The Effect of Dual Trigger for Final Oocyte Maturation on IVF/ICSI Outcomes in Patients With Suboptimal Ovarian Response

NCT04549649 | Completed DMC

• 1 other identifier: Research ID (96000024)
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, in patients with a suboptimal ovarian response, a study of the role of adding a single dose of GnRH agonist to a standard dose of hCG to initiate final oocyte maturation has also been studied. Griffin et al. (2014) reported that in patients who had more than 25% immature oocytes in their previous IVF cycle, the use of dual stimulation could increase the number of mature oocytes. Since studies in this field are limited, the researchers decided to design a clinical trial to investigate the effect of adding a GnRH agonist to a standard dose of hCG to initiate final oocyte maturation in patients with a sub-optimal ovarian response.

Conditions

Ovarian Stimulation; Reproductive Techniques, Assisted

Keywords

Poor ovarian response; Dual trigger; GnRH antagonist protocol

Outcome Measures

Primary Outcomes (3)

• Total number of retrieved oocytes

  In one hour after ovum pick-up, outcome measurement will be possible.

  Day of oocyte pick-up (32-34 hours after hCG administration)

• Total number of mature or metaphase II (MII) oocytes

  In one hour after ovum pick-up, counting the total number of MII oocytes will be possible.

  Day of oocyte pick-up ( 32-34 hours after hCG administration )

• Oocyte recovery ratio

  Ratio of the total number of follicles above 18 mm to the total number of retrieved oocytes

  32-34 hours after oocyte triggering

Secondary Outcomes (2)

• Fertilization rate

  Day 1 post oocyte retrieval

• Quality of obtained embryos: grade

  3 days after in vitro fertilization/ intracytoplasmic sperm injection (IVF/ICSI) procedure

Study Arms (2)

Group A (Experimental oocyte triggering approach)

EXPERIMENTAL

0.2 mg Triptorelin (Decapeptyl; Ferring GmbH) associated with two ampoules of Ovitrelle (Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) will be administered subcutaneously simultaneously for final oocyte triggering.

Other: Dual triggering

Group B (Routine oocyte triggering approach)

NO INTERVENTION

Two ampoules of Ovitrelle® (Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) will be injected subcutaneously for final oocyte triggering.

Interventions

Dual triggering OTHER

Adding GnRH agonist (0.2 mg Triptorelin (Decapeptyl; Ferring GmbH) to routine oocyte triggering (two ampoules of Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) is defined as dual triggering.

Group A (Experimental oocyte triggering approach)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with poor ovarian response (POR) diagnosis according to the POSEIDON stratification system (as POSEIDON group 1) with following criteria :
• Women' age under 35 years;
• Previous unexpected poor or suboptimal ovarian response after using conventional protocols (subgroup 1a: \< 4 oocytes ) and (subgroup 1b: 4-9 oocytes retrieved)
• Adequate ovarian reserve (antral follicle count ≥5 on menstrual cycle day 2-3; and basal serum AMH ≥ 1.2 ng/ml)

You may not qualify if:

• Ovarian failure including basal FSH above 20 IU/l or no antral follicle by ultrasound examination;
• Endometriosis grade 3 or higher;
• Severe male infertility (surgical sperm extraction: TESE, PESA)
• Body mass index \>30 kg/ m2
• History of uterine surgery as well as sub-mucosal and intramural fibroids greater than 5 cm or uterine polyps
• Treatment cycles with pre-implantation genetic diagnosis, blastocyst and donation embryo transfer indications
• Cigarette and drug addiction

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, 16635148, Iran

Location

Related Publications (1)

• Hafezi M, Arabipoor A, Zareei M, Vesali S, Mostafaei P, Zameni N. The Effect of Dual Trigger on In Vitro Fertilization/Intracytoplasmic Sperm Injection Outcomes in Patients with Suboptimal Ovarian Response (POSEIDON Classification Group I): A Randomized Clinical Trial. Int J Fertil Steril. 2025 May 14;19(3):251-258. doi: 10.22074/ijfs.2025.2027114.1669.

  PMID: 40590283 DERIVED

MeSH Terms

Conditions

Helping Behavior

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Maryam Hafezi, M.D.

  Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: September 16, 2020
• Study Start: November 1, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After finishing the study and publishing the results.
• Access Criteria: Contact the principal investigator by Email.

Locations

IR (1)