Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders

NCT01732094 | Completed Phase 2

• 1 other identifier: 2012/084
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to examine the level of ovarian response and the pregnancy rates among poor ovarian responders treated with a novel treatment protocol with 150μg corifollitropin alfa followed by 300IU hMG in a long GnRH agonist protocol.

Conditions

Infertility; Poor Ovarian Response

Keywords

Poor ovarian response; Poor ovarian responders; Bologna criteria for poor ovarian response

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  10 to 12 weeks of gestation

Secondary Outcomes (3)

• Number of oocytes retrieved

  Day of oocyte retrieval

• Cycles with oocyte retrieval

  Day of oocyte retrieval

• Cycles with embryo transfer

  Day of Embryo transfer

Study Arms (1)

Corifollitropin Alfa + hMG

EXPERIMENTAL

Drug: Triptorelin; Drug: Corifollitropin alfa 150μg; Drug: hpHMG

Interventions

Triptorelin DRUG

Triptorelin 0.1 mg/1 ml solution daily from day 21 of the cycle onwards

Corifollitropin Alfa + hMG

Corifollitropin alfa 150μg DRUG

Corifollitropin alfa 150μg (single dose) 2 or 3 weeks after initiation of triptorelin

Corifollitropin Alfa + hMG

hpHMG DRUG

hpHMG 300IU daily from day 7 following Corifollitropin alfa onwards

Corifollitropin Alfa + hMG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients should fulfill the "Bologna criteria" for poor ovarian response
• At least two of the following three features must be present:
• i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC \<7 follicles or AMH \<1.1 ng/ml).
• Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT (ovarian reserve test).

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Centre for Reproductive Medicine UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate; follicle stimulating hormone, human, with HCG C-terminal peptide

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

Study Officials

• Nikolaos P. Polyzos, MD PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2012
• First Posted: November 22, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

BE (1)