Luteal Phase Defect
Conditions
Keywords
IVF, luteal phase support, oral progesterone, vaginal progesterone, pregnancy rate, safety, tolerability
Brief summary
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.)
Detailed description
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.
Interventions
oral-2x10mg
DRUGCrinone 8% gel
vaginal-1x90mg
Sponsors
University of Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* routine ovulation induction protocol with GnRH agonist * less than three prior IVF cycles * at least three aspirated oocytes * BMI \<35 kg/m2 * age \<45 years
Exclusion criteria
* history of dysfunctional uterine bleeding * acute urogenital disease * recurrent miscarriage * previous allergic reactions to a progesterone products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 12 weeks | Ongoing pregnancy rate is defined by the presence of gestational sac(s) with viable fetal heart beats at 12 weeks' gestation by transvaginal ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 10 weeks | 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 | 10 weeks | 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. |
Countries
Croatia
Outcome results
None listed