Clinical Study to compare the effect of two different vaginal application forms of the hormone progesterone (Cyclogest® Pessary and Crinone® 8% Gel) on pregnancy rates after artificial fertilization.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 766

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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