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Completed

NCT Number: NCT03169166

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

American University of Beirut Medical Center

Beirut, Lebanon

About this study

Follicle maturation triggering is the final differentiation process of an immature egg before fertilization, either in normal or stimulated ovarian cycles in assisted reproductive techniques. This step has traditionally been accomplished by the administration of human chorionic gonadotropin (hCG) trigger which mimics LH activity. However, hCG is a primary cause of severe ovarian hyperstimulation syndrome (OHSS) in women and appears to initiate the complex cascade that leads to the development of serious medical complications. Numerous strategies have been suggested to prevent OHSS; one of these is the administration of a gonadotropin releasing hormone (GnRH) agonist trigger instead of hCG. Despite a high safety profile, the GnRH agonist trigger of follicle maturation was found to be associated with a decreased probability of clinical and ongoing pregnancy rates and very high miscarriage rates. A profoundly deficient luteal phase is believed to be the cause of compromised reproductive outcome. Our personal clinical practice at the AUBMC Fertility Center seems to indicate that a novel GnRH agonist administration protocol is associated with a comparable reproductive performance to standard hCG trigger. In this study, we aim to validate the above clinical impression and assess associated parameters of success. Therefore, a prospective comparative randomized controlled trial will be performed in order to investigate the effect of three repeated doses of GnRH agonist trigger "Triptorelin" accompanied by intensive Luteal Support on the ongoing pregnancy outcome in women who are hyper-responders to ovarian stimulation when undergoing assisted reproductive technology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Triptorelin

Drug

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

Other names: Gonapeptyl

Primary outcomes

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

    Time frame: 20 weeks from Last Menstrual Period (LMP)

Secondary outcomes

  1. Oocyte collection rate

    Time frame: On the day of ovum pick-up

    oocyte maturation rate ovarian volume on the day of hCG titer

Other outcomes

  1. Fertilization rate

    Time frame: 16-18 hours post insemination

  2. Total pregnancy rate

    Time frame: 10-12 days from embryo transfer

  3. Clinical pregnancy rate

    Time frame: 7 weeks from LMP

  4. Implantation rate

    Time frame: 7 weeks from LMP

  5. Miscarriage rate

    Time frame: From a positive pregnancy test till 20 weeks gestation

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies: A Prospective Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 30, 2017
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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