Infertility Clinical Trial
— XpectOfficial 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
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 442 |
Est. completion date | July 24, 2008 |
Est. primary completion date | July 24, 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Number of Oocytes | The total number of oocytes on the Day of oocyte pick-up is an indication of ovarian response | 12 weeks | |
Secondary | Number of Mature Oocytes | This is not a prespecified key secondary outcome; therefore, results will not be disclosed. | 12 weeks | |
Secondary | Number of Follicles on Stimulation Day 8 | This is not a prespecified key secondary outcome; therefore, results will not be disclosed. | 12 weeks | |
Secondary | Number of Follicles on Day of hCG | This is not a prespecified key secondary outcome; therefore, results will not be disclosed. | 12 weeks | |
Secondary | Number of Fertilized (2PN) Oocytes | This is not a prespecified key secondary outcome; therefore, results will not be disclosed. | 12 weeks | |
Secondary | Number of Good Quality Embryos | This is not a prespecified key secondary outcome; therefore, results will not be disclosed. | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A |