Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT02048891Other idRMB-0427-13

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 3 participants (actual)
Sponsor: Rambam Health Care Campus · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Israel
Start: Oct 2014
Primary completion: Jan 2015
Completion: Apr 2015
First posted: 29 Jan 2014 (estimated)
Last update posted: 8 Jun 2015 (estimated)
Conditions: Infertility

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201420152016

Ph 4
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
NCT02048891
Oct 2014 to Apr 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

GnRH agonist triggerDrug
hCG triggerDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Fetal Heart Activity 1 Month After Oocyte Retrieval
Time frame · 1 month after oocyte retrieval
Registry description
Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval

Secondary outcomes(1)

Patients Comfort During the Luteal Phase
Time frame · During 2 weeks from day of oocyte retrieval

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 1 month after oocyte retrieval

Fetal Heart Activity 1 Month After Oocyte Retrieval

Group	Value (participants with fetal heart activity)
hCG Trigger	0
GnRH Agonist Trigger	0

Secondary and other outcome results(1)

Secondary outcome· During 2 weeks from day of oocyte retrieval

Patients Comfort During the Luteal Phase

Group	Value

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
hCG TriggerOvulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily. hCG trigger	–	0 / 2	0 / 2
GnRH Agonist Triggerovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG. GnRH agonist trigger	–	0 / 1	0 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 35 Years up to 44 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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