Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH (Study 142003)(P05696) (Xpect)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00778999
First received: October 23, 2008
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

The success of assisted reproductive technologies (ART) is critically dependent on optimizing protocols for controlled ovarian stimulation to provide adequate numbers of good quality oocytes and embryos. This optimization is mainly valuable to a group of infertility patients (9%-24%) who respond poorly to Controlled Ovarian Stimulation(COS). It is also important for an additional 2.6% of the infertility patients who manifest a high response to gonadotropin and are at risk for hyperstimulation syndrome, a life-threatening situation. Extensive research was carried out and led to the introduction of GnRH antagonist, as an alternative to Gonadotropin Releasing Hormone (GnRH) agonist, for the prevention of premature Luteinizing Hormone (LH) surges. Further research to optimize the GnRH antagonist regimen concluded that a daily treatment with 200 IU of recombinant Follicle Stimulating Hormone (recFSH) in a GnRH antagonist regimen is safe, well tolerated and results in a good clinical outcome. This protocol is now frequently applied in the US and Europe.

Predicting a woman's response (based on the assessment of ovarian reserve) to COS is useful in determining individualized clinical management strategies for low and high responders and thus avoiding cancellation. Such prediction when based on reliable scientific evidence is valuable in consulting patients about their chances of success. A large number of studies have been performed, which used certain clinical, ultrasonographic and hormonal markers (called predictive factors), to try to optimize a COS protocol for patients who were down-regulated with a long GnRH agonist protocol. Prospective trials of predictive models have also been used to adjust the starting dose of FSH to prevent a too low or too high ovarian response. To date, however, none have been performed for women undergoing ovarian stimulation with a GnRH antagonist protocol.

The primary objective of this randomized, open-label, multicenter clinical trial was to identify one or more factors capable of predicting ovarian response in women treated with a daily dose of 200 IU recFSH in a GnRH antagonist protocol. Since many ART centers now use oral contraceptives as a means to schedule patients stimulated with recFSH and a GnRH antagonist for assisted reproduction, the trial evaluated also whether intervention with oral contraceptives affects the accuracy of predictive models for ovarian response.


Condition Intervention Phase
Infertility
Drug: Marvelon
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Clinical Trial to Identify Predictive Factors for Controlled Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH in GnRH Antagonist Regimen With or Without Oral Contraceptive Scheduling

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Total Number of Oocytes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The total number of oocytes on the Day of oocyte pick-up is an indication of ovarian response


Secondary Outcome Measures:
  • Number of Mature Oocytes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This is not a prespecified key secondary outcome; therefore, results will not be disclosed.

  • Number of Follicles on Stimulation Day 8 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This is not a prespecified key secondary outcome; therefore, results will not be disclosed.

  • Number of Follicles on Day of hCG [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This is not a prespecified key secondary outcome; therefore, results will not be disclosed.

  • Number of Fertilized (2PN) Oocytes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This is not a prespecified key secondary outcome; therefore, results will not be disclosed.

  • Number of Good Quality Embryos [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This is not a prespecified key secondary outcome; therefore, results will not be disclosed.


Enrollment: 442
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral Contraceptive
Use of oral contraceptive pills prior to controlled ovarian stimulation
Drug: Marvelon
oral contraceptive 1 tablet daily for 14 to 21 days
No Intervention: Non-Oral Contraceptive
No use of oral contraceptive pills prior to controlled ovarian stimulation

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females of couples with an indication for In Vitro Fertilization (IVF) and/or Intracytoplasmic Sperm Injection (ICSI) scheduled for their first COS treatment cycle
  • Females >18 and <=39 years of age at the time of signing informed consent
  • Body Mass Index (BMI) <= 32 kg/m^2
  • Normal menstrual cycle length; 24-35 days
  • Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed)
  • Willing and able to sign informed consent

Exclusion Criteria:

  • History of/or any current endocrine abnormality
  • Less than 2 ovaries or any other ovarian abnormality (inc.>10mm endometrioma)
  • Presence of unilateral or bilateral hydrosalpinx
  • Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >= 5cm
  • History of recurrent miscarriage (3 or more, even when unexplained)
  • FSH or LH > 12 IU/L as measured by a local laboratory (sample taken during the early follicular phase: menstrual day 2-5)
  • Any clinically relevant abnormal laboratory value (FSH, LH, estradiol (E2), Progesterone (P), total Testosterone (T), prolactin, Thyroid Stimulating Hormone (TSH), blood biochemistry, hematology and urinalysis) based on a sample during the screening phase.
  • Contraindications for the use of gonadotropins (tumors, pregnancy, lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts)
  • Contraindications for the use of oral contraceptive pills (history of (h/o) thromboembolism, breast cancer, undiagnosed vaginal bleeding)
  • Recent history of/or current epilepsy, Human Immunodeficiency Virus (HIV) infection, diabetes, cardiovascular, gastrointestinal, hepatic, renal or pulmonary disease
  • Abnormal karyotyping of the patient or her partner (if karyotyping is performed)
  • History or presence of alcohol or drug abuse within 12 months of signing the consent
  • Use of hormonal preparations within one month prior to randomization
  • Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol
  • Administration of investigational drugs within three months prior to signing the informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00778999     History of Changes
Obsolete Identifiers: NCT00628641
Other Study ID Numbers: P05696, 142003
Study First Received: October 23, 2008
Results First Received: June 23, 2009
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Contraceptive Agents
Desogestrel
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on July 28, 2014