions: Poor Ovarian Reserve
• Interventions: Drug: Dual trigger; Drug: hCG (standard)

• Registration Number: NCT04224818
• Lead Sponsor: American University of Beirut Medical Center

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

Study Timeline

• Study Start: 2018-07-11
• Primary Completion: 2019-08-20
• Study Completion: 2019-08-30
• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Status Verified: 2021-01
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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)

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Exclusion Criteria

• Abnormal uterine cavity (Hysteroscopy or HSG)
• Evidence of untreated endocrine disorders (abnormal TSH, prolactin, testosterone and androstenedione concentrations)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual trigger	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.
hCG (standard)	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.

Primary Outcome Measures

Name	Time	Method
Number of mature oocytes (oocyte maturation rate)	38 hrs	the ratio of MII oocytes to the number of collected oocytes
Number of oocytes retrieved (oocyte collection rate)	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 Outcome Measures

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

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon