Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders

NCT04224818 | Completed Phase 3

• 1 other identifier: BIO-2018-0020
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Poor Ovarian Reserve

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Fertilization rate

  48 hrs

• Clinical pregnancy rate

  7 weeks

• Implantation rate

  7 weeks

• Miscarriage rate

  12 weeks

Study Arms (2)

Dual trigger

EXPERIMENTAL

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

hCG (standard)

ACTIVE COMPARATOR

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)

Interventions

Dual trigger DRUG

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

Also known as: Dual ovulation trigger (Choriomon and Triptorelin)

Dual trigger

hCG (standard) DRUG

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

Also known as: human Chorionic Gonadotropin

hCG (standard)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Interventions

Triptorelin Pamoate; Chorionic Gonadotropin

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropins; Placental Hormones; Pregnancy Proteins

Study Officials

• Ghina S Ghazeeri, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: January 13, 2020
• Study Start: July 11, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 30, 2019
• Last Updated: July 23, 2021

Record last verified: 2021-01

Locations

LE (1)