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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039049
• Other study ID #: 02053779
• Status: Completed
• Phase: Phase 3
• First received: January 30, 2017
• Last updated: July 5, 2017
• Start date: March 2014
• Est. completion date: March 2017

Study information

• Verified date: July 2017
• Source: Centre Hospitalier Universitaire Ibn Rochd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
Algeria	Ibnrochd Clinic	Constantine
Algeria	Ibnrochd IVF center	Constantine

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Ibn Rochd

Country where clinical trial is conducted

Algeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ovarian hyperstimulation syndrome OHSS	early and late onset Ovarian hyper stimulation syndrome	Time Frame: from date of triggering until 2 weeks after pregnancy test]
Primary	implantation rate	number of gestational sacs per number of embryos transferred	Time Frame: 5 weeks after IVF/ICSI
Secondary	positive pregnancy test	confirmed by beta-hCG 14 days post embryo transfer	Time Frame: 2 weeks after IVF/ICSI
Secondary	Ongoing pregnancy	presence of foetal heart beat at 12 weeks of gestation	Time Frame: 12 weeks after IVF/ICSI
Secondary	Delivery rate	birth of baby beyond 26 weeks of gestation	Time Frame: 26 weeks after IVF/ICSI
Secondary	Early pregnancy loss	loss of embryo before 5 weeks of gestation, chemical pregnancy and extra-uterine pregnancy	Time Frame: miscarriage before 5 weeks of gestation