Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support
The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support.
(Initial start date was January 2009 but not for patients' recruitment only for paper work, documents, team organization, statistical pre-work actions and to gain the official approval of Institutional Review Board. The recruitment started in October 2010 and continued until October 2013.)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Oral Dydrogesterone Versus Vaginal Progesterone Gel in the Luteal Phase Support: Randomized Controlled Trial|
- Ongoing pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Ongoing pregnancy rate is defined by the presence of gestational sac(s) with viable fetal heart beats at 12 weeks' gestation by transvaginal ultrasound.
- Number of participants with adverse events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]The side effects included the occurrence of headache, somnolence, nausea, abdominal pain, bloating, dizziness, headache, breast fullness, perineal irritation, vaginal discharge and bleeding, interference with coitus.
- Satisfaction [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]Satisfaction score is determinate on the 5-point level scale with 1 being "absolutely satisfied" and 5 being "absolutely dissatisfied" and tolerability by yes and now answers regarding side effects that the supplements could cause.
|Study Start Date:||October 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Oral dydrogesterone
Study group receiving 2x10mg of oral dydrogesterone until a pregnancy test or in the case of pregnancy until 10 week.
Drug: Oral dydrogesterone
Other Name: Duphastone (Solvay Pharmaceuticals)
Active Comparator: Crinone 8% vaginal gel
Control group is receiving vaginal gel, 1x90mg, until a pregnancy test or in the case of pregnancy until 10 week.
Drug: Crinone 8% gel
Other Name: Crinone 8% gel (Fleet Laboratories Ltd., Watford, UK)
The use of gonadotropin-releasing hormone (GnRH) agonists in the ovarian stimulation, which prevents a premature surge of luteal hormone (LH), ultimately leads to suppression of the pituitary gland and high levels of estrogen observed during induced cycles result in inhibiting effect on the implantation of human embryos.
The luteal support in in-vitro-fertilization (IVF) cycles can be prolonged using human chorion gonadotropin(hCG) and/or progesterone.
Since it has been noted that the use of hCG was related with higher risks of the onset of ovarian hyperstimulation syndrome (OHSS), progesterone is nowadays a product of choice in luteal support.
Currently vaginal progesterone is widely used, since the classic oral progesterone results in low bioavailability and lower pregnancy rate and the intramuscular progesterone (IM-P) daily injections are painful and may cause abscesses, inflammatory reactions and local soreness.
However, standard protocol for luteal phase support has not been established (i.e. optimal dosage, route or duration).
Dydrogesterone is a retroprogesterone with good oral bioavailability. Oral administration is clear advantage, due to expected higher patient compliance and better tolerability than currently used vaginal or IM-P.
We hypothesize that dydrogesterone has the same efficacy as vaginal progesterone but better tolerability due to less side effects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178931
|University Hospital Center Sisters of Mercy|
|Zagreb, Croatia, 10000|
|Principal Investigator:||Jozo Tomic, M.D.||Department of Human Reproduction, University Hospital Center Sisters of Mercy|
|Study Chair:||Vlatka Tomic, M.D.||Department of Human Reproduction, University Hospital Center Sisters of Mercy|