Effect of Treatment With Corifollitropin Alpha in Vitro Fertilization in Patients With Poor Ovarian Response.

June 9, 2017 updated by: Instituto de Investigacion Sanitaria La Fe

Prospective Randomized Study for the Evaluation of Controlled Ovarian Stimulation With Corifollitropin Alpha in Patients With Expected or Poor Ovarian Response in IVF Cycles

Patients who have had or are expected to have a poor ovarian response (POR), because they meet any of the criteria of Bologna, can benefit from ovarian stimulation with 150 mg of alpha Corifollitropin (CFA) (Elonva ®) as single dose for a week, in the cycles of in vitro fertilization (IVF).

In this study aims to demonstrate non-inferiority of the Corifollitropin Alpha (CFA ) versus daily administration of Human Menopausal Gonadotropin (hMG) (Menopur ®) during the first seven days of ovarian stimulation, in a protocol with gonadotropin-releasing hormone ( GnRH) antagonists

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One of the most significant problems in fertilization treatments is Controlled Ovarian Stimulation low responsiveness . The incidence of low ovarian response is estimated at around 10-25%.The wide range of prevalence reported in the literature can be explained by the lack of consensus existed as to the criteria for the low response.

The ovarian response to gonadotropin stimulation is crucial for successful assisted reproduction techniques .Cycles with low rates response was obtained and increased cancellation rate and worst pregnancy rates .

Different criteria for the definition of low response, different tests to assess ovarian reserve and different threshold values for each has been used.

In 2010 a group of experts from the ESHRE ,achieved consensus on the criteria for low ovarian response to homogenize the study groups and reach meaningful conclusions, are known as "The Bologna criteria" ,they defined the "Poor Ovarian Response" (POR).

There is not sufficient to recommend most of the proposed treatments to improve pregnancy rates in poor responders evidence.

Taking into account the profile of equivalence and safety of CFA (Corifollitropin Alpha , active of ELONVA ® ) , different studies had been concluded that CFA can be an alternative to daily injections of recombinant follicle stimulating hormone ( rFSH) in normal responders patients in vitro fertilization cycle with ovarian stimulation.But more research is needed to determine whether long-acting recombinant follicle stimulating hormone ( rFSH) is safe and effective for use in women with low and high response.

The ovarian controlled stimulation with Alpha Corifollitropin produces significantly more oocytes compared to recombinant follicle stimulating hormone (r FSH ) administrated daily in normal responders patients, For this reason , the use of Alpha Corifollitropin may be beneficial in patients with poor response which the number of oocytes retrieved is crucial for successful treatment

There have been two studies in which the results are compared after ovarian stimulation with daily rFSH vs CFA . In both shows , retrospectively and prospectively , the CFA seems to be at least as effective as hMG recombinant follicle stimulating hormone ( rFSH) daily.

There are scientific publications showing that the association of luteinizing hormone ( LH) to recombinant follicle stimulating hormone ( rFSH) can improve embryos quality and achieved better pregnancy rate . The pregnancy rate was not statistically significant , in normal responders patients.

Recently reported the beneficial effect in POR patients treated with CFA and hMG.

The IVF treatment is known to affects the physical and mental condition in patients with infertility , being the excess emotional stress one of the most important reasons for discontinuation of treatment.

The ovarian stimulation with CFA simplifies treatment , reducing the administration of multiple daily injections ,and may reduce the emotional burden on patients.

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Human Reproduction Unit of the La Fe University and Politechnic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. - Age ≥ 18 years old.
  2. - Signed informed consent to perform IVF and participation in this study.

  3. - Due to characteristics of our center not perform treatments in patients

    • 40 years old ,and being one of the Bologna criteria that we will not be able to consider ,we decided to include patients affected subsidiary infertility treatment by IVF or intracytoplasmatic sperm injection (ICSI), present one of the following factors

      1. Have a history of surgical or medical treatment as a risk factor for POR.
      2. Patients witch had have a poor ovarian response in response to the ovarian controlled stimulation (previous cycle after conventional stimulation with ≤ 3 oocytes)
      3. Patients with ovarian reserve test anti-mullerian hormone(AMH ) <1.1 ng / ml (<8 pM) or antral follicle count (AFC)<7

Exclusion Criteria:

  1. -Anovulation.
  2. -Patient with tubal factor, untreated
  3. -Patient with uterine pathology untreated
  4. - Couples with severe male factor, fresh count <5 million / ml, and azoospermia in which the patient's sperm, epididymal or testicular is used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CFA , hMG,Ganirelix,choriogonadotropin alfa,progesterone.

Corifollitropin Alfa (CFA) 150 ug from the 2nd day of the cycle for 7 days. hMG 300 IU/24h, if required from the 8th day of the Controlled Ovarian Stimulation , until the day human chorionic gonadotropin ( hCG.) Ganirelix 0.25 mg,Dose: 250μg/24h since the day observe a follicle> 14mm. Recombinant choriogonadotropin alfa,Dose: 6,500 IU, pods, when follicles> 17 mm are observed.

Micronized natural progesterone. Route of administration: vaginal. Dose: 400mg/24, from embryo transfer until the day of b-hCG.
Drug: Ganirelix 0.25 mg.
Ganirelix 0.25 mg. Route of administration: Subcutaneous use. Dose: 250μg/24h since the day observe a follicle> 14mm.
Other Names:
  • ORGALUTRAN®.
Drug: Recombinant choriogonadotropin alfa
Recombinant choriogonadotropin alfa. Route of administration: Subcutaneous use. Dose: 6,500 IU, pods, when follicles> 17 mm are observed
Other Names:
  • OVITRELLE®.
Drug: Micronized natural progesterone.
Micronized natural progesterone. Route of administration: vaginal . Dose: 400mg/24, from embryo transfer until the day of b-hCG.
Other Names:
  • PROGEFFIK®.
ACTIVE_COMPARATOR: hMG ,Ganirelix,choriogonadotropin alfa,progesterone

Human Menopausal Gonadotropin (hMG). Dose: 300 IU/24h from the 2nd day of the cycle throughout the stimulation.

Ganirelix 0.25 mg,Dose: 250μg/24h since the day observe a follicle> 14mm. Recombinant choriogonadotropin alfa,Dose: 6,500 IU, pods, when follicles> 17 mm are observed.

Micronized natural progesterone. Route of administration: vaginal. Dose: 400mg/24, from embryo transfer until the day of b-hCG.
Drug: Ganirelix 0.25 mg.
Ganirelix 0.25 mg. Route of administration: Subcutaneous use. Dose: 250μg/24h since the day observe a follicle> 14mm.
Other Names:
  • ORGALUTRAN®.
Drug: Recombinant choriogonadotropin alfa
Recombinant choriogonadotropin alfa. Route of administration: Subcutaneous use. Dose: 6,500 IU, pods, when follicles> 17 mm are observed
Other Names:
  • OVITRELLE®.
Drug: Micronized natural progesterone.
Micronized natural progesterone. Route of administration: vaginal . Dose: 400mg/24, from embryo transfer until the day of b-hCG.
Other Names:
  • PROGEFFIK®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of evolutionary gestation in each cycle
Time Frame: 20 week of gestation
Evolutionary pregnancy has been defined as gestation of at least 1 fetus reaches 20 weeks of gestation diagnosed by normal ultrasound or confirmed by live birth
20 week of gestation
oocytes (MII) rate by patient
Time Frame: participants will be followed for the duration of the cycle,an expected average of 8-16 days.
When follicular puncture occurs, we value the number of punctured follicles, total oocytes and MII oocytes
participants will be followed for the duration of the cycle,an expected average of 8-16 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events
Time Frame: participants will be followed for the duration of the cycle,an expected average of 16 days.
participants will be followed for the duration of the cycle,an expected average of 16 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Investigators

  • Principal Investigator: Roser Taroncher, La Fe University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (ESTIMATE)

April 21, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POR-ELONVA
  • 2013-002027-42 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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