Luteal phase support after IVF
Conditions
Interventions
Trade Name: Cyclogest® 400 mg
Pharmaceutical Form: Pessary
INN or Proposed INN: PROGESTERONE
CAS Number: 57-83-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400
Sponsors
Actavis Group PTC ehf.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age (calculated from date of birth) at randomization between 18 and 40 years 2. Body mass index = 18 and = 30 kg/m2 3. Infertility due to any of the following factors: tubal factor, mild endometriosis (American Society for Reproductive Medicine [ASRM] stage 1 to 2), male factor, unexplained infertility 4. Presence of at least one ovary, and uterine cavity without significant abnormalities 5. First, second, or third fresh cycle in the present series of assisted reproductive technology (ART) 6. = 4 oocytes were retrieved in the current ART cycle 7. Serum follicle stimulating hormone (FSH) level = 12 IU/L (on menstrual cycle day 1 to 5) within any menstrual cycle within one year prior to randomization 8. ART procedure according to: • undergoing routine down-regulation with gonadotropin releasing-hormone (GnRH) agonist or using GnRH antagonist • undergoing stimulation regimen with FSH and/or human menopausal gonadotropin (hMG) with total starting dose ranging from 100 IU to 300 IU per day, and a maximum total dose of up to 450 IU per day • human chorionic gonadotropin (hCG 5000 or 10000 IU) trigger injection when at least 3 follicles with diameter = 17 mm are observed during TVUS • oocyte retrieval (OR) is planned for 35 to 37 hours after hCG trigger injection • ET on Day 2 or 3 after OR (1 to 3 embryos depending on number of previous fresh cycles and age of woman according to the site's clinical practice and national legislation if applicable) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 766 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of pregnancy 2. More than two previously failed complete ART fresh cycles 3. Donor egg recipient 4. Any contraindication to being pregnant and/or carrying pregnancy to term 5. Presence of any medical condition for which the use of progesterone is contraindicated, (e.g. porphyria, etc.) 6. Known postmenopausal status 7. Vaginal abnormalities (including untreatable abnormal discharges) 8. History of gynecological neoplasia (breast, uterus, ovary, cervix, vagina) 9. Presence of clinically significant endometriosis (> 1 cm ovarian endometrioma) 10. Uterine fibroids suspected to affect study procedures (assessed by ultrasound or hysteroscopy (HSC) / hysterosalpingogram (HSG)) 11. Known blood coagulation disorders 12.Epilepsy, migraine with neurological symptoms, cardiac or renal dysfunction, cholelithiasis 13. History of or current clinically significant depression, at the discretion of the investigator 14. Occurrence of severe ovarian hyperstimulation syndrome (OHSS) according to Golan (Grade IV, V or VI) 15. Present use or use within 2 months prior to start of the study, medication of the following drugs: phenytoin, phenobarbitone, phenylbutazone, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, rifabutin, nevirapine, efavirenz, nelfinavir, ritonavir, griseofulvin, ketoconazole 16. Administration of investigational drugs within 2 months prior to start of study medication 17. Known hypersensitivity to one of the study drugs or any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate non-inferiority in the achievement of pregnancy rate (fetal heart movement measured by TVUS) after 38 days of luteal phase support using Cyclogest® 400 mg bid compared to Crinone® 8% (90 mg) once daily. ;Secondary Objective: • To compare the safety and tolerability of Cyclogest® 400 mg bid to Crinone® 8% (90 mg) od when used for 10 weeks of luteal phase support. • To compare the achievement of clinical pregnancy rate (fetal heart movement measured by TVUS) after 10 weeks (70 ±3 days) of luteal phase support using Cyclogest® 400 mg bid or Crinone® 8% (90 mg) od. • To compare patient-rated convenience in the use of Cyclogest® 400 mg bid to Crinone® 8% (90 mg) od when used for 10 weeks of luteal phase support. • To compare biochemical pregnancy rates between Cyclogest® 400 mg bid and Crinone® 8% (90 mg) od after 18 days and 38 days relative to oocyte retrieval (OR). • To compare the clinical implantation rate (embryo with fetal heart movement measured by TVUS) per number of embryos transferred after 38 days of luteal phase support using Cyclogest 400 mg bid or Crinone 8% (90 mg) od. ;Primary end point(s): • The primary endpoint of the study is the clinical pregnancy rate achieved after 38 days of luteal phase support (fetal heart movement measured by TVUS).;Timepoint(s) of evaluation of this end point: Final Analysis at the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Clinical pregnancy rate achieved after 70 ±3 days (10 weeks) of luteal phase support (fetal heart movement measured by TVUS) • Clinical implantation rates per number of embryos transferred after 38 days of luteal phase support (fetal heart movement measured by TVUS) • Biochemical pregnancy rate at Day 18 and 38 after OR • The patient's evaluation of treatment convenience • The patient's evaluation of bleeding and leakage (diary) • Incidence of adverse events. ;Timepoint(s) of evaluation of this end point: Final Analysis at the end of the trial | — |
Countries
Belgium, Bulgaria, Czech Republic, Hungary, Serbia
Contacts
Public ContactProject Coordinator
Pharmaplex bvba
Outcome results
None listed