Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support
Recruitment status was Recruiting
The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Tolerability of Dydrogesterone and Intravaginal Progesterone in the Luteal Phase Support|
- 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: 8 weeks ] [ Designated as safety issue: Yes ]The side effects included the occurrence of nausea/vomiting, constipation/diarrhea, abdominal pain, dizziness, headache, breast fullness, perineal irritation, vaginal discharge and bleeding.
- Satisfaction [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Satisfaction score is determinate on the 5-point level scale with 1 being "the least satisfied" and 5 being "the most satisfied" and tolerability by yes and now answers regarding side effects that the supplement could cause.
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||October 2011 (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 8 week.
Drug: Oral dydrogesterone
Other Name: Duphastone (Solvay Pharmaceuticals)
Experimental: Crinone 8% vaginal gel
Control group is receiving vaginal gel, 1x90mg, until a pregnancy test or in the case of pregnancy until 8 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.
|Contact: Vlatka Tomic, M.D.||email@example.com|
|University Hospital Center Sisters of Mercy||Recruiting|
|Zagreb, Croatia, 10000|
|Contact: Vlatka Tomic, MD 00385989794764 firstname.lastname@example.org|
|Principal Investigator: Vlatka Tomic, M.D.|
|Principal Investigator: Jozo Tomic, M.D.|
|Sub-Investigator: Djurdja Zigmundovac Klaic, M.D.|
|Sub-Investigator: Krunoslav Kuna, M.D., PhD|
|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|