A Novel Stimulation Protocol and the Conventional Low Dose Step-up and Step Down Regimens

April 26, 2010 updated by: Genesis Center for Fertility & Human Pre-Implantation Genetics

Conventional Step-up, Step Down and a Novel Stimulation Regime in Controlled Ovarian Stimulation of Older Than 30 Years PCOS Patients Undergoing IVF- A Prospective Randomized Study.

This study is designed to compare the efficacy of a novel stimulation protocol with the conventional low dose step-up and step down regimens in older than 30 years PCOS patients undergoing in vitro fertilisation. The novel regime was proposed under the basis of the combined effectiveness of the two standard protocols to induce a uniform follicular growth and forms a continuation to the author's previously published results examining a similar approach in younger PCOS candidates. In total 225 patients have been recruited for this study. The stimulation protocol will be assigned under the basis of prospective randomization using sealed and numbered envelopes. All patients will be down regulated using a desensitisation agent administered on day 2 of spontaneous or induced withdrawal bleeding. The initial dosage in the low dose step-up regimen (group A) will be 150 IU/d of FSH for the first 6 days followed by an increase of 75 IU thereafter. In the step-down regimen (group B) patients will administer a starting dose of 300 IU/d of FSH for the first 3 days followed by a decrease to 225 IU/d for the next 3 days. This dosage will be further decreased to 150 IU/d or sustained at 225 IU (according to the initial response) until the day of the hCG injection. Group C, patients received 225 IU on day 1 followed by a decrease to 150 IU on day 2. On day 3 the dosage will be increased back to 225 IU. This alternation of injection dosage will be followed until day 6. According to the initial ovarian response the dosage will be sustained at 225 IU/d or 150 IU/d until the day of the hCG injection. The 10,000 IU hCG will be administered when at least two follicles had reached a mean diameter of 18 mm and the serum E2 levels were consistent with the ultrasound findings. Egg retrieval will be undertaken at 35 hours after the administration of the hCG injection. Oocytes recovered will be inseminated 4 hours post egg collection. Patients will receive 3 embryos on the third day of development. The luteal phase will be supported by progesterone suppositories starting on the day of the egg collection. A positive outcome will be detected by a serum β-hCG analysis 13 days after embryo replacement. The presence of a fetal heart pulse on ultrasound 3 weeks later confirmed a clinical pregnancy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

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

  • Cyprus
      • Limassol, Cyprus, 3025
        • Genesis Centre for Fertility and Human Pre-implantation Genetics

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 32 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

PCOS is defined as the presence of polycystic ovaries, described as enlarged under US with more than 10 cysts (2 and 8 mm) in mean diameter and symptoms of oligomenorhrea/ amenorhea, high LH/FSH ratio, obesity, hyperandrogenism hirsuitism and acnes), and withdrawal bleeding after administration of progesterone. All women had either failed to ovulate after receiving a maximum daily dosage of 100-150 mg of clomiphene citrate for 5 days or failed to conceive after at least three ovulatory cycles using CC or gonadotropin treatment. Other inclusion criteria included: patients between 30 and 36 years old with patent fallopian tubes, no previous IVF attempts, and nortmo-spermic partners.

Description

Inclusion Criteria:

  • Failure to ovulate after CC treatment

    • Over than 30 years of age No Previous IVF attempts
  • Patent Fallopian Tubes
  • Normo-spermic partners

Exclusion Criteria:

  • Secondary Infertility
  • Younger than 30 years
  • Older than 36 years
  • Other infertility cause

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
75 PCOS Patients - step up regime
Group A will be comprised of 75 patients and these will receive a low dose step stimulation regime
Drug: mode of gonadotropin administration
Low dose step-up administration Step down administration sequential administration
75 PCOS patients -step down regime
Group B will be comprised of 75 patients who will receive a step down regime of stimulation
Drug: mode of gonadotropin administration
Low dose step-up administration Step down administration sequential administration
75 PCOS patients - sequential regime
Group C will be comprised of 75 patients who will be treated using a sequential stimulation regime
Drug: mode of gonadotropin administration
Low dose step-up administration Step down administration sequential administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pregnancy Rate
Time Frame: The primary outcome measure will be assessed upon completion of the study estimated to September 2010
The primary outcome measure will be assessed upon completion of the study estimated to September 2010

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Ovarian Response
Time Frame: The secondary outcome measure will be assessed upon completion of the controlled ovarian stimulation and the egg collection procedures. This parameter will be made known at least 5 weeks prior to the primary outcome mesure being availablle
The secondary outcome measure will be assessed upon completion of the controlled ovarian stimulation and the egg collection procedures. This parameter will be made known at least 5 weeks prior to the primary outcome mesure being availablle

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genesis Center for Fertility & Human Pre-Implantation Genetics

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • pcos
  • PCOS2
  • livfe67

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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