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

NCT ID: NCT02048891

Last Updated: 2015-06-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-04-30

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hCG trigger

Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.

Group Type ACTIVE_COMPARATOR

hCG trigger

Intervention Type DRUG

GnRH agonist trigger

ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.

Group Type EXPERIMENTAL

GnRH agonist trigger

Intervention Type DRUG

Interventions

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GnRH agonist trigger

Intervention Type DRUG

hCG trigger

Intervention Type DRUG

Other Intervention Names

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Oovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG. Ovulation trigger with Ovitrelle 250 microgram. Luteal support with daily progesterone gel = Crinone 8%

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Shahar Kol MD

Director, IVF Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IVF Unit, Rambam medical Center

Haifa, Israel, Israel

Site Status

Countries

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Israel

Other Identifiers

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RMB-0427-13

Identifier Type: -

Identifier Source: org_study_id

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