Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2013-001105-81-CZ
EUCTR2013-001105-81-CZ
Active, not recruiting
Phase 1

Randomized Clinical Trial to Compare the Pregnancy Rates of Vaginally Applied Cyclogest® Pessary and Crinone® 8% Gel After In-vitro Fertilization

Actavis Group PTC ehf.0 sites766 target enrollmentAugust 2, 2013
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionsuteal phase support after IVFTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsCyclogest® 400 mgCrinone® 8%

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
uteal phase support after IVF
Sponsor
Actavis Group PTC ehf.
Enrollment
766
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 2, 2013
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility 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

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))

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
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.uteal phase support after IVFTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
EUCTR2013-001105-81-BGActavis Group PTC ehf.766
Active, not recruiting
Not Applicable
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.
EUCTR2013-001105-81-HUActavis Group PTC ehf.766
Active, not recruiting
Phase 1
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.uteal phase support after IVFTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
EUCTR2013-001105-81-BEActavis Group PTC ehf.766
Recruiting
Phase 1
A randomized study comparing outcome of gestational diabetes mellitus treatment by telemedicine versus routine treatmentgestational diabetes mellitusTelemedicineRoutine careREMI application
TCTR20231014002Internal Medicine, Faculty of Medicine, Thammasat University100
Not yet recruiting
Not Applicable
Comparison of Delayed Cord clamping at one minute vs Physiologic cord clamping in terms of outcomes for the mother and babyHealth Condition 1: O82- Encounter for cesarean delivery without indication
CTRI/2024/07/070137All India Institute of Medical Sciences