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Completed

NCT Number: NCT03039049

GNRH Agonist Trigger and Modified Luteal Phase Adding a Bolus of GnRHa at the Time of Implantation: a RCT

Purpose:The aim of this project is to prospectively determine whether a single dose of GnRH-agonist administered at the time of implantation increases or not the reproductive outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic gonadotropin (hCG 1500 IU) the day of oocyte retrieval.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ibnrochd Clinic, Constantine, Algeria

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About this study

It has been reported in previous publications that the ovarian hyperstimulation syndrome (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate has improved after modified luteal support especially when a small bolus of hCG is used on the day of oocyte retrieval. (OMEGA/HCG 1500 IU).

However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus, further modifications in the luteal phase supplementation are required in order to optimise the reproductive outcome after GnRH-agonist triggering.

Recently, many papers showed, that independently of the GnRH analogue used to prevent the premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted because of controversial results in terms of efficacy and safety particularly on the conceptus.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Female age < 40 years No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities• Baseline FSH and LH < 12 IU/l.Patients with at least one embryo at transfer time

Exclusion criteria

  • Very high risk of OHSS (> 30 follicles > 12 mm the day of ovulation triggering). • Reduced ovarian reserve
  • Fertilization failure
  • Severe endocrinopathy
  • Azoospermia

Treatment and study plan

Triptorelin 0.1 mg

Drug

a single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval.

Other names: Decapeptyl 0.1 mg

Primary outcomes

  1. implantation rate

    Time frame: Time Frame: 5 weeks after IVF/ICSI

    number of gestational sacs per number of embryos transferred

Secondary outcomes

  1. positive pregnancy test

    Time frame: Time Frame: 2 weeks after IVF/ICSI

    confirmed by beta-hCG 14 days post embryo transfer

  2. Ongoing pregnancy

    Time frame: Time Frame: 12 weeks after IVF/ICSI

    presence of foetal heart beat at 12 weeks of gestation

  3. Delivery rate

    Time frame: Time Frame: 26 weeks after IVF/ICSI

    birth of baby beyond 26 weeks of gestation

  4. Early pregnancy loss

    Time frame: Time Frame: miscarriage before 5 weeks of gestation

    loss of embryo before 5 weeks of gestation, chemical pregnancy and extra-uterine pregnancy

Other outcomes

  1. ovarian hyperstimulation syndrome OHSS

    Time frame: Time Frame: from date of triggering until 2 weeks after pregnancy test]

    early and late onset Ovarian hyper stimulation syndrome

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Ibn Rochd

Other

Registry information

Official study title

GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Mid-luteal Bolus of GnRHa: a Randomised Controlled Trial.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2017
Registry last updated
Jul 7, 2017

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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