Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: hCG trigger; Drug: GnRH agonist trigger

• Registration Number: NCT02048891
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given.

The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-29
• Study Start: 2014-10
• Primary Completion: 2015-01
• Study Completion: 2015-04
• Results First Submitted: 2015-04-29
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-20
• Last Update Submitted: 2015-05-20
• Results First Posted: 2015-06-08
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• IVF patients with at least 4 consecutive failures.
• On trigger day, no more than 10 follicles of 12 mm and up

Exclusion Criteria

• History of moderate or severe OHSS.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hCG trigger	hCG trigger	Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
GnRH agonist trigger	GnRH agonist trigger	ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.

Primary Outcome Measures

Name	Time	Method
Fetal Heart Activity 1 Month After Oocyte Retrieval	1 month after oocyte retrieval	Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval

Secondary Outcome Measures

Name	Time	Method
Patients Comfort During the Luteal Phase	During 2 weeks from day of oocyte retrieval

Trial Locations

Locations (1)

IVF Unit, Rambam medical Center; 🇮🇱 Haifa, Israel