Infertility Clinical Trial
— GM-CSFOfficial title:
The Effect of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) During in Vitro Culture of Human Embryos on Subsequent Implantation Rates.
Verified date | April 2015 |
Source | Origio A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines AgencySweden: Medical Products Agency |
Study type | Interventional |
This study is to assess whether addition of 2 ng/ml GM-CSF into a specific culture medium will increase the chance of a pregnancy after in vitro fertilisation.
Status | Completed |
Enrollment | 1332 |
Est. completion date | September 2011 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 39 Years |
Eligibility |
Inclusion Criteria: - The couple or single woman has signed an informed consent form before any trial-related activities. - In Vitro Fertilization (IVF) or IntraCytoplasmic Sperm Injection (ICSI) treatment indicated - 25-39 years of age (both inclusive) - Regular menstrual cycle: 21-35 days (both inclusive) - Women treated with a standard Gonadotropin-Releasing Hormone (GnRH) agonist or antagonist protocol and a Follicle Stimulating Hormone (FSH) / human Menopausal Gonadotropin (hMG) starting dose between 100 and 300 IU daily. - human Chorionic Gonadotropin (hCG) administration when the leading follicle has a calculated diameter of minimum 17 mm, or the day after. - At least 3 follicles with a calculated diameter of = 14 mm at the day of hCG. Exclusion Criteria: - The woman has previously participated in the DK001 study. - Use of assisted hatching. - Indication for Testicular Sperm Aspiration (TESA) or Percutaneous Epididymal Sperm Aspiration (PESA) - Any medical conditions or genetic disorders prohibiting IVF/ICSI or interfering with the interpretation of results of the study (including pre-implantation genetic diagnostics). - Use of any investigational drug within 30 days before oocyte retrieval - Any severe chronic disease of relevance for reproductive function. - Oocyte donation patients (donor or recipient). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Ciconia Aarhus Privathospital, Fertilitetsklinikken | Aarhus | |
Denmark | Maigaard Fertilitetsklinik | Århus | |
Denmark | Brædstrup Sygehus; IVF-Klinikken | Brædstrup | |
Denmark | Rigshospitalet, Fertilitetsklinikken afd. 4071 | Copenhagen | |
Denmark | Fertilitetsklinikken Dronninglund | Dronninglund | |
Denmark | IVF-SYD | Fredericia | |
Denmark | Herlev Hospital, Fertilitetsklinikken G114F | Herlev | |
Denmark | Holbæk Sygehus, Fertilitetsklinikken | Holbæk | |
Denmark | Hvidovre Hospital; Fertilitetsklinikken afd. 455 | Hvidovre | |
Denmark | Odense Universitets Hospital, Fertilitetsklinikken | Odense | |
Denmark | Regionshospitalet Skive, Fertilitetsklinikken | Skive | |
Sweden | IVF Kliniken Öresund | Malmö | |
Sweden | Karolinska Universitetssjukhuset Huddinge, Fertilitetsenheten K59 | Stockholm | |
Sweden | Reproduktionscentrum | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Origio A/S |
Denmark, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ongoing Implantation Rate Week 7 | Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 7 in percentage of number of embryo transferred. | Approximately 5 weeks from oocyte pick-up (corresponding to 7 weeks from ovulation) | No |
Secondary | Number of Top Quality Embryos (TQE´s) | Number of 4-5 cell embryo at 44 hours,at least 7 cell embryo at 68 hours, maximum 20% fragmentation, equally large blastomeres (less than 25% difference in size),No signs of multinucleation. Calculated in percentage of number of 2 pronuclei (2PN) oocytes. | 3 days from oocyte pick-up | No |
Secondary | Live Birth | Subject having at least one live birth. Including a foetus which breathes or shows any other evidence of life after expulsion/extraction from its mother. The definition is independent of the duration of the pregnancy (ICMART/WHO criteria). | Until 7 days after birth | Yes |
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 |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A |