Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF)

May 18, 2011 updated by: Ferring Pharmaceuticals
This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.

Study Overview

Status

Status

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

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.

Detailed Description

This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.

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.
Interventional

Enrollment (Actual)

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.
1211

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

14 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  1. Pre-menopausal females between the ages of 18 and 42 years Non-smokers. For females who are past smokers, they must have stopped tobacco usage for at least 3 months prior to baseline visit.
  2. Early follicular phase (day 2-4) FSH (follicle stimulating hormone) less than or equal to 15 IU/L and Estradiol within normal limits
  3. LH (luteinizing hormone), PRL (prolactin), T (testosterone), DHEA-S (dehydroepiandrosterone sulfate) and TSH (thyroid-stimulating hormone), within the normal limits for the clinical laboratory, or considered not clinically significant by the investigator within 6 months prior to screening.
  4. Negative serum hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and rapid plasma reagin tests within 3 months prior to screening
  5. Seropositive for rubella and varicella and ABO grouping and Rho (D) typing prior to screening
  6. Documented history of infertility (eg, unable to conceive for at least one year or for 6 months for women ≥38 years of age or bilateral tubal occlusion or absence).
  7. Male partner with recent (within 6 months prior to screening) semen analysis showing normalcy adequate for IVF by standard WHO and/or Kruger criteria. Donor sperm may be used, if indicated, provided that it meets standard WHO criteria.
  8. Normal Transvaginal ultrasound at screening (or within 14 days of screening) with presence of both at least ovaries without evidence of clinically significant abnormality consistent with findings adequate for ART with respect to uterus and adnexa (no hydrosalpinx or clinically relevant uterine fibroids).
  9. At least one cycle with no fertility medication prior to screening.
  10. Hysterosalpingography, hysteroscopy, or sonohysterogram documenting a normal uterine cavity.
  11. Negative pregnancy test on the day of pituitary down regulation (prior to administration of GnRH agonist).
  12. Signed informed consent.

Exclusion Criteria

  1. Requires Donor oocyte or embryo recipient; gestational or surrogate carrier
  2. Undergoing blastomer biopsy and other experimental ART procedures
  3. Inadequate number of oocytes defined as fewer than 3 oocytes retrieved in the study cycle
  4. Presence of any clinically relevant systemic disease (eg, insulin-dependent diabetes mellitus).
  5. Surgical or medical condition which in the judgment of the Investigator or Sponsor may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
  6. Subjects with a body mass index (BMI) of greater than 34 at time of Screening.
  7. Previous IVF or ART failure due to related to either a sperm/fertilization problem which resulted in unsuccessful fertilization or an ART with a poor response to gonadotropins. Poor response is defined as development of less than 2 mature follicles or history of 2 previous cycle cancellations prior to oocyte retrieval due to poor response.
  8. Presence of abnormal uterine bleeding of undetermined origin.
  9. Current or recent substance abuse, including alcohol and tobacco. (Note: Patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed).
  10. History of chemotherapy (except for gestational conditions) or radiotherapy.
  11. Currently breast feeding, pregnant or contraindication to pregnancy.
  12. Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests.
  13. For male partner, obvious leukospermia (> 2 million WBC/mL) or signs of infection in semen sample within past 2 months of pituitary down regulation; if either of these conditions exists, male should be treated with antibiotics and retested prior to his partner's pituitary down regulation.
  14. Documented intolerance or allergy to any of the medications used including the study medication.
  15. Participation in any experimental drug study within 60 days prior to Screening.
  16. Use of any of the following medications during the pretreatment and treatment phase: hormonal drug products (use of oral contraceptives during down regulation is allowed), progesterone creams, hydrocortisone and other steroid drug products, and fertility modifiers such as insulin sensitizers.
  17. History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: 1
Endometrin 100mg BID
Drug: Endometrin
Endometrin 100mg BID x 10weeks
Drug: Endometrin
Endometrin 100mg TID x 10weeks
Experimental: 2
Endometrin 100mg TID
Drug: Endometrin
Endometrin 100mg BID x 10weeks
Drug: Endometrin
Endometrin 100mg TID x 10weeks
Active Comparator: 3
Crinone
Drug: Crinone
Crinone QD x 10weeks

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
Ongoing pregnancy.
Time Frame: 6 weeks
6 weeks

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
Biochemical pregnancy, clinical pregnancy, pregnancy outcome.
Time Frame: 1 year
1 year

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.
Ferring Pharmaceuticals

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.
July 1, 2005

Primary Completion (Actual)

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.
April 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2006

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).
February 23, 2006

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.
February 23, 2006

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.
February 27, 2006

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.
May 19, 2011

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.
May 18, 2011

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.
May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • FE999913 2004-02

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings