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

NCT02048891 | Completed Phase 4 Results

• 1 other identifier: RMB-0427-13
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Fetal Heart Activity 1 Month After Oocyte Retrieval

  Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval

  1 month after oocyte retrieval

Secondary Outcomes (1)

• Patients Comfort During the Luteal Phase

  During 2 weeks from day of oocyte retrieval

Study Arms (2)

hCG trigger

ACTIVE COMPARATOR

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

Drug: hCG trigger

GnRH agonist trigger

EXPERIMENTAL

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

Drug: GnRH agonist trigger

Interventions

GnRH agonist trigger DRUG

Also known as: Oovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.

GnRH agonist trigger

hCG trigger DRUG

Also known as: Ovulation trigger with Ovitrelle 250 microgram., Luteal support with daily progesterone gel = Crinone 8%

hCG trigger

Eligibility Criteria

• Age: 35 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of moderate or severe OHSS.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

IVF Unit, Rambam medical Center

Haifa, Israel, 31096, Israel

Location

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Shahar Kol Director IVF Unit
• Organization: Rambam health Care campus

skol@rambam.health.gov.il

97247773232

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, IVF Unit

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 29, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 8, 2015
• Results First Posted: June 8, 2015

Record last verified: 2015-05

Locations

IL (1)