Clinical trial NCT01178931: Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support
Official title: Oral Dydrogesterone Versus Vaginal Progesterone Gel in the Luteal Phase Support: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Luteal Phase Defect
Keywords: IVF
luteal phase support
oral progesterone
vaginal progesterone
pregnancy rate
safety
tolerability
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 853
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 10 weeks
measure: Satisfaction
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Center Sisters of Mercy
Study officials:
affiliation: Department of Human Reproduction, University Hospital Center Sisters of Mercy
name: Jozo Tomic, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Human Reproduction, University Hospital Center Sisters of Mercy
name: Vlatka Tomic, M.D.
role: STUDY_CHAIR
References:
citation: Tomic V, Tomic J, Klaic DZ, Kasum M, Kuna K. Oral dydrogesterone versus vaginal progesterone gel in the luteal phase support: randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Mar;186:49-53. doi: 10.1016/j.ejogrb.2014.11.002. Epub 2014 Nov 20.