The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies

NCT03169166 | Completed Phase 4

• 1 other identifier: AmericanUBMCGNRH
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective comparative randomized controlled trial investigating the effect of two GnRH agonist trigger protocols on the ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology.

Conditions

Sterility; Infertility

Keywords

GnRH agonist; In Vitro fertilization; Assisted Reproductive Technology; Follicule Maturation; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology cycles

  20 weeks from Last Menstrual Period (LMP)

Secondary Outcomes (1)

• Oocyte collection rate

  On the day of ovum pick-up

Other Outcomes (5)

• Fertilization rate

  16-18 hours post insemination

• Total pregnancy rate

  10-12 days from embryo transfer

• Clinical pregnancy rate

  7 weeks from LMP

Study Arms (2)

Repeated 3-dose GnRHa " Triptorelin"

EXPERIMENTAL

Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart (0.3/0.2/0.2mg) when at least three follicles 18 mm in diameter have been observed by ultrasound examination.

Drug: Triptorelin

Conventional 1-dose GnRHa " Triptorelin"

NO INTERVENTION

Triptorelin pre-filled syringes will be administered subcutaneously in a single dose (0.3 mg) when at least three follicles 18 mm in diameter have been observed by ultrasound examination.

Interventions

Triptorelin DRUG

Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart

Also known as: Gonapeptyl

Repeated 3-dose GnRHa " Triptorelin"

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Normal uterine cavity (as assessed by hysteroscopy or HSG).
• Normal hormonal investigation: TSH, PRL.
• More than 15 follicles (≥12 mm in diameter) on ultrasound, and/or estradiol level of \> 3500 pg/ml on the day of trigger.

You may not qualify if:

• History of three or more miscarriages.
• History of three or more previous IVF failures.
• Abnormal uterine cavity (Hysteroscopy or HSG).

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

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

Study Officials

• Johnny Awwad, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 30, 2017
• Study Start: March 1, 2017
• Primary Completion: July 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

LE (1)